Bachem

Bachem Vista, CA, USA
Apr 03, 2020
Full time
Your Responsibilities The Production Supervisor will assist the Production Manager in ensuring that all resources are assigned skillfully and efficiently for the manufacture of pharmaceutical products while meeting timelines, quality, and quantity. Responsibilities will include supervising a team of Chemists and Technicians within the Production Managers team. He/she will be in charge of either the early/late shift operations to ensure safe, compliant and efficient function of the manufacturing plant. He/she will train and supervise all employees under their shift, schedule shifts and coordinate production processes. He/she will be responsible for enforcing health and safety policies and procedures, investigating, and reporting all accidents and incidents to the site management team. He/she must have the ability to make quick decisions and set priorities in the absence of the manager. This position will require a broad understanding of the manufacturing processes, equipment, utilities, GMP guidelines and flow of materials of the entire process. He/she will also be deputized to act on behalf of the Senior Director, Director, Assistant Director or Manager at Production meetings to provide input and feedback when necessary Your Tasks Manage a team of Production Chemists and Technicians for API Manufacturing as well as assist the manager in supervising a team of Chemist and Technicians responsible for manufacturing Supervise or if needed execute all manufacturing stages which include but are not limited to: synthesis, cleavage, cyclization, conjugation, purification, reconstitution, lyophilization and in-process analytics Responsible for managing the early/late shifts and ensuring safe, compliant and efficient functions of the department/organization Responsible for making sure team of Production Operators are in compliance with cGMP guidelines Make sure all team members are trained on new revisions of applicable documents (BPR, SOPs etc.) Supervise or if needed execute in-process analysis in all manufacturing stages Assign tasks for team members and follow up on completion Support the team with the necessary resources to ensure efficient and safe manufacturing operations Comply with SOP's, BPR's and cGMP guidelines in all aspects of the work performed Write technical reports, SOPs, BPRs, initiate process deviations, CAPA's and investigations Adhere to manufacturing schedules and timelines Propose technical and chemical improvements of the manufacturing process Track and trend data for commercial processes to monitor that the process is in a state of control Give presentations when necessary to share data, information, investigation findings etc. to the appropriate stake holders Ensure that written procedures (SOP, BPR) and cGMP guidelines are followed and are up to date Review and complete cGMP documentation Ensure efficient collaboration between Production department and other supporting departments such as Operations, Logistics, QC, and QA Train Production team members to the required standard of operation and evaluate their performances Review and approve SOPs, BPR, process deviation and investigation once needed Ensure safe, efficient and conscious use of the instruments, raw materials and other resources Ensure manufacturing and personnel safety and security in the workplace Ensure the production area is in continuous state of cGMP compliance at all times Assist in the training and evaluation of new hires to the required standards of performance Your Profile Master's Degree in Organic Chemistry, Biochemistry or the equivalent Bachelor Degree in Organic Chemistry, Biochemistry or the equivalent and a minimum of 4 years of experience in Pharmaceutical Production Working experience in cGMP manufacturing and the related documentation standards, including safety, health and compliance regulations as specified by federal, state, and local governments Thorough understanding of all manufacturing stages and in-process analytical methods Familiar with scientific, manufacturing equipment's and utilities including but not limited to production Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods. Knowledge of solvent, waste and materials flow is required. Routinely work with hazardous materials and manage hazardous waste in a satellite accumulation area. Ability to work late shifts on a continuous basis and be flexible of working hours based on business needs, may include some nights and occasional weekends Ability to work independently and manage one's time Ability to manage a production team, set priorities and follow through on commitments Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive, and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Previous leadership experience Excellent written and oral communication skills Advanced Computer knowledge, including Microsoft Office applications Preferred: Experience in the API manufacturing Experience as a Peptide or Oligonucleotide chemist Proficient with all Peptide or Oligonucleotide manufacturing stages We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: San Diego
Bachem Vista, CA, USA
Apr 03, 2020
Full time
Your Responsibilities The Production Supervisor will assist the Production Manager in ensuring that all resources are assigned skillfully and efficiently for the manufacture of pharmaceutical products while meeting timelines, quality, and quantity. Responsibilities will include supervising a team of Chemists and Technicians within the Production Managers team. He/she will be in charge of either the early/late shift operations to ensure safe, compliant and efficient function of the manufacturing plant. He/she will train and supervise all employees under their shift, schedule shifts and coordinate production processes. He/she will be responsible for enforcing health and safety policies and procedures, investigating, and reporting all accidents and incidents to the site management team. He/she must have the ability to make quick decisions and set priorities in the absence of the manager. This position will require a broad understanding of the manufacturing processes, equipment, utilities, GMP guidelines and flow of materials of the entire process. He/she will also be deputized to act on behalf of the Senior Director, Director, Assistant Director or Manager at Production meetings to provide input and feedback when necessary. Your Tasks Manage a team of Production Chemists and Technicians for API Manufacturing as well as assist the manager in supervising a team of Chemist and Technicians responsible for manufacturing Supervise or if needed execute all manufacturing stages which include but are not limited to: synthesis, cleavage, cyclization, conjugation, purification, reconstitution, lyophilization and in-process analytics Responsible for managing the early/late shifts and ensuring safe, compliant and efficient functions of the department/organization Responsible for making sure team of Production Operators are in compliance with cGMP guidelines Make sure all team members are trained on new revisions of applicable documents (BPR, SOPs etc.) Supervise or if needed execute in-process analysis in all manufacturing stages Assign tasks for team members and follow up on completion Support the team with the necessary resources to ensure efficient and safe manufacturing operations Comply with SOP's, BPR's and cGMP guidelines in all aspects of the work performed Write technical reports, SOPs, BPRs, initiate process deviations, CAPA's and investigations Adhere to manufacturing schedules and timelines Propose technical and chemical improvements of the manufacturing process Track and trend data for commercial processes to monitor that the process is in a state of control Give presentations when necessary to share data, information, investigation findings etc. to the appropriate stake holders Ensure that written procedures (SOP, BPR) and cGMP guidelines are followed and are up to date Review and complete cGMP documentation