Apex Life Sciences

Apex Life Sciences Menlo Park, CA, USA
Jun 17, 2019
Full time
Our client, an established Immuno-oncology company in the South Bay is looking to add qualified CLS's to their growing team. Summary The Experienced Clinical Laboratory Scientist is responsible for testing and reporting clinical laboratory results. Responsibilities Performs and reports laboratory testing on clinical laboratory samples used to aide physicians in the diagnosis and treatment of patients Selects, implements, and evaluates results for Quality Control materials used in statistical process control of laboratory assays Troubleshoots assays and equipment for which QC materials fail to perform adequately Participates in activities required to support all necessary licensure for the clinical laboratory, including quality management functions and on-site inspections of the laboratory Responsible for maintaining updated understanding and knowledge of the methods employed in the laboratory and the use of the resulting information by physicians through continuing education activities Trains other CLS personnel and other staff in laboratory methods. May be required to monitor the activities of non-licensed personnel May be required to supervise the activities of the laboratory in the absence of an on site manager May be required to assist in assay development activities. The testing personnel are responsible for specimen processing, test performance and for reporting test results Each individual performs only those high complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities Each individual performing high complexity testing must - Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance Be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the general supervisor, technical supervisor, clinical consultant, or director Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications Education / Experience California Clinical Laboratory Scientist license in categories appropriate for the area of testing performed Minimum of 1 year of experience in a clinical laboratory setting; preferably with experience in a high complexity molecular testing environment Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
Apex Life Sciences San Diego, CA, USA
Jun 16, 2019
Full time
Our client is currently focused on utilizing its proprietary E-CEL technology as a direct therapeutic product for improving Hematopoietic Stem Cell Transplants (HSCTs), as well as offering a novel therapy for the regeneration of damaged tissues resulting from both acute and chronic disease. Research Scientist, In Vivo Research & Engineered Cell Biology Position Role & Responsibilities: Conduct pre-clinical in vivo studies, some requiring microsurgery, which test our pre-clinical engineered cell product candidates Analyze data collected from in vivo studies performed Participate or lead in design of in vivo studies Conduct and analyze 2-D and 3-D engineered cell culture and assay experiments relevant to engineered cell product candidates Works collaboratively with fellow AB team members, especially with the AB Research Team and the AB Project Management Team Education/Requirements: Master's degree or PhD in cell biology, molecular biology, biochemistry, immunology or related field and 5 or more years post-graduate hands-on laboratory experience (post-doc or industry experience) covering both in vitro and in vivo work. Enjoys a fast-paced environment where data-based changes are a constant and where proactive 'can do' attitude, sense of urgency and friendly personalities are prized. A track record of the ability to learn new in vivo surgical and modelling techniques is essential Possesses skills related to wet-lab cell-therapy translational research Various cell culture techniques, cell sorting, flow cytometry, qPCR, fluorescent microscopy, antibody assays, intra-cellular signaling detection). A successful candidate must have extensive hands-on experience in performing in-vivo animal modelling work for various potential indications. Previous experience with the following in vivo procedures: Tissue extraction and dissection, IV injection (tailvein, jugular, retro-orbital) and surgical proficiency in murine models (not limited to a specific area: e.g. intratracheal administration, partial hepatectomy, partial pneumonectomy, vascular ligation and/or thrombosis, gastrointestinal and/or vascular anastamoses, etc) Additional Desired Skills and Knowledge. Applicants with experience in various micro-surgical procedures in murine models. The applicant's ability to not only perform such surgical procedures, but also demonstrate knowledge and experience in designing such in vivo experiments would be highly regarded. Applicants with expertise in organ regeneration modelling related to inflammatory and autoimmune disease and injuries would also be preferred. Preference for candidates with experience in the fields of tissue regeneration and/or microvascular biology and vascular niches. Demonstrated expertise in translational in vivo cellular biology involving research and/or product development of cell therapy product is highly desired.
