Bachem

Bachem Torrance, CA, USA
Feb 23, 2020
Full time
Your Responsibilities The Quality Engineering (QE) Director is responsible for overseeing Quality Engineering teams who support validation and qualification of equipment, facilities/utilities and cleaning validation activities for API manufacturing at both Bachem America's locations (Vista & Torrance). The incumbent will provide leadership and guidance to the QE managers and QE employees. The QE Director will lead the harmonization of validation processes at both Bachem sites. This position is responsible for managing, developing and implementing validation processes to ensure products meet the appropriate regulatory agency's validation requirements, internal company standards and current industry practices. This position will work in close cooperation with Manufacturing, Engineering and other functional areas in managing validation activities under the QE scope of work. Responsible for presenting validation practices during the regulatory agencies and customers audits. Your Tasks Hire, manage, and develop teams to support validation activities at both locations Manage continued growth, development, and retention of the team Set strategic direction for the QE organization Responsible for making key decisions and formulating policies that are aligned with strategic objectives of the QE function and Bachem Collaborate with Manufacturing, Engineering, QA and other functional areas in managing validation activities under the QE scope of work Provide equipment, facilities/utilities qualification guidance and strategy during project planning and development phases Develops key performance metrics that measure the effectiveness of the QE organization Develop validation master plan (VMP) to assure compliance with regulatory requirements Oversee or independently develop a cleaning validation strategy for equipment and parts. Develop and execute or approve cleaning validation protocols and generate validation reports Oversee or independently plan and execute validation studies for equipment, facilities/ utilities and cleaning Write validation protocols, validation final reports and Standard Operating Procedures (SOPs), and technical reports Draft or review and approve validation documentation (requirements specifications, risk assessments, validation plans, IQ, OQ, and related reports, and validation summary reports, etc.) using defined procedures Conduct and document investigations related to validation activities Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations Demonstrates commitment to the development, implementation and effectiveness of the Quality Management System per FDA, and other regulatory agencies requirements. Contribute to GMP systems improvements Your Profile Bachelor's Degree in science related field (engineering, chemistry, or equivalent) Minimum of 10 years pharmaceutical validation experience (cleaning, equipment and facilitates/ utilities) including experience in writing and execution of protocols, reports and operating procedures At least 5 years of experience in people management and leadership Experience in drug GMP manufacturing Strong knowledge of GMPs, FDA & EU guidelines/requirements related to validation Experience with root cause analysis, failure mode analysis and analyzing complex technical problems. Possess sound technical judgement Experience in writing standard operating procedures and technical reports Excellent written and oral communication skills Proficient 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 Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: Master's Degree in science related field Six Sigma Green or Black Belt 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
Feb 23, 2020
Full time
Your Responsibilities The Building Services Technician supports the Facilities, Maintenance, and other teams as needed to ensure manufacturing is performed according to schedule and quality demands. Job responsibilities include, but are not limited to, basic maintenance tasks for facilities and equipment, preparing Your Tasks Follow Standard Operating Procedures (SOPs) and approved directions to perform basic maintenance tasks on facilities and equipment Follow SOPs and approved directions to clean glassware and equipment used in GMP processes Maintain cleaning logs and maintenance logs Maintain stock of parts, supplies, materials, and tools within areas of responsibility Assist in equipment calibration program Follow approved GMP manufacturing directions such as Standard Operation Procedures, Standard Test Procedures, and related activities 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 Follow and maintain Good Documentation Practices. Investigate any process deviations, write process deviation reports and initiate document change requests Your Profile High school diploma/GED or ability to obtain one in 12 months. 1-3 years glass washing and/or facilities or equipment maintenance Ability to safely work with hazardous materials, chemicals, and machines Ability to understand written and verbal instructions in English and communicate effectively in English Flexibility of working hours based on business needs, may include some nights and occasional weekends 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: Los Angeles
Bachem Torrance, CA, USA
Feb 23, 2020
Full time