Ensure efficient collaboration between Production department and other supporting departments such as Operations, Logistics, QC, and QA Train Production team members to the required standard of operation and evaluate their performances Review and approve SOPs, BPR, process deviation and investigation once needed Ensure safe, efficient and conscious use of the instruments, raw materials and other resources Ensure manufacturing and personnel safety and security in the workplace Ensure the production area is in continuous state of cGMP compliance at all times Assist in the training and evaluation of new hires to the required standards of performance Your Profile Master's Degree in Organic Chemistry, Biochemistry or the equivalent Bachelor Degree in Organic Chemistry, Biochemistry or the equivalent and a minimum of 4 years of experience in Pharmaceutical Production Working experience in cGMP manufacturing and the related documentation standards, including safety, health and compliance regulations as specified by federal, state, and local governments Thorough understanding of all manufacturing stages and in-process analytical methods Familiar with scientific, manufacturing equipment's and utilities including but not limited to production Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods. Knowledge of solvent, waste and materials flow is required. Routinely work with hazardous materials and manage hazardous waste in a satellite accumulation area. Ability to work late shifts on a continuous basis and be flexible of working hours based on business needs, may include some nights and occasional weekends Ability to work independently and manage one's time Ability to manage a production team, set priorities and follow through on commitments Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive, and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Previous leadership experience Excellent written and oral communication skills Advanced Computer knowledge, including Microsoft Office applications Preferred: Experience in the API manufacturing Experience as a Peptide or Oligonucleotide chemist Proficient with all Peptide or Oligonucleotide manufacturing stages Experience with Manufacturing Equipment such as reactors, prep. HPLC or lyophilizers on a commercial scale ERP & training systems such as SAP and Master Controls We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: San Diego
Bachem Torrance, CA, USA
Apr 03, 2020
Full time
Your Responsibilities The Lyophilizer Maintenance Engineer will be responsible for maintenance, troubleshooting, and corrective actions for all lyophilizer equipment in current operation at the site. This individual will be responsible for all projects and services related to the lyophilizers including the timely completion of repairs while adhering to standard operating practices. In addition, he/she will be responsible for routine visual and physical inspections. Your Tasks Responsible for maintenance and operational procedure for over six freeze dryers Responsible for maintenance and operational procedure for lyophilizer equipment Participate in engineering designs, specifications selections, change of parts and implement necessary changes through engineering change control procedures Participate in lyophilization process and cycle designs; implement the necessary process change through engineering change control procedures Collaborate with the validation department regarding change control requalification and validation of change Participate in customer and end-user meetings related to lyophilization as the subject matter expert Participate in writing, review and implementation of corrective actions related to lyophilizer mechanical or process deviation Use understanding and knowledge of PLC control engineering to participate in making necessary changes in process and mechanical control Collaborate with Quality Assurance in PR and SOP writing, and participate in review and corrective action related to mechanical or process deviation of equipment Complete paperwork required for equipment and maintenance data into the department's and calibration processes Your Profile Bachelor's Degree in Electrical, Mechanical or Industrial Engineering with at least 6 years related experience or AA Degree with 10 years related experience or High school degree with 15 years experience Direct related experience with electronica controls and refrigeration system knowledge, including low temperature cascading systems and two stages compressor. Specific knowledge of vacuum systems, hydraulic system and electrical circuit and control Electronic controls and refrigeration systems knowledge, including low temperature cascading systems and two stages compressor Understanding / knowledge of PLC control, preferably Allen Bradley and OM RON. Strong analytical math and problem solving skills Proficient in reading schematics and diagrams as well as other written materials High level of safety awareness Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve equipment problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Flexibility of working hours based on business needs, may include some nights and occasional weekends Preferred: Experience with -50◦ Celsius refrigeration We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Torrance, CA, USA
Apr 01, 2020
Full time
Your Responsibilities The Production Technician I performs an integral role as part of the Production team at Bachem. This role is responsible for contributing to the safe and economic manufacture of active pharmaceutical ingredient (API) products, such as peptide or related bioorganic compounds, as a member of a production team. As a Production Technician I, you will be producing APIs from gram to multiple kg scale. The majority of responsibilities will include routine synthetic organic synthesis, the operation of manufacturing equipment and keeping track of batch documentation according to cGMP regulations. Your Tasks • Manufacturing of APIs by using solid/solution phase synthesis, cleavage, de-protection, and their purification • Carry out the necessary preparative steps self-dependent according to directions and instructions given by supervisor • Follow written procedures (SOP, BPR) and comply with cGMP guidelines • Perform proper documentation following cGMP guidelines • Adhere to manufacturing schedules and timelines • Make safe, efficient, and conscious use of instruments, raw materials, products and other resources • Ensure manufacturing and personnel safety and security in the workplace • Propose and implement technical improvements • Be a Team player and be highly flexible Your Profile • Associates Degree in Chemistry or a Science related field or • High School Diploma with 1-2 years of college coursework with an emphasis in chemistry, or science related studies • Capable of working methodically and accordingly adhering to rules and regulations • Proficient with entering and/or recording information in written or electronic form according to GMP regulations • Ability to read, understand, follow written procedures (SOPs & BPRs) and instructions provided by the immediate supervisor • Flexibility and availability for shift work • Excellent written and oral communication skills • Basic computer knowledge, including Microsoft Office • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues • Detail oriented with the ability to troubleshoot and resolve problems • Ability to work independently and manage one's time • Communicate effectively with the ability to function well in a team environment • Flexibility of working hours based on business needs, may include some nights and occasional weekends We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Torrance, CA, USA
Mar 31, 2020
Full time