Apex Life Sciences South San Francisco, CA, USA
Jun 15, 2019
Full time
Senior Research Associate, Cell Culture Research Location: South San Francisco, CA Job Description . We are looking for a highly motivated individual to contribute towards the development of therapeutics for treating degenerative diseases. The candidate must have extensive experience in mammalian cell culture including specific experience with stem cell culture and differentiation protocols. The position requires excellent written and verbal skills. Candidate must be highly organized, detail oriented with excellent data collection and data management skills. As a tissue culture research associate at Stratacuity, you'll work under the supervision of our Senior scientist to support and expand Stratacuity cell engineering program. Essential Job Functions and Job Requirements: Small and large-scale culture of mammalian and stem cell lines Generation and differentiation of iPS-cell derived cell lines Participate in the design and optimization of co-culture models Perform cell-based assays such as migration, proliferation, apoptosis and endocytosis Manage material inventory for all cell culture activities Manage more than one type of cell culture at a given time Troubleshoot complex problems in creative and effective ways; actively participate with innovation and/or optimization of established processes to ensure project timelines are met. Compile, process and analyze data; record research procedures and results; file and maintains records. Qualifications BS/MS in Biology, Neuroscience, or related field. 2-5 years with BS or 0-2 years with MS of biotechnology industry experience required. Experience in cell processing and harvest Demonstrated ability to perform technical manipulations using aseptic technique Prior work with mammalian tissue culture practices including iPS -derived cultures is required Proficiency in developing and running-in vitro cell-based functional assays 3D culture and organoid culture experience is preferred Experience in immunology, immunostaining is desirable A strong interest in developing treatments for neurodegenerative diseases Well organized, detail-oriented data collection and data management Excellent written and verbal communication skills Ability to do scientific work independently as well as part of a team, to multitask and demonstrate flexibility, and to meet deadlines in a fast-paced and energetic start-up environment Stratacuity is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Apex Life Sciences San Carlos, CA, USA
Jun 14, 2019
Full time
The Senior Product Manager leads the development and commercialization of future versions of on-market or new product lines including new features and service components of products. This person supports the vision and strategic product roadmap for certain products with the goal of extending its leading market share and value proposition. The Senior PM is responsible for the entire product lifecycle from concept to obsolescence, evaluation, and prioritization of new features and programs, a creation of product requirements and monitoring product performance in the field. The role combines strategic thinking with execution and will require a strong cross-functional leader and influencer. PRIMARY RESPONSIBILITIES Develop and execute the product roadmap. Deliver product requirements based on customer needs and operational limitations. Manage product performance and field all product support needs, working across departments, including Product Management, Molecular Biology R&D, Statistics R&D, Software Engineering, Sales & Marketing, Clinical/Medical, Operations, Regulatory, and Business Development. Develop quantitative product performance indicators, analyze and track performance data, and identify strategies for improvement across teams. Identify business opportunities and create business cases and financial models. Conduct VOC interviews, market research, and competitive analysis as a means to test and validate product features, improve customer satisfaction and support market growth. Support product marketing in the definition of product positioning - from market launch plans, pricing, and delivering key collateral content to marketing communications. Create written, data-based arguments and presentations to achieve buy-in from stakeholders Provide internal and external stakeholders with the appropriate updates on progress, vision, product roadmap, etc. QUALIFICATIONS Bachelor's degree required, preferably in physical or life science, statistics, engineering discipline, or equivalent. Master's degree preferred. Minimum of 8 years of experience, which includes 4-5 years of product management, product/solution marketing, product commercialization, or strategic consulting experience. Experience with Prenatal products/education, medical devices, or diagnostics preferred. Expertise and experience in the Life Sciences industry preferred. KNOWLEDGE, SKILLS, AND ABILITIES Ability to lead and motivate a cross-functional team Ability to understand technology and articulate customer value/benefit propositions Basic financial/economic modeling skills Proven excellence in both written and oral communications skill Ability to collaborate and interact effectively with individuals, and influence individuals across functional areas and in team environments. Proven organizational skills and extraordinary attention to detail, with an ability to manage multiple tasks simultaneously. Demonstrated experience influencing larger groups and leading a team in a successful project. Will consider scientific or technical project leads for candidates coming from research and development roles. PHYSICAL DEMANDS AND WORK ENVIRONMENT Duties are typically performed in an office setting. This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material. Duties may require working outside normal working hours (evenings and weekends) at times.