Los Angeles Area Your Responsibilities The Business Development Manager will be responsible for actively selling NCE and Generic products and services to prospective customers, and manage business relationships to deliver year on year revenue and pipeline targets. Must maintain a thorough understanding of the customer's business and act as an advocate internally to cultivate and maintain positive customer relationships. The BD manager will need to leverage internal team expertise (Project Management, Regulatory, R&D, etc.) to resolve problems and add value to company's offerings. Your Tasks Pursue new business opportunities consistent with company's capabilities, and develop value propositions and action plans to increase the project portfolio/pipeline Maintain and utilize specified account KPI measures (including accounts receivable) and business systems to confidently forecast revenue and demonstrate a high level of account management and control Leverage the standard sales process and tools, business systems, and appropriate business support functions to support new customer and new project acquisitions Distill customer requirements and qualify project leads before presenting to operational functions Leverage internal team expertise to resolve problems and follow through on commitments, elevating critical issues to the appropriate management level for removal of organizational barriers to resolve customer problems Monitor competitive activity and trends within the industry and continually adapt presentation and product offerings for contemporary image. Plan and perform the selling, proposal, and contract negotiation processes Plan and perform the development and deployment of robust value propositions and action plans to close deals effectively and maximize margin Maintain CRM for customer accounts Collate and feedback relevant market and account intelligence from the field to support on-going development of Bachem's competitive intelligence and market positioning Remain engaged in ongoing projects to help ensure that deliverables, time lines, quality standards, and (most important to this role) customer expectations are met Gather and communicate relevant market information to sales and marketing management Ensure that quotes and meeting updates are submitted in a timely manner Attend trade shows, seminars, and other industry events, while actively engaging with those participants in order to represent company business interests and increase brand awareness Support sales management by performing sales-related research and reporting as assigned Your Profile BS degree in science-related field 3-5 years of experience in business development within a CMO/CDMO, or other direct exposure to API manufacturing, sourcing, or development Demonstrated negotiation and presentation skills The ability to serve as a business partner, and build relationships based on trust, engagement, and long term commitment The ability to travel up to 40% (50% to meet goals) for customer meetings, conferences, and seminars 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: MS or PhD a plus Project management skills/experience Knowledge of peptide synthesis Knowledge of pharm/biotech markets and related global trends Ability to pursue and close deals, and maintain motivation when faced with challenging situations Experience with Salesforce or other CRM tool 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
Feb 23, 2020
Full time
Your Responsibilities The Facilities Technical Coordinator, under moderate supervision, supports the Facilities technicians and management, maintaining equipment and calibration records, scheduling and planning contractor and vendor visits, and planning and reviewing preventative maintenance tasks and schedules. Your Tasks Maintains, both in physical and digital formats, calibration, preventative maintenance, and reactive/corrective maintenance records using Good Documentation Practices As needed, prepares data for import/export from/to different systems Creates purchase requisitions for materials, parts, and services as needed, following up with vendors and contractors to ensure timely delivery of parts and rendering of services Performs audits of rooms and equipment to ensure facility and machinery are in audit-ready states Operates in cross-functional teams (with both internal and external stakeholders) to plan and schedule critical preventative, predictive, and reactive maintenance and facilities work while minimizing impact on production Maintains asset listing database Assists in drafting new and revision of existing SOPs, associated fillable forms and Equipment Specifications Participates in training programs which result in the development of a successful working understanding of the material presented, and to become proficient in assigned duties and tasks Complies with all Company policies and procedures, including safety rules and regulations Your Profile College degree or High School diploma plus at least 5 years of relevant experience. Ability to maintain high level, compliance-oriented documentation and audit trail for facilities and equipment. Knowledge of Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), ISO and other Regulatory requirements Basic familiarity with working in an industrial, preferably biotechnical/pharmaceutical, production facility Working knowledge of industrial equipment, including but not limited to pumps, gearboxes, and air handlers Excellent written and oral communication skills Intermediate 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 with internal and external stakeholders in a proactive and solution-focused manner, including keeping management aware of potential issues Detail-oriented with the ability to accurately and correctly complete and audit equipment and calibration records 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 Preferred: College Degree plus over 5 years experience in a GMP production environment Advanced computer knowledge, including knowledge of Computerized Maintenance Management Systems and knowledge of advanced tools and techniques in Microsoft Office and Microsoft Excel 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