Your Responsibilities The Production Technician I performs an integral role as part of the Production team at Bachem. This role is responsible for contributing to the safe and economic manufacture of active pharmaceutical ingredient (API) products, such as peptide or related bioorganic compounds, as a member of a production team. As a Production Technician I, you will be producing APIs from gram to multiple kg scale. The majority of responsibilities will include routine synthetic organic synthesis, the operation of manufacturing equipment and keeping track of batch documentation according to cGMP regulations. Your Tasks • Manufacturing of APIs by using solid/solution phase synthesis, cleavage, de-protection, and their purification • Carry out the necessary preparative steps self-dependent according to directions and instructions given by supervisor • Follow written procedures (SOP, BPR) and comply with cGMP guidelines • Perform proper documentation following cGMP guidelines • Adhere to manufacturing schedules and timelines • Make safe, efficient, and conscious use of instruments, raw materials, products and other resources • Ensure manufacturing and personnel safety and security in the workplace • Propose and implement technical improvements • Be a Team player and be highly flexible Your Profile • Associates Degree in Chemistry or a Science related field or • High School Diploma with 1-2 years of college coursework with an emphasis in chemistry, or science related studies • Capable of working methodically and accordingly adhering to rules and regulations • Proficient with entering and/or recording information in written or electronic form according to GMP regulations • Ability to read, understand, follow written procedures (SOPs & BPRs) and instructions provided by the immediate supervisor • Flexibility and availability for shift work • Excellent written and oral communication skills • Basic computer knowledge, including Microsoft Office • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues • Detail oriented with the ability to troubleshoot and resolve problems • Ability to work independently and manage one's time • Communicate effectively with the ability to function well in a team environment • Flexibility of working hours based on business needs, may include some nights and occasional weekends We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Torrance, CA, USA
Mar 31, 2020
Full time
Your Responsibilities The Chemist (Chem1) function is to develop the peptide manufacture process, manufacture GMP material and perform related activities at Bachem. Your Tasks Perform synthesis process including solution phase and solid phase peptide synthesis, peptide resin cleavage, resin cleavage with HF or other chemical cocktails Perform purification process by chromatography, crystallization and other techniques, and in-process test method Follow approved GMP manufacture directions such as Master Batch Records, Standard Operation Procedures, Standard Test Procedures and other procedures to manufacture GMP materials, perform in-process test, package the product including other related activities Perform project-planning and initiate raw material order-request. Receive raw materials, coordinate with QA/QC and Material Management for material release and monitor raw material inventories Install, test equipment, operate and maintain equipment for manufacturing and in-process testing. The equipment includes analytical HPLC and prep HPLC system, Lyophilizes, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, oven, washing systems and others used in manufacture Develop processes for purification of chemicals other than peptides Follow and maintain GMP Documentation System. Investigate any process deviation and write process deviation report. Initiate document change request. Help quality control and assurance unit to maintain equipment calibration program Routinely maintain/organize work areas (Hood, bench, floor, wall, etc.) and other designated areas at the manufacturing facility Develop peptide-manufacturing processes including peptide/protein purification by chromatography, crystallization, and other techniques, and in process test methods Assist QA/QC for monitoring raw material inventories Write Standard Operation Procedures, Standard Test Procedures, Master Batch Records and other related GMP documents Follow SOPs and approved directions to clean equipment used in GMP processes, maintain cleaning log for each equipment, assist in equipment calibration program, and dispose chemical waste generated in the manufacture Monitor compliance of Maintenance and Cleaning procedures of equipment and instruments used in GMP processes by periodically reviewing and signing off on maintenance and cleaning log for each equipment Your Profile BS degree in Chemistry or related field 1-3 years' work experience Experience with HPLC and chromatography May work with hazardous materials and chemicals Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues. Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Flexibility of working hours based on business needs, may include some nights and occasional weekends Preferred: Experience with Peptides General lab instrument (MS UV Spectrometry) knowledge and operation experience Knowledge of cGMP and FDA regulations We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Torrance, CA, USA
Mar 31, 2020
Full time
Your Responsibilities The Chemist (Chem1) function is to develop the peptide manufacture process, manufacture GMP material and perform related activities at Bachem. Your Tasks Perform synthesis process including solution phase and solid phase peptide synthesis, peptide resin cleavage, resin cleavage with HF or other chemical cocktails Perform purification process by chromatography, crystallization and other techniques, and in-process test method Follow approved GMP manufacture directions such as Master Batch Records, Standard Operation Procedures, Standard Test Procedures and other procedures to manufacture GMP materials, perform in-process test, package the product including other related activities Perform project-planning and initiate raw material order-request. Receive raw materials, coordinate with QA/QC and Material Management for material release and monitor raw material inventories Install, test equipment, operate and maintain equipment for manufacturing and in-process testing. The equipment includes analytical HPLC and prep HPLC system, Lyophilizes, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, oven, washing systems and others used in manufacture Develop processes for purification of chemicals other than peptides Follow and maintain GMP Documentation System. Investigate any process deviation and write process deviation report. Initiate document change request. Help quality control and assurance unit to maintain equipment calibration program Routinely maintain/organize work areas (Hood, bench, floor, wall, etc.) and other designated areas at the manufacturing facility Develop peptide-manufacturing processes including peptide/protein purification by chromatography, crystallization, and other techniques, and in process test methods Assist QA/QC for monitoring raw material inventories Write Standard Operation Procedures, Standard Test Procedures, Master Batch Records and other related GMP documents Follow SOPs and approved directions to clean equipment used in GMP processes, maintain cleaning log for each equipment, assist in equipment calibration program, and dispose chemical waste generated in the manufacture Monitor compliance of Maintenance and Cleaning procedures of equipment and instruments used in GMP processes by periodically reviewing and signing off on maintenance and cleaning log for each equipment Your Profile BS degree in Chemistry or related field 1-3 years' work experience Experience with HPLC and chromatography May work with hazardous materials and chemicals Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues. Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Flexibility of working hours based on business needs, may include some nights and occasional weekends Preferred: Experience with Peptides General lab instrument (MS UV Spectrometry) knowledge and operation experience Knowledge of cGMP and FDA regulations We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Torrance, CA, USA