Apex Life Sciences Berkeley Heights, NJ, USA
Jun 14, 2019
Full time
CLINICAL PROGRAMMER LEAD Clinical Data Design, Rave, Inform, Oracle Clinical) Responsibilities: Develop, program, test and maintain clinical trial databases and data entry screens using Rave in accordance with internal standards Lead collaborative cross-functional team study build meetings for in-house and outsourced studies Review edit checks for in-house and outsourced studies Perform external data loads, i.e., labs, ECGs, etc., as needed. Act as liaison with vendors to establish transfer specifications and internal standards Participate in and lead team meetings when appropriate Act as primary CRO contact, when necessary, to ensure that internal standards are implemented in all studies Provide technical expertise and support to Data Management team Control access to database and perform snapshots, database lock and freeze activities Make data, including interim data, available to company personnel and regulatory agencies when required Perform post processing of data extracts in accordance with internal standards to be delivered to Biostatistics Routinely interface with cross-functional team members Influences other functions and represents as DBO technical expertise Internal team leader who decides best course of action Coach and advise junior programmers to identify problems and solutions Review clinical programming activities and costs in contracts Assess CRO data management systems for regulatory compliance Interact with CROs in the design and development of databases that are compatible with company needs Monitor progress of clinical programming activities in CROs Participate in regular team meetings and provide input when appropriate Participate in the development of clinical programming SOPs and the development/optimization of clinical programming processes from study start up to database lock. Routine interface with cross-functional team members in creating an appropriate database, data quality assurance, and support of data cleaning activities Direct responsibility for supervising and training junior clinical programmers in the performance of their duties Managing project priorities and timelines Qualifications: BS/BA degree or equivalent in a relevant scientific discipline with 5+ years related Clinical experience Advanced knowledge of clinical database design is a must (Rave, Inform, Oracle Clinical or other systems). Safety Gateway, TSDV, Site Payments and Coder experience a plus Good communication skills; ability to work in a team environment with data managers, medical personnel, clinical monitors, statisticians, programmers, and medical writers Knowledge of FDA/ICH guidelines and industry standard practices regarding programming desired Medical or mathematics/computer science background a plus Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation Knowledge of clinical trial design and basic statistics a plus Technical project management experience a strong plus Computer skills: knowledge of MS Office program suite
Apex Life Sciences San Francisco, CA, USA
Jun 14, 2019
Summary: The Quality Control Scientist will provide oversight of contract analytical labs and manufacturers. This includes, review of analytical data from release and stability studies and review of method validation protocols and reports. The candidate should have a strong understanding of cGMPs and relevant ICH and FDA regulatory guidelines. Prior hand-on experience working in a QC lab and with root cause analysis for investigations is required. This position will interact and work closely with cross-functional teams, including, manufacturing, quality assurance and regulatory. Responsibilities: Review analytical data packages generated during GMP release/stability testing of drug substance and drug product at the contract manufacturing sites. Assist in investigations and formulate a plan to identify/confirm root cause for anomalous results. Write and/or review method validation and transfer protocols and reports. Write and/or review protocols and reports related to stability studies as well as prepare tables summarizing results from stability studies. Establish a system for tracking and trending release and stability data for batch analysis and shelf life establishment. Initiate change control for internal specifications and regulatory documents. Evaluate and perform risk assessment for change control documents provided by the contract manufacturing sites Establish a reference standard program for drug substance, impurities and degradants. Experience and Skills: B.S. or M.S in Analytical Chemistry or related scientific disciplines with 5+ years of experience in analytical development with minimum of 3+ years of experience in quality control. Prior experience in interacting with contract labs and manufacturing sites is a plus. Hands-on experience with validation and transfer in support of pharmaceutical manufacturing. Proficiency in performing root cause analysis for investigation. Experience with iStability software is a plus Detail oriented with exceptional organizational skills. Excellent written and verbal communication skills.