Feb 23, 2020
Full time
Your Responsibilities The Quality Assurance Manager of Manufacturing and Batch Compliance is responsible for operations related to Quality Assurance activities including the manufacturing floor quality oversight, GMP documentation and batch record review. Your Tasks Management of the assigned team Review and/or approval of master batch records and executed batch records Review and/or approval of technical protocols and reports Review and/or approval of quality records e.g. deviations, investigations, CAPA's Responsible for evaluating shipment data loggers using Libero Manager software. Compile risk assessments in case of violating shipping conditions Ensure GMP compliance and continuous improvement of BTO's quality system Responsible for ensuring and improving compliance of the assigned Manufacturing units Write/review/approve standard operating procedures (SOPs) Ensure timely and accurate production room and daily dispensary clearances Ensure timely and accurate GMP shipment clearances Support customer & regulatory audits. Participate in responses to audit observations. Review and/or approval of trending data Review and/or approval of Change Controls QA representative in project teams e.g. harmonization of systems and processes across Bachem sites, implementation of new systems or processes Other responsibilities may be assigned by supervisor Your Profile Bachelor's Degree in Science related field, Chemical Engineering, Biology or equivalent Minimum of 5 years' experience in a GMP/regulated industry Minimum of 3 years in QA management position Experience in GMP manufacturing environment, Quality Assurance, Quality Control Experience with 21 CFR Parts 210, 211, ICH Q7 Experience with GMP document control Experience in both internal and external auditing Ability to work with regulatory agencies Strong technical writing skills 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: Los Angeles
Bachem Torrance, CA, USA
Feb 22, 2020
Full time
Production Chemist I Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership. In order to continue our organic growth, we are constantly looking for talent. 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
Feb 22, 2020
Full time
Production Chemist II Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership. In order to continue our organic growth, we are constantly looking for talent. 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
Feb 22, 2020
Full time
QC Scientist II BSD Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership. In order to continue our organic growth, we are constantly looking for talent. Your Responsibilities The QC Scientist II performs laboratory day-today operations, guides and interacts with QC and department personnel to accomplish goals and objectives as directed by supervisor. Other duties include performing raw material testing, final product testing, QC documentation and related GMP activities. Your Tasks Maintain and perform daily operations of the QC on a daily basis in coordination with the QC Director/Supervisor to include testing of raw material/peptide samples and prioritizing projects Write and work with other QC Staff and other Department in the creation and approval of control documents such as specifications, SOPs, STMs, etc. Maintain and perform regular verification of the QC equipment for GMP compliance regularly in coordination with QC Director / Supervisor Implement and maintain GMP procedures such as following SOP's, Standard Testing Procedures (STP's), written procedure and maintaining proper documentation as necessary for Quality Control Test, review, and release raw material used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy Receive, test and release final product peptide manufactured at Bachem Test and release in-process control samples used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy Maintain a cGMP quality level of work for the QC operations to include training, documentation and procedural work Write/revise specifications as necessary, performing analytical analysis and reviewing data for completeness and accuracy Write standard operating procedures, standard test procedures and other related GMP documentation Implement and maintain GMP procedures such as following written procedure and maintaining proper documentation as necessary for Quality Control Perform QC analysis to include: HPLC, UPLC, Water, Mass Spec, UV, GC, melting point, Optical Rotation, TLC and misc. wet chemistry lab work and other related analytical equipment used for control quality of the GMP facility. This work may include calibration and validation of these methods Control raw material used in the manufacturing facility for GMP to include receiving, quarantine, testing and QC release Investigate any deviation or out of specification as necessary related to QC work performed as instructed by supervisor Execute validations as necessary to include QC Analytical methods performed, other validations to support the quality of the manufacturing facility Follow safety guidelines for handling, disposal and use for a peptide manufacturing company using toxic and/or large volumes of chemicals Support validation, and stability as necessary to include but not limited to analytical work, documentation and quality GMP procedures Your Profile Bachelor's Degree in Chemistry or related field Minimum of 5 years' experience in the GMP industry Use of analytical techniques/ instruments, such as, HPLC, GC, etc. and computer skills 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 Ability to review Certificate of Analysis for Reagents for the creation of specification documents Organization skills to support the department in the creation and approval of controlled documents in a timely manner Flexibility of working hours based on business needs, may include some nights and occasional weekends Preferred: Experience with Peptides Technical writing experience Master's degree in Chemistry or related field Experience with Equipment Maintenance Programs 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