Mar 31, 2020
Full time
Your Responsibilities The Paralegal-Contract Management is primarily responsible for daily filing of written agreements, both digital and hard copy. He/she will also be responsible for ensuring that all agreements are properly entered into electronic files, and securely maintained. The individual in this position will also be responsible for inputting contractual terms, contacts and expiration dates into databases. He/she will also be responsible for the preparation and analysis of contract status reports, customer follow-up and responding to routine internal department inquiries. Your Tasks Drafting and editing of non-disclosure agreements with expanding responsibilities in this area. Assist Contracts Manager in organizational contract development and management activities. Developing standards for contracts, including presentation of payment terms and general language and provisions. Your Profile Bachelor's degree in Business, Life Sciences or related field Minimum of 5 years' experience as an in-house corporate paralegal in a pharmaceutical, biotech, or other highly regulated environment. Minimum of three years contract management experience. Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Strong operational judgement: ability to analyze, assess, interpret data, and articulate meaningful findings Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: JD or Paralegal Certification Working knowledge of SalesForce, SharePoint and contract management software. Prior experience with Master Service Agreements and Quality Agreements We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Torrance, CA, USA
Mar 31, 2020
Full time
Your Responsibilities The Paralegal-Contract Management is primarily responsible for daily filing of written agreements, both digital and hard copy. He/she will also be responsible for ensuring that all agreements are properly entered into electronic files, and securely maintained. The individual in this position will also be responsible for inputting contractual terms, contacts and expiration dates into databases. He/she will also be responsible for the preparation and analysis of contract status reports, customer follow-up and responding to routine internal department inquiries. Your Tasks Drafting and editing of non-disclosure agreements with expanding responsibilities in this area. Assist Contracts Manager in organizational contract development and management activities. Developing standards for contracts, including presentation of payment terms and general language and provisions. Your Profile Bachelor's degree in Business, Life Sciences or related field Minimum of 5 years' experience as an in-house corporate paralegal in a pharmaceutical, biotech, or other highly regulated environment. Minimum of three years contract management experience. Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Strong operational judgement: ability to analyze, assess, interpret data, and articulate meaningful findings Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: JD or Paralegal Certification Working knowledge of SalesForce, SharePoint and contract management software. Prior experience with Master Service Agreements and Quality Agreements We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Vista, CA, USA
Mar 31, 2020
Full time
Your Responsibilities The Environmental, Health and Safety (EHS) Coordinator will be responsible for providing full time environmental health and safety support to the site operations and will ensure that all practices comply with all regulatory requirements. EHS Coordinator is responsible to create and enforce a culture of safety within Bachem's organization. The EHS Coordinator will implement programs, policies, and assessments to ensure the company is in compliance with all federal, state, and local internal health and safety rules. This individual will also be responsible for coordinating regulatory programs, training, and its permitting applications. Your Tasks Inspect and evaluate the environment, equipment and processes in working areas to ensure compliance with government safety regulations and industry standards. Protect employees, customers and the environment. Recommend changes to protect workers and educate employees on how to prevent health problems using safety-training programs. Provide daily guidance and direction in EHS programs at the employee/supervisory level to ensure a common and effective approach to safety. Maintain and update as needed SOPs for all safe work practices and equipment and utilize them in day-to-day training. Perform and contribute to the site training plans by conducting employee orientations, emergency response training, and coordination of modular training programs for the operations groups. Monitor employees' exposures and air/waste/water compliance Maintain internal and regulatory reporting including data collection and reporting including but not limited to air, storm water, industrial waste water, and waste disposal Investigate incidents and accidents to identify their causes and find ways to prevent them in the future. Performs routine industrial and hazardous waste management activities such as vendor scheduling and waste haul oversight, and manifest tracking and filing Participate in safety site audits, inspections and routine surveys Maintains EHS&S files and records; modifies and implements compliance tracking problems and recordkeeping system Assist in the development of technical documents including EHS&S procedures, programs, and guidance documents Assists in maintaining, updating and coordinating company EHS&S training programs Develop and lead emergency evacuation program. Lead the Emergency Response Team and comply with all company policies. Respond to emergency situations during or after hours for the purpose of resolving immediate safety/security concerns Lead the safety committee meetings. Attend meetings, workshops, training, and seminars for the purpose of conveying and/or gathering information required to perform job functions Conduct routine safety observations to ensure compliance with regulatory agencies, company environment, health, and safety policies, procedures and practices Your Profile Bachelor's degree in Occupational Health, Safety or a related scientific field such as biology, chemistry or engineering. Minimum of 5 years' experience in Environmental Health and Safety role. Minimum of 3 years' work experience in the pharmaceutical/chemical manufacturing environment Familiarity and experience with local, state and federal codes as they apply to EHS&S Ability to develop and deliver safety training material to companywide associates Mechanical aptitude with the ability to read blueprints, architectural, P&IDS, schematics, mechanical and electrical documents Ability to be on call, or work off hours as needed Awareness and understanding of EHS&S policy and management system, the importance of conforming to EHS&S policies and procedures, and consequences of failing to comply with EHS&S policies and procedures Ability to use test equipment, such as air monitors and water Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Outstanding analytical skills as well as a strong attention to detail as it relates to identification and interpretation of federal, state, and local safety codes Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: Certified Safety Professional (CSP) Understanding of Peptide industry We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: San Diego
Bachem Torrance, CA, USA
Mar 31, 2020
Full time