Apex Life Sciences San Carlos, CA, USA
Jun 14, 2019
Position Summary : Supervisor, Incoming Document Control is responsible for the management of the document control process and controlled documents. Assist employees with recommendations regarding the release, structure and change of all controlled documentation. Primary Responsibilities : Manages the Document Control team including setting daily priorities; provides feedback to management on individual performance; ensures Document Control personnel have trained to required procedures Responsible for ensuring proper validation performed for the document management system (new software systems, updates, changes to workflows, etc.) Responsible for the development and maintenance of document templates Responsible for ensuring the document approval matrix is updated as needed Ensures annual reviews of controlled documents are performed as required Ensures maintenance of a computer database of all filed documentation that ensures fast retrieval of documents via company intranet website Ensures that historical files for Design History File (DHF), Device Master Records (DMR), Device History Records (DHR), Design Review, Validations, SOP?s, and other quality system documents are maintained. Manage archival activities for controlled documents and validation files to meet requirements of CLIA/CAP, QSR 820, ISO 13485, and State Standards. Assists with the maintenance of company training records. Performs duties of Document Control Coordinator as needed Other duties as assigned Qualifications : Bachelor?s degree or equivalent 3 plus years? experience with electronic document management systems 2 plus years of supervising teams Experience in a regulated environment (CLIA, FDA, ISO) Knowledge, Skills, and Abilities: Computer skills (MS Word, Excel, PowerPoint, etc.) Good writing and communication skills Independent worker, a self-starter with strong organizational and planning skills Ability to work with others, manage small projects, mentor others Knowledge of CLIA, FDA, and/or ISO 13485 Good Documentation practices
Apex Life Sciences South San Francisco, CA, USA
Jun 13, 2019
Responsibilities: Primary responsibilities include, but are not limited to: ? Production, purification and characterization of recombinant proteins using mammalian and E. coli expression systems: Purify antibodies using variety of systems (protein A, ion exchange, size exclusion, etc.) Analyze antibodies using standard protein characterization methods (SDS-PAGE/CE-SDS, SEC-MALS etc.) and endotoxin testing Analyze and present research data in team meetings as well as company-wide meetings Troubleshoot and optimize assays through data interpretation, identification of novel or alternate procedures and techniques Perform experiments with strong attention to detail and documentation Ability to work in a cross- functional team environment, and ability to easily adapt to changing priorities Requirements: BS degree with 5+ years of industry experience or MS degree with 2+ years of industry experience. The degree should be in Biochemistry, Molecular or Cell Biology, or similar field Experience in generation and characterization of proteins is required and antibodies is preferred Strong expertise in protein purification and characterization Experience in standard protein analytical techniques including electrophoresis, Western Blot, ELISAs, Endotoxin assays, HPLC, UV-Vis spectrophotometry Motivation to learn and use new and emerging techniques for mammalian cell culture, protein production, and flow cytometry Experience and knowledge in molecular biology and expression is a plus Ability to work independently, multi-task and meet deadlines in a fast-paced environment Highly motivated, organized and disciplined record keeping Excellent verbal and written communication skills Proven ability to learn, adapt and develop in an evolving work environment Committed to the values of integrity, scientific rigor and transparency Strong desire to work in a dynamic start-up environment is essential Current US work authorization required
Apex Life Sciences Milpitas, CA 95035, USA
Jun 13, 2019
Full time
Our Client, a bay area leader in stem cell research and specialty genome services is looking for a motivated microinjection specialist. This position is responsible for the animal model division, conducting transgenic animal production through microinjection of DNA/RNA/protein into pronuclear stage embryos or making chimeric animals with injection of targeted ESCs into morula/blastocysts. Skills and Experience Bachelor degree in Biological Sciences or Animal Science. Master degree in the related field preferred. Strong understanding of mammalian genetics. Proficient in transgenic production including rodent handling, sampling, microinjection, embryo transfer, IVF, and gamete/embryo cryopreservation. Minimum of one-year of microinjection experience, such as a weekly injection in an institutional transgenic core. Industry experience preferred. Extensive experience with animal survival surgery. Familiar with general lab operations such as pipetting, centrifuge, and biohazardous disposal etc. Strong organizational and documentation skills Effective verbal and written communication skills. Team player. Proficient at MS Office. Duties and Responsibilities Responsible for daily projects running with animal superovulation, embryo harvesting, microinjection, and embryo transfer to pseudo pregnant recipients. Carry out IVF, cryopreservation, and associated procedures for R&D and service projects. Assist with animal colony management including tracking animal pregnancy, wean, and setting up breeding. Organize and maintain laboratory notebooks and records including methods, procedures, protocols, reports, samples log and storage, and data storage. Work according to safety regulations and facility protocols. Support other departments as needed.