Feb 22, 2020
Full time
Your Responsibilities The Validation Engineer II fulfills a critical role in GMP operations. This individual must plan and execute validation studies, write validation protocols, reports and other technical documents, as well as conduct validation related investigations. The incumbent is responsible for managing the cleaning validation activities in a GMP environment including cleaning cycle development, execution of protocols and review and approval of reports. The incumbent will contribute to improvements in operations, processes and methods. Your Tasks Provide equipment, facilities/utilities qualification guidance and strategy during project planning and development phases Independently develop cleaning validation strategy for equipment and parts Develop and execute cleaning validation protocols and generate validation reports Independently plan and execute validation studies for equipment, facilities/ utilities and cleaning Manage contractors performing equipment and system qualifications Write validation protocols, validation final reports, Standard Operating Procedures (SOPs), and technical reports Review and approve validation documentation (requirements specifications, risk assessments, validation plans, IQ, OQ, and related reports, and validation summary reports, etc.) using defined procedures Independently conduct and document investigations related to validation activities Contribute to GMP systems improvements Train operations staff on protocols, procedures and technical details related to systems, equipment and cleaning processes Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies requirements Your Profile Bachelor's Degree in science related field (Engineering, chemistry, biology or equivalent) Minimum of 4 years of pharmaceutical validation experience (cleaning, equipment and facilitates/ utilities) 2-4 years of related experience in Engineering, manufacturing or quality Experience with root cause analysis, failure mode analysis, verification and validation Experience in drug GMP manufacturing Experience in writing standard operating procedures and technical reports Experience in validation, particularly cleaning validation 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: Master's Degree in science related field Six Sigma Green or Black Belt 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
Feb 22, 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 Vista, CA, USA
Feb 22, 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 Vista, CA, USA
Feb 22, 2020
Full time
Your Responsibilities The Regulatory Affairs Project Manager is responsible for managing all regulatory submissions to national and international regulatory agencies both electronically and in paper form. This includes the preparation, submission, and periodic update of drug master files and any related correspondence and Letters of Authorization/Access. This individual will also be responsible for the maintenance of regulatory dossiers, internal and external customer support, and review of GMP documents for compliance with regulatory guidelines. Your Tasks Compile and submit drug master file for active pharmaceutical ingredients and other substances (i.e. U.S., Canada, Europe, Asia, Mexico, and South America) Correspond with regulatory agencies and customers regarding submissions Compile and submit responses to questions regulatory agencies have regarding submissions Maintain schedule and complete annual reports for all regulatory submissions Maintain records of all regulatory submissions and associated Letters of Authorization/ Letters of Access Maintain records of all correspondence with regulatory agencies and customers Compile and submit Site Master Files to support GMP operations Compile technical data packages for active pharmaceutical and other substances for use by customers in the preparation of their own submissions Your Profile BS degree in Science discipline - Chemistry, Biochemistry or equivalent At least 5-8 years of relevant experience Experience corresponding and interacting with regulatory agencies, particularly with the FDA. Experience with preparation of Chemistry, Manufacturing, and Controls sections for regulatory submissions Experience with cGMP manufacturing, Quality Control, or Quality Assurance Technical Writing Skills Exposure to e-CTD Software programs 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: Experience working with regulatory agencies 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
Feb 21, 2020
Full time