Your Responsibilities The Materials Coordinator handles and controls raw materials including dispensing and sampling operations. Responsible for the safe and efficient transportation of materials to production and ensuring the correct inventory levels are maintained. Additional duties include receiving goods from suppliers, raw material sampling, inventory control, dispensing, packaging and labeling of finished product. Prepares and maintains documentation for transactions performed on ERP system. They perform all duties as outlined in cGMP regulations and standard operating procedures. Your Tasks Responsible for providing accurate and complete documentation as per company SOP associated with production and materials management duties Ensures proper receipt of all incoming materials acquired via purchase orders. Confirms material received matches the P.O and processes the receipt transactions Interacts with Purchasing and Accounting personnel to resolve receipt and/or invoice discrepancies; coordinates and competes Return to Vendor transactions Initiates documentation per SOP for receipt of cGMP material Performs the physical tasks involved in receiving sampling and storing of raw materials, finished products, in process materials and other equipment Performs required dispensing operations according to the Master Production Records Performs final dispensing operations, (peptide packaging to include QC sampling, receiving material, and inventory verification utilizing an ISO 7 and 8 cleanroom area Utilizes chart recorders, scales, fume hoods and glove box Ensures the proper cleaning and sterilization of required containers, material and work areas Formulates and stocks the proper levels of gowning materials for the Cleanroom areas Coordinates inventory control of all raw materials and components used in production with QA Issues and transports raw materials and components for batch manufacturing Operates material handling equipment in the movement and storage of materials Coordinates material and product transfer requirements directly with production personnel Performs routine inventories, evaluates variance reports, investigates discrepancies and recommends corrective actions Reviews inventory for potential expired, scrap or obsolete material Labels material and transfers dispensed material to appropriate storage areas Performs various inventory transactions on the ERP system. Responsible for supporting complete and accurate inventory transaction documentation and files Maintains required segregation, security, labeling and storage conditions for all inventory materials Maintains clean, organized and safe work area Generates bills of lading and declarations of hazardous materials Investigates quality events as necessary or as instructed by leadership Follows safety guidelines for handling, disposal and use for a peptide manufacturing company using toxic and/or large volumes of chemicals Revises cGMP documents when required Provides recommendations to leadership regarding improved procedures. Your Profile High School Diploma or GED Minimum of 1-3 years Supply Chain experience in a cGMP life science/biotech manufacturing environment Minimum of 3 years combined experience within multi-site distribution, logistics, and warehouse operations in a pharmaceutical/biotech manufacturing environment Proficient with ERP inventory transactions Willing to work with chemicals and hazardous goods Knowledge of handling temperature sensitive products including exposure to environment in cold storage areas Ability to wear various PPE including a respirator Ability to operate material handling equipment Valid California Driver's license Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: Some College/ Degree APICs certification desired Familiarity with DOT, IATAA, and Hazardous Material regulations Strong analytical and problem solving skills Familiarity working in a clean room environment We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Torrance, CA, USA
Mar 31, 2020
Full time
Your Responsibilities The Procurement Manager will be responsible for the development and management of the procurement department at Bachem Americas, Inc. He/she will provide a Global Market Analysis of defined categories and strategic supplier management for selected suppliers. The Procurement Manager will be leading and supporting the Procurement department and supporting projects. The desired candidate will also have strong skills related to Stakeholder Management. Your Tasks Lead the purchasing team Develop Procurement Strategies for the defined categories and implement them according to the Procurement Management Process Responsible for the management of, and defining categories in Procurement Constant Monitoring of overall procurement strategies with the appropriate KPI's Responsible for price and condition of procurement items for defined categories Conduct negotiations, and tender processes to ensure internal and external requirements Sourcing and evaluation of appropriate sources for defined categories Development of Risk Management Strategies and implementation for defined categories Global Market Analysis of defined category and strategic Supplier Management for selected supplier Global Procurement Market Research, country and industry analysis Ensure a sustainable implementation of procurement strategies according to the Head of Strategic Procurement Systematic management of suppliers along the entire supplier lifecycle for defined categories and key suppliers Responsible for strategic relationship management and supplier performance with defined key suppliers Leading and participating in Procurement projects Represent Procurement as the Subject matter Expert in customer projects Work out recommendation for procurement in the project Provide documentation and information to ensure the project's success Lead the Contract-Negotiations and work out a contract in collaboration with the Contract Manager for Procurement Lead Improvement projects and represent procurement in Improvement projects in collaboration with tactical purchasing Stakeholder Management Ensure the timely release and monitoring of purchase orders to ensure the availability of raw materials and services Act as a key-user in SAP for procurement Your Profile Bachelor's Degree in Chemistry, Engineering or similar field; MBA preferred Minimum of 3 years' experience in purchasing in the Biotechnology or Pharmaceutical industry Experience in strategic procurement and supplier relationship management Good understanding for the sourcing and purchasing process in the pharmaceutical industry Excellent negotiation sills with internal and external partners and suppliers Excellent stakeholder management skills Excellent skills with working in a multi-culture environment Strong analytical skills with the ability to analyze complex data sets Strong working knowledge of SAP system Familiar with the cGMP requirements in the pharmaceutical industry Excellent written and oral communication skills Excellent computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve technical and analytical problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Vista, CA, USA
Mar 31, 2020
Full time
Your Responsibilities The Materials Coordinator handles and controls raw materials including dispensing and sampling operations. Responsible for the safe and efficient transportation of materials to production and ensuring the correct inventory levels are maintained. Additional duties include receiving goods from suppliers, raw material sampling, inventory control, dispensing, packaging and labeling of finished product. Prepares and maintains documentation for transactions performed on ERP system. They perform all duties as outlined in cGMP regulations and standard operating procedures. Your Tasks Responsible for providing accurate and complete documentation as per company SOP associated with production and materials management duties Ensures proper receipt of all incoming materials acquired via purchase orders. Confirms material received matches the P.O and processes the receipt transactions Interacts with Purchasing and Accounting personnel to resolve receipt and/or invoice discrepancies; coordinates and competes Return to Vendor transactions Initiates documentation per SOP for receipt of cGMP material Performs the physical tasks involved in receiving sampling and storing of raw materials, finished products, in