Apex Life Sciences San Francisco, CA, USA
Jun 13, 2019
The Senior Scientist, Analytical Development will be responsible for developing analytical techniques to support drug substance and drug product formulation development activities. Responsibilities: Develop analytical techniques to support drug substance process and drug product formulation development activities Manage analytical method development to support characterization of drug substance and drug products Apply scientific principles in selecting appropriate techniques for development of sensitive and robust methods Troubleshoot analytical methods, hardware and software issues arising at CROs/CMOs Research new techniques and recommend alternative approaches and potential solutions to analytical issues Write analytical test methods, protocols and reports as part of analytical transfers to CROs/CMOs for GMP testing Contribute to authoring of CMC sections to support regulatory filings Serve as an analytical subject matter expert within department and cross-functional areas Qualifications: Ph.D in analytical chemistry or related disciplines, with at least 5 years relevant experience in pharmaceutical industry Skills, Knowledge & Abilities: Extensive knowledge and hands-on experience on chromatographic and spectroscopic techniques (e.g. GC, HPLC, MS, UV/Vis) Knowledge of techniques required for physicochemical characterization of drug substance (e.g., particle size, TGA, DVS, DSC etc.) Experience with analytical method validations and transfers in regulated environments is required Experience with development and validation of methods for bioassay to determine potency is a plus Attention to detail and excellent analytical skills as applied to data review and investigations Passion for learning, creating, relating, communicating, and leading cross functional teams Excellent verbal and written communication skills Experience in a start-up environment preferred Must be pro-active team player, flexible, and open to change
Apex Life Sciences Carlsbad, CA, USA
Jun 13, 2019
Our client, a leader in pharmaceutical development, is seeking a research associate to join their Analytical Development and QC team. SKILLS: HPLC is most important, GMP is nice to have but not critical 2+ years industry required plus BS or BS/MS degree No PhD candidates RESPONSIBILITIES: Quality Control testing of in-process samples, drug substances and drug products in a GMP environment. Compile and review data for compliance to specifications and test procedures. Conduct of analytical investigations and the validation of analytical methods. Analytical testing of preclinical drug products in accordance with GLP guidelines. Revise and update standard operating procedures as required. Other duties as assigned. REQUIREMENTS: B.S. degree in chemistry or a related field. At least 1 year experience in Quality Control testing and proficient with GMPs. Enjoy working in the laboratory. Ability to work as part of a team and possess an excellent work ethic. Excellent problem solving, written and verbal communication skills. Experience in HPLC, GC and other analytical techniques. Working knowledge of mass spectrometry is desirable.
Apex Life Sciences Petaluma, CA, USA
Jun 13, 2019
We are seeking a QC Technician for a growing biotechnology company in the North Bay. If you have any quality or manufacturing experience please apply! Position Summary: The Quality Control Technician focuses on the performance of analytical testing activities within the QC Chemistry lab. They are responsible for testing intermediate and finished chemical products, analyzing the results of Quality Control testing and comparing results to established specification and customer requirements. In addition, they perform testing and/or review of incoming goods. Areas of Responsibility: Completing analytical Quality Control activities for chemical products in accordance with established procedures. Ensuring products tested adhere to established specifications and customer requirements for product release. Recommending product disposition and updating records associated with chemical products and incoming goods for review by QC management and Quality Assurance. Operating and maintaining standard equipment within the QC Chemistry laboratory (e.g. DNA synthesizers, HPLCs, spectrophotometers, IR, pH meters, Karl Fisher apparatus and Mass Spectrometers). Performing general laboratory maintenance and upkeep activities (e.g. loading buffers onto instruments, cleaning of the laboratory, etc.). Labeling products and incoming goods with an appropriate status label after product disposition (e.g. Approved, Rejected, etc). Interacting directly with the Manager of QC Chemistry to understand testing prioritization and obtain daily assignments. Performing standard laboratory operations, including but not limited to: dispensing chemicals, performing volumetric and gravimetric measurements, performing dilutions and preparing solutions for use in the QC Chemistry lab. Assisting in verifying and documenting Quality Control activities and procedures. May be called upon to draft or revise documentation associated with the Chemical QC process. Other duties, as assigned. Other Skills and Abilities: Self-motivated with the ability to function as a team player as well as work independently with moderate supervision. Able to multi-task work in a fast paced environment. Strong communication and problem solving abilities Some instrumentation (e.g. HPLC, IR, MS) experience or knowledge preferred. Education/Experience : BA or BS in Chemistry, Biochemistry, Analytical chemistry, or a related scientific discipline, or equivalent industry experience.