Your Responsibilities Develop and train employees on utilization of maintenance schedule for new equipment Write and assist in composition of instruction and operating procedures of new equipment Support projects for facility remodeling and expansion Perform activities associated with the design and qualifications of the new and existing equipment used in a manufacturing plant Write design qualifications for qualifying batch processing tanks, filter dryers, HPLCs, filtration system, Lyophilizers, cold rooms, ultra-low freezers, HVAC, compressed air, and purified water (experience with cleaning, and automation controls) Relies on experience and judgment to plan and accomplish goals Create new process and equipment drawings based on specifications and standards Update drawings to reflect changes to existing process Maintains drawing files (CAD, PDF, and hard copies) Oversee the design and construction of new plants Troubleshoot process equipment and ensuring that equipment works to its specifications and appropriate capacities Draft of new procedures, SOP's and protocols as well as training of staff for these expectations Work with other departments, contractors and vendors Perform process development studies for new and existing projects. Write summary reports to support the process development data Write standard operation procedures, standard test procedures, master batch records and other related GMP documents Your Profile Bachelor's Degree in Engineering Minimum of 5 years' relative work experience Knowledge of cGMP, pharmaceutical manufacturing methods and engineering principles Familiar with pharmaceutical and medical device regulated environment Technical knowledge of processes, equipment and utilities (batch processing, tank, filtration, lyophilization, purified water systems etc.) Experience with Computerized Maintenance Management Systems (CMMS) Experience managing projects and providing technical assessments Exhibit detail oriented documentation skills, technical writing and SOPs 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 Preferred: Experience with Peptides General lab instrument ( GC, FTIR, NMR and KF) knowledge and operation 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: San Diego
Bachem Vista, CA, USA
Feb 21, 2020
Full time
Your Responsibilities The Senior Process Engineer/Project Lead is responsible for plans, design, development, implementation, and analysis of technical products, manufacturing processes and systems in an industrial plant with consideration of safety. Performs engineering design evaluations. Recommends alterations to development and design to improve quality of products, process and/or procedures. Maximizes efficiency by analyzing layout of equipment, workflow, assembly methods, and work force utilization. Determines parts and tools needed in order to achieve manufacturing goals according to product specification. Lead project team and drive project milestones to design, develop, project, and improve processes materials flow. Your Tasks Responsible for Design, installation, and qualification of batch processing tanks, solvent recovery system (Linde), filter dryers, HPLCs, filtration system, Lyophilizers, ultra-low freezers, HVAC, solvent distribution and recovery system, compressed air, purified water, and waste water system Lead technical activities associated with the development and qualifications of new production line and equipment Collaborate with Production and Controls Team to develop and streamline production process in automating the new and existing system by harmonizing and leveraging developed technology. Develop and train cross-functional team members on utilization and maintaining new equipment and system - by creating roadmap, improving existing process, creating new procedures, job aids, SOPs and protocols as well as training of staff for these expectations Lead and support site development and production capacity expansion efforts Develop process and provide guidance for to improve engineering and project programs Troubleshoot process equipment, and monitor and trend to ensure that equipment works to its specifications and appropriate capacities Perform process development and performance trending studies for new and existing equipment and system in support of the site preventive maintenance and continuous improvement effort Lead engineering team and coordinates engineering activities to design, develop, and execute strategic investment projects, and improve process material flow Lead activities to design new processes, modify existing designs, improve production techniques, and develop test procedures Your Profile Bachelor's Degree in Engineering Minimum of 7 years' relative work experience Working Knowledge of ASTM and ASME BPE Standards and Industry Code as it relates to Chemical, Pharmaceutical facilities or related facilities Working Knowledge of cGMP, GDP, GEP engineering principles Knowledge of CalOsha Title 8, California Building Code (CBC), AQMD & APCD rules, and FDA title 21 Technical knowledge of processes, equipment and utilities (batch processing, tank, filtration, lyophilization, purified water systems etc.) Successful track record in design, planning and project management of manufacturing or pilot plant facility expansions Handle complete project life cycle from design, planning and implementation to validation including master site planning and funding package development Experience in handling hazardous materials and chemicals Excellent written and oral communication skills 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. Ability to work independently, manage one's time, and function well in a team environment Ability to communicate effectively in a proactive and solution-focused manner, including keeping management aware of potential issues 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
Feb 21, 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
Feb 21, 2020
Full time