process materials and other equipment Performs required dispensing operations according to the Master Production Records Performs final dispensing operations, (peptide packaging to include QC sampling, receiving material, and inventory verification utilizing an ISO 7 and 8 cleanroom area Utilizes chart recorders, scales, fume hoods and glove box Ensures the proper cleaning and sterilization of required containers, material and work areas Formulates and stocks the proper levels of gowning materials for the Cleanroom areas Coordinates inventory control of all raw materials and components used in production with QA Issues and transports raw materials and components for batch manufacturing Operates material handling equipment in the movement and storage of materials Coordinates material and product transfer requirements directly with production personnel Performs routine inventories, evaluates variance reports, investigates discrepancies and recommends corrective actions Reviews inventory for potential expired, scrap or obsolete material Labels material and transfers dispensed material to appropriate storage areas Performs various inventory transactions on the ERP system. Responsible for supporting complete and accurate inventory transaction documentation and files Maintains required segregation, security, labeling and storage conditions for all inventory materials Maintains clean, organized and safe work area Generates bills of lading and declarations of hazardous materials Investigates quality events as necessary or as instructed by leadership Follows safety guidelines for handling, disposal and use for a peptide manufacturing company using toxic and/or large volumes of chemicals Revises cGMP documents when required Provides recommendations to leadership regarding improved procedures. Your Profile High School Diploma or GED Minimum of 1-3 years Supply Chain experience in a cGMP life science/biotech manufacturing environment Minimum of 3 years combined experience within multi-site distribution, logistics, and warehouse operations in a pharmaceutical/biotech manufacturing environment Proficient with ERP inventory transactions Willing to work with chemicals and hazardous goods Knowledge of handling temperature sensitive products including exposure to environment in cold storage areas Ability to wear various PPE including a respirator Ability to operate material handling equipment Valid California Driver's license Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: Some College/ Degree APICs certification desired Familiarity with DOT, IATAA, and Hazardous Material regulations Strong analytical and problem solving skills Familiarity working in a clean room environment We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: San Diego
Bachem Vista, CA, USA
Mar 31, 2020
Full time
Your Responsibilities The Facilities Technician, in conjunction with the Facilities Maintenance Manager is responsible for assisting with the building maintenance and repairs. Your Tasks Attend to all assigned work and general services orders, including but not limited to: painting, plumbing, electrical, mechanical, construction and flooring Troubleshoot, evaluate and make recommendations during regular inspections Perform routine and non-routine equipment maintenance, modification and repairs in a timely basis Maintain effective preventative maintenance programs, as directed by Management Document repairs, adjustments and replacement of equipment per SOP's and cGMP regulations Complete and coordinate with department heads all repairs, as necessary, to offset downtime and production delays Assist maintenance contractors if applicable in trouble shooting of equipment Order parts and components for repairs as needed Assist with the organization and inventory of spare parts Maintain a clean and well organized maintenance room Provide after hours on call support including holidays Must follow all safety rules and ensure compliance In conjunction with the safety committee, develops and implements the policies and procedures necessary to adhere to all government requirements Your Profile High School diploma or GED with a minimum 4 years relevant experience Experience in electrical, plumbing, HVAC, carpentry, equipment and high mechanical ability Possess and maintain a valid driver's license and good driving record Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Flexibility of working hours based on business needs, may include some nights and occasional weekends Must be able to work a rotating on-call schedule (for weekends) Preferred: Familiarity of standard laboratory practices Environmental Health and Safety regulations We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: San Diego
Bachem Torrance, CA, USA
Mar 31, 2020
Full time
Your Responsibilities The Facilities Technician II, in conjunction with the Facilities Maintenance Manager is responsible for assisting with the building maintenance and repairs. This position is an intermediate skilled position with skillset based on an electrical background. The Facilities Technician II will work on all the electrical systems and be responsible for all electromechanical repairs. Your Tasks Maintaining electrical and electromechanical systems within the facility including but not limited to, breaker panels, generators, electrical motors and motor controls Attend to all assigned work and general services orders, including but not limited to: painting, plumbing, electrical, mechanical, construction and flooring Troubleshoot, evaluate and make recommendations during regular inspections Perform routine and non-routine equipment maintenance, modification and repairs in a timely basis Cross-train other Facility Technicians and build their current skillset Maintain effective preventative maintenance programs, as directed by Management Document repairs, adjustments and replacement of equipment per SOP's and cGMP regulations Complete and coordinate with department heads all repairs, as necessary, to offset downtime and production delays Assist maintenance contractors if applicable in trouble shooting of equipment Order parts and components for repairs as needed Assist with the organization and inventory of spare parts Maintain a clean and well organized maintenance room Provide after hours on call support including holidays Must follow all safety rules and ensure compliance In conjunction with the safety committee, develops and implements the policies and procedures necessary to adhere to all government requirements Must arrive to work on time for both scheduled shifts and unscheduled call in shifts Your Profile High School diploma Minimum of 5 years' experience as a maintenance technician or maintenance engineer Experience in electrical, plumbing, HVAC, carpentry, equipment and high mechanical ability Intermediate experience with electrical systems and controls Familiarity with VFD controllers, PLC logic controllers, chillers, boilers, electrical circuits, air handlers, air conditioners, and all general facility equipment Ability to troubleshoot malfunctions within various systems throughout the facility Possess and maintain a valid driver's license and good driving record Familiarity with building code and electrical related laws and regulations Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Flexibility of working hours based on business needs, may include some nights and occasional weekends Must be able to work a rotating on-call schedule (for weekends) Preferred: Familiarity of standard laboratory practices Environmental Health and Safety regulations We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Torrance, CA, USA
Mar 31, 2020
Full time