Apex Life Sciences South San Francisco, CA, USA
Jun 13, 2019
Senior Chemist Position Summary Stratacuity is a stealth-mode therapeutics development company pioneering a novel synthetic gene editing technology to treat and cure patients with devastating rare diseases. We seek a motivated and collaborative chemist to join our team. Candidates should have a Bachelor?s degree in organic chemistry with minimum of 4 years of industry experience (or minimum 2 years of experience in case of master?s degree in organic chemistry) in the field of organic or peptide synthesis. The successful candidate will be part of a dynamic and rewarding work environment where the abilities to effectively communicate and function in a team environment will be essential for success. Responsibilities Successfully prepare, purify and characterize peptide nucleic acid oligomers for Stratacuity?s research efforts toward therapeutics development for rare diseases using gene editing technology Maintain PNA monomer and oligomer inventory and Preparing PNA aliquots for delivery to different groups for research purpose Labelling of PNA probes via solution and solid phase methodologies Use and maintain the team's peptide synthesizers, HPLCs, Q-TOF and other instruments for synthesis workflow Development, submission, and maintenance QC data on files as well as on internal database Planning, execution, and documentation of work under the guidance of the lead chemist Independent work on projects and presentation in team meetings Essential Qualifications Bachelor?s degree with 4 years of industrial experience respectively in the field of organic or peptide synthesis Hands on experience in the HPLC analysis and purification Excellent communication and record keeping skills Ability to multitask, able to work in a team and readily adapts to changing priorities Preferred Qualifications Master?s degree in Chemistry with minimum 2 years of industrial experience respectively in the field of organic or peptide synthesis experience using automated peptide synthesis instrumentation Experience with LC-MS, especially LC coupled with Q-TOF Hands on experience on preparative scale purification of peptides or oligos
Apex Life Sciences San Diego, CA, USA
Jun 12, 2019
As a key member of the Analytical Science team, the Sr. Scientist is responsible for executing analytical and biochemical characterization activities for biotherapeutic protein product development, including assay development, assay qualification, and product characterization. This position must effectively communicate timelines and issues to ensure successful manufacturing, product testing/release and data package for regulatory filings. Individual technical issue management and cross functional communication are key position attributes. The candidate will work in a team environment, collaborating with various departments to ensure that manufacturing processes are properly characterized to support process transfer, achieve project goals, and timelines. The ideal candidate will have expertise with HPLC and various analytical separation techniques. ESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES ? Serve as Analytical Biochemistry (AB) subject matter expert in the development/ commercialization of recombinant proteins that requires knowledge and application of analytical technologies involving primarily HPLC separations, icIEF, CE-SDS, SDS-PAGE, Western blots, UV-Vis spectrophotometry, and other analytical protein characterization methods. ? Responsible for developing method robustness and other analytical parameters prior to analytical method Tech Transfer to QC CMO for validation. ? Facilitate and lead method transfers between CMO and/or partner. ? Partner with a diverse team of Process Development/ Characterization Scientists in USP, DSP and Analytical Biochemistry that support the advancement of a broad portfolio of products. ? Provides expertise, guidance, and feedback on protein analytical results so as to direct effective purification development and product/process control strategies ? Keeps current in analytical method development including literature and technology development and regulatory driven activities ? Author/Review detailed analytical reports and provides direct input/data/statistical analysis to support data package for regulatory submission(s). ? Interface with contract manufacturing or research organizations (CMOs/CROs) in the execution of analytical method transfer, testing, and release and stability studies. ? Assembles and delivers CMC supporting regulatory documentation required to rationalize process analytical, characterization, and release specifications ? With minimal supervision, generates and delivers concise/clear technical presentations to senior management ? Other duties as assigned or required QUALIFICATIONS A minimum of a Bachelor's degree in Analytical Chemistry/Biochemistry/Biochemical Engineering with biosimilar and/or biologics experience required ? BS in Biology/Analytical Chemistry/Biochemistry/Biochemical Engineering or related field ? BS 5 years of relevant experience w/a minimum of 7 years of industry experience ? or MS 3 years of relevant experience w/a minimum of 3 years of