Your Responsibilities Develop and train employees on utilization of maintenance schedule for new equipment Write and assist in composition of instruction and operating procedures of new equipment Support projects for facility remodeling and expansion Perform activities associated with the design and qualifications of the new and existing equipment used in a manufacturing plant Write design qualifications for qualifying batch processing tanks, filter dryers, HPLCs, filtration system, Lyophilizers, cold rooms, ultra-low freezers, HVAC, compressed air, and purified water (experience with cleaning, and automation controls) Relies on experience and judgment to plan and accomplish goals Create new process and equipment drawings based on specifications and standards Update drawings to reflect changes to existing process Maintains drawing files (CAD, PDF, and hard copies) Oversee the design and construction of new plants Troubleshoot process equipment and ensuring that equipment works to its specifications and appropriate capacities Draft of new procedures, SOP's and protocols as well as training of staff for these expectations Work with other departments, contractors and vendors Perform process development studies for new and existing projects. Write summary reports to support the process development data Write standard operation procedures, standard test procedures, master batch records and other related GMP documents Your Profile Bachelor's Degree in Engineering Minimum of 5 years' relative work experience Knowledge of cGMP, pharmaceutical manufacturing methods and engineering principles Familiar with pharmaceutical and medical device regulated environment Technical knowledge of processes, equipment and utilities (batch processing, tank, filtration, lyophilization, purified water systems etc.) Experience with Computerized Maintenance Management Systems (CMMS) Experience managing projects and providing technical assessments Exhibit detail oriented documentation skills, technical writing and SOPs 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 Preferred: Experience with Peptides General lab instrument ( GC, FTIR, NMR and KF) knowledge and operation 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: San Diego
Bachem Vista, CA, USA
Feb 21, 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 Torrance, CA, USA
Feb 20, 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
Feb 20, 2020
Full time
Your Responsibilities The Senior Process Engineer/Project Lead is responsible for plans, design, development, implementation, and analysis of technical products, manufacturing processes and systems in an industrial plant with consideration of safety. Performs engineering design evaluations. Recommends alterations to development and design to improve quality of products, process and/or procedures. Maximizes efficiency by analyzing layout of equipment, workflow, assembly methods, and work force utilization. Determines parts and tools needed in order to achieve manufacturing goals according to product specification. Lead project team and drive project milestones to design, develop, project, and improve processes materials flow. Your Tasks Responsible for Design, installation, and qualification of batch processing tanks, solvent recovery system (Linde), filter dryers, HPLCs, filtration system, Lyophilizers, ultra-low freezers, HVAC, solvent distribution and recovery system, compressed air, purified water, and waste water system Lead technical activities associated with the development and qualifications of new production line and equipment Collaborate with Production and Controls Team to develop and streamline production process in automating the new and existing system by harmonizing and leveraging developed technology. Develop and train cross-functional team members on utilization and maintaining new equipment and system - by creating roadmap, improving existing process, creating new procedures, job aids, SOPs and protocols as well as training of staff for these expectations Lead and support site development and production capacity expansion efforts Develop process and provide guidance for to improve engineering and project programs Troubleshoot process equipment, and monitor and trend to ensure that equipment works to its specifications and appropriate capacities Perform process development and performance trending studies for new and existing equipment and system in support of the site preventive maintenance and continuous improvement effort Lead engineering team and coordinates engineering activities to design, develop, and execute strategic investment projects, and improve process material flow Lead activities to design new processes, modify existing designs, improve production techniques, and develop test procedures Your Profile Bachelor's Degree in Engineering Minimum of 7 years' relative work experience Working Knowledge of ASTM and ASME BPE Standards and Industry Code as it relates to Chemical, Pharmaceutical facilities or related facilities Working Knowledge of cGMP, GDP, GEP engineering principles Knowledge of CalOsha Title 8, California Building Code (CBC), AQMD & APCD rules, and FDA title 21 Technical knowledge of processes, equipment and utilities (batch processing, tank, filtration, lyophilization, purified water systems etc.) Successful track record in design, planning and project management of manufacturing or pilot plant facility expansions Handle complete project life cycle from design, planning and implementation to validation including master site planning and funding package development Experience in handling hazardous materials and chemicals Excellent written and oral communication skills 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. Ability to work independently, manage one's time, and function well in a team environment Ability to communicate effectively in a proactive and solution-focused manner, including keeping management aware of potential issues 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
Feb 20, 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