Your Responsibilities The Sales Force Manager is responsible for all the administration tasks of the Business Development team with particular emphasis on further development of business processes, specifically in connection with the IT systems used - SalesForce and SAP. The Manager assumes responsibility for the provision, optimization and expansion of the CRM system as well as for the smooth execution of the Quote through Order process whilst ensuring their team is capable of continuous support of the Business Development group. Your Tasks Ensure the smooth flow of order development for all customer orders Coordinate shipment to customers with/from all locations Train new employees in the ERP and CRM system Keep training documents and guideline in the ERP environment up-to-date Execution of existing reports and creation of new reports Support the BD and Sales management in administrative tasks Act as CRM Application Owner and take responsibility for: Leading global projects for continuous development of the system Implementation of approved changes Establishing and developing Salesforce administrators Onboarding new employees Creating new dashboards/reports Revision of Manuals As the ERP Process Owner, this individual will be responsible for the following: The constant questioning, improvement, documentation and implementation of business processes. Implementing processes in conjunction with other ERP teams Supporting the key users of the ERP system as well as the key-users business data within the team Development of new employees and substitutes for the key-user role as needed Regularly review and improve process strategy for ERP system Your Profile Bachelor Degree with minimum of 5 years work experience in a relevant field and 2 years in a supervisory role. In depth knowledge of SalesForce and SAP required Experience of SAP and SalesForce integration implementation preferred Strong knowledge and command of the English language. Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel, and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: Work experience in and understanding of the pharmaceutical/biotech industry Management experience We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity Nearest Major Market: Los Angeles
Bachem Vista, CA, USA
Mar 30, 2020
Full time
Your Responsibilities Note: This position is only for 2nd shift The Chemist (Chem1) function is to develop the peptide manufacture process, manufacture GMP material and perform related activities at Bachem. Your Tasks Perform synthesis process including solution phase and solid phase peptide synthesis, peptide resin cleavage, resin cleavage with HF or other chemical cocktails Perform purification process by chromatography, crystallization and other techniques, and in-process test method Follow approved GMP manufacture directions such as Master Batch Records, Standard Operation Procedures, Standard Test Procedures and other procedures to manufacture GMP materials, perform in-process test, package the product including other related activities Perform project-planning and initiate raw material order-request. Receive raw materials, coordinate with QA/QC and Material Management for material release and monitor raw material inventories Install, test equipment, operate and maintain equipment for manufacturing and in-process testing. The equipment includes analytical HPLC and prep HPLC system, Lyophilizes, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, oven, washing systems and others used in manufacture Develop processes for purification of chemicals other than peptides Follow and maintain GMP Documentation System. Investigate any process deviation and write process deviation report. Initiate document change request. Help quality control and assurance unit to maintain equipment calibration program Routinely maintain/organize work areas (Hood, bench, floor, wall, etc.) and other designated areas at the manufacturing facility Develop peptide-manufacturing processes including peptide/protein purification by chromatography, crystallization, and other techniques, and in process test methods Assist QA/QC for monitoring raw material inventories Write Standard Operation Procedures, Standard Test Procedures, Master Batch Records and other related GMP documents Follow SOPs and approved directions to clean equipment used in GMP processes, maintain cleaning log for each equipment, assist in equipment calibration program, and dispose chemical waste generated in the manufacture Monitor compliance of Maintenance and Cleaning procedures of equipment and instruments used in GMP processes by periodically reviewing and signing off on maintenance and cleaning log for each equipment Your Profile BS degree in Chemistry or related field 1-3 years' work experience Experience with HPLC and chromatography May work with hazardous materials and chemicals Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues. Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Flexibility of working hours based on business needs, may include some nights and occasional weekends Preferred: Experience with Peptides General lab instrument (MS UV Spectrometry) knowledge and operation experience Knowledge of cGMP and FDA regulations We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: San Diego
Bachem Vista, CA, USA
Mar 30, 2020
Full time
Your Responsibilities The Quality Assurance Specialist I fulfills a critical role for Quality Assurance. This individual will conduct real time batch record review, perform internal audits, contribute to GMP system improvements, write technical documents, and review GMP documentation and reports. This individual must also provide GMP and related training. Your Tasks Review validation protocols, data and reports, as assigned Coordinate assigned quality systems, such as GMP training program, deviations, CAPAs, or change controls Perform annual product quality reviews and system reviews as assigned Review raw material records Provide support to customer and regulatory audits. Conduct internal audits as assigned Implement improvements in quality systems and SOPs Review and update assigned documents, such as SOPs, including line clearances, and shipment verification, equipment qualification and documentation control Provide technical assistance on all production & quality systems documents Organize and update document room files as required Your Profile A Bachelor's Degree in Science or related field and a minimum of 1-2 years' experience in the GMP / Manufacturing setting or Associates Degree in Science or related field and a minimum of 3 years' experience in the GMP / Manufacturing setting 1-2 years' work experience in GMP manufacturing Experience in GMP manufacturing, Quality Assurance and/or Quality Control Experience with GMP document control, validation, qualification and calibration Ability to work in ISO7 and ISO8 control environment and support real time batch record review Experience in internal auditing as well as working with regulatory agencies Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues. Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: San Diego
Bachem Torrance, CA, USA
Mar 30, 2020
Full time
Your Responsibilities The Chemist II (Chem. II) function is to work in a cGMP-regulated environment manufacturing active pharmaceutical products (APIs) as well as performing related activities at Bachem. Your Tasks Install, operate and maintain equipment for manufacturing and in-process testing. The equipment includes but not limited to analytical HPLC/UPLC, prep. HPLC systems, lyophilizes, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, ovens, washing systems and others used in manufacture Perform solid phase and liquid phase synthesis, deprotect and cleave the API from the resin using chemical cocktails, containing HF, TFA, ammonium hydroxide or other chemicals Perform purification process by chromatography, crystallization and other techniques Follow approved GMP manufacture directions such as Master Batch Production Records (MBPRs), Standard Operation Procedures (SOPs), Standard Test Procedures (STMs) and other procedures to manufacture GMP materials, perform in-process test, package intermediate as well as final products and other related activities Perform project-planning and initiate raw material order-request. Receive raw materials, coordinate with QA/QC and Material Management for material release and monitor raw material inventories Follow and maintain GMP Documentation System. Initiate, investigate and closure of deviations, CAPAs, investigations, reports and related documents Routinely maintain/organize work areas (Hood, bench, floor, wall, etc.) and other designated areas at the manufacturing facility Help write and suggest improvements for Standard Operation Procedures (SOPs), Standard Test Procedures (STMs), Master Batch Records (MBPRs) and other related GMP documents Follow SOPs and approved directions to clean equipment, glassware used in GMP processes and maintain cleaning logs for each equipment. Dispose of chemical waste generated in the manufacture Monitor compliance of maintenance and cleaning procedures of equipment and instruments used in GMP processes by periodically reviewing and signing off on maintenance and cleaning log for each equipment Takeover housekeeping ownership of production equipment and rooms Help quality control and assurance unit to maintain equipment calibration, qualification and maintenance program Assist in the development of peptide-manufacturing processes including peptide/protein purification by chromatography, crystallization, and other techniques, and in process test methods Assist in the development processes for synthesis and purification of chemicals other than APIs Train other operators on SOPs, equipment and operations required on the shop floor Ensure all equipment being used for the project is adequately labeled with the status of the equipment Your Profile Minimum of 3 years' work experience Bachelor's Degree in Chemistry or related field Experienced in cGMP manufacturing Maintaining good housekeeping Excellent written and oral communication skills Communicate effectively and ability to function well in a team environment Ability to communicate in a proactive and solution-focused manner, including keeping direct supervisor aware of potential issues Flexibility of working hours based on business needs, may include some nights and occasional weekends Ability to work independently and manage one's time Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Detail oriented with the ability to troubleshoot and resolve problems Good computer knowledge, including Microsoft Word, Excel and PowerPoint Experienced using analytical HPLC/UPLC, prep HPLC system, lyophilizers, balances, solid as well as liquid phase reactors, HF cleavage equipment, diafiltration systems, water purification systems, oven, washing systems and other equipment used in manufacturing Experienced in working in a clean room environment (ISO 7 & ISO 8 classified rooms) Capable of qualifying equipment and performing routine maintenance on equipment Capable of training other operators Work with hazardous materials and chemicals Preferred: Experience in the manufacture of Peptides and Oligonucleotides Experience in GMP manufacturing as well as basic knowledge of cGMP and FDA regulations Knowledge of SAP, Master Control and other quality and ERP systems We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Vista, CA, USA
Mar 30, 2020
Full time
Your Responsibilities The Director of Quality Assurance, in conjunction with the VP of Quality, maintains systems to assure compliance regulatory and client requirements for all relevant GMP operations carried out within the organization for the manufacture of drug substances in compliance with FDA and international regulatory requirements for research, pre-clinical, clinical and commercial Active Pharmaceutical Ingredients (APIs). The person in this role will oversee Quality Assurance (QA) personnel, will ensure the review/approval of draft, and executed batch records, specifications, test methods, release and stability data, raw material testing reports, validation protocols and reports, and validation records. This position will also manage systems for tracking of document control, training, internal and external auditing, client audits, CAPAs, and deviations. The Director of Quality Assurance is responsible for daily coordination with all departments in the company to ensure that timelines are adhered to and company monthly and annual goals are met or exceeded. In addition, this position will be responsible for improving quality systems, processes and procedures to increase the overall level of compliance for the site and business. Your Tasks • Maintain and improve the company's quality system per FDA ICH Q7 requirements for drug substances and ISO 13485 for raw materials used in device and diagnostics • Familiarity with 21 CFR 210 and 211 • Coordinate regulatory documents, such as Chemistry, Manufacturing and Controls (CMC) and Drug Master Files (DMF) to meet FDA cGMP and ICH requirements • Serve as the secondary point of contact with regulatory agencies such as the FDA and foreign regulatory agencies, and participate in all regulatory inspections • Host customer quality audits, coordinate quality agreements and change notifications with customers • Coordinate supplier quality system and ensure critical suppliers are qualified through audits and questionnaires • Develop annual master validation plan and ensure validations are conducted per ICH guidelines, including cleaning validations, process validations, facility and equipment qualification, and analytical test method validation • Resolve day to day issues within functional departments and provide compliance assistance as needed • Ensure continuous improvement and effectiveness of the quality management system • Oversee and conduct GMP, ICH and ISO training to comply with regulatory requirements • Chair management review meetings and oversee quality improvement plan • Oversee CAPA, deviations, NCMR, and product complaint systems and ensure discrepancies are properly documented, investigated and completed in a timely manner • Oversee work of direct reports; distribute workload, and cross-train staff on different quality areas. Interview, hire, train, develop and manage employees • Oversee the document control function, including issuing records, maintaining electronic and hard copies of master records, and maintaining hard copies of history records • Oversee quality functions, including but not limited to deviations, CAPA, NCMR, annual product quality reviews, calibration program, DCR system, change control system, raw material release, QC record review, stability studies review, and batch record review • Establish head count needs for the QA group and recruit, train and manage personnel to meet the quality system and business needs of the company • All responsibilities are to be performed in compliance with company policy as well as with applicable domestic and international regulatory requirements • Represent QA on project teams • Manage or perform other projects as assigned Your Profile • Bachelor's Degree in Science related field • At least 10 years' work experience in a Quality field for GMP company • At least 5 years management experience • ASQ, CQA and/or CQE certification desired • Knowledge of GMP, ISO, Regulatory and FDA regulations • Ability to direct, mentor and motivate others • Excellent written and oral communication skills • Basic computer knowledge, including Microsoft Word, Excel and PowerPoint • Ability to manage critical projects to deadlines as part of an interdisciplinary team • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues • Detail oriented with the ability to troubleshoot and resolve problems • Ability to work independently and manage one's time • Communicate effectively and ability to function well in a team environment • Presentation skills, technical writing and editing skills • Ability and willingness to work flexible/extended hours and moderate travel as needed to support the business • Familiar with implementing Lean and Six Sigma concepts Preferred: • Masters or Ph.D. in Science related field • Current knowledge of drug development activities in North America • Familiarity with EU GMPs We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: San Diego