industry experience ? or PhD 6 to 12 months of relevant industry experience ? Ability to travel up to 10% (US and Internationally) ? Fluent in practical application of PC's, Microsoft project, Word, Excel, Power point and experience to include data analyses, statistical analysis (JMP), method transfers and comparability studies ? Experience in developing and qualifying analytical methods, primarily HPLC separations ? Scientific understanding of current analytical technologies, as well as the ability to explore and develop novel approaches to further advance innovative analytical methodologies ? Proven working knowledge and understanding of GxP (GLP, cGMP, GCP and ISO9000) environments and regulations required ? Ability to work flexible work schedules ? Analyzes reports, metrics and results as required; provides SME and strategic guidance based on findings ? Excellent verbal and written communication skills, an innovative approach to problem-solving, an integrated view of business/scientific issues, and a strong work ethic ? Possesses and demonstrates exceptional research and resource utilization skills as well as practical problem solving capabilities ? Proven ability to work in a lean organization and creatively tackle problems using colleague networks and publicly available solutions; work independently and successfully in a matrix environment; and prioritize and manage multiple tasks simultaneously ? Other duties as assigned or required Supplemental Experience (Strong Plus) ? Experience working in a biosimilars drug-development organization highly preferred ? Experience with the full product lifecycle of a biopharmaceutical product (i.e. Phases 1 4) highly preferred
Apex Life Sciences San Diego, CA, USA
Jun 12, 2019
Our client is currently focused on utilizing its proprietary E-CEL technology as a direct therapeutic product for improving Hematopoietic Stem Cell Transplants (HSCTs), as well as offering a novel therapy for the regeneration of damaged tissues resulting from both acute and chronic disease. Research Scientist, In Vivo Research & Engineered Cell Biology Position Role & Responsibilities: Conduct pre-clinical in vivo studies, some requiring microsurgery, which test our pre-clinical engineered cell product candidates Analyze data collected from in vivo studies performed Participate or lead in design of in vivo studies Conduct and analyze 2-D and 3-D engineered cell culture and assay experiments relevant to engineered cell product candidates Works collaboratively with fellow AB team members, especially with the AB Research Team and the AB Project Management Team Education/Requirements: Master?s degree or PhD in cell biology, molecular biology, biochemistry, immunology or related field and 5 or more years post-graduate hands-on laboratory experience (post-doc or industry experience) covering both in vitro and in vivo work. Enjoys a fast-paced environment where data-based changes are a constant and where proactive ?can do? attitude, sense of urgency and friendly personalities are prized. A track record of the ability to learn new in vivo surgical and modelling techniques is essential Possesses skills related to wet-lab cell-therapy translational research Various cell culture techniques, cell sorting, flow cytometry, qPCR, fluorescent microscopy, antibody assays, intra-cellular signaling detection). A successful candidate must have extensive hands-on experience in performing in-vivo animal modelling work for various potential indications. Previous experience with the following in vivo procedures: Tissue extraction and dissection, IV injection (tailvein, jugular, retro-orbital) and surgical proficiency in murine models (not limited to a specific area: e.g. intratracheal administration, partial hepatectomy, partial pneumonectomy, vascular ligation and/or thrombosis, gastrointestinal and/or vascular anastamoses, etc) Additional Desired Skills and Knowledge. Applicants with experience in various micro-surgical procedures in murine models. The applicant?s ability to not only perform such surgical procedures, but also demonstrate knowledge and experience in designing such in vivo experiments would be highly regarded. Applicants with expertise in organ regeneration modelling related to inflammatory and autoimmune disease and injuries would also be preferred. Preference for candidates with experience in the fields of tissue regeneration and/or microvascular biology and vascular niches. Demonstrated expertise in translational in vivo cellular biology involving research and/or product development of cell therapy product is highly desired.
Apex Life Sciences Novato, CA, USA
Jun 10, 2019
Full time
Position Summary: This role is responsible for administrative and project based tasks within the Quality Assurance department. The Quality Assurance Associate role is pivotal in the daily functions of the Quality operation within a growing organization and meticulous attention to detail is a key to success in this role. The Quality Assurance Associate is primarily responsible for the Batch Record Review and Document Control processes at Stratacuity. This position is a full-time, non-exempt role that reports to Quality Management. Areas of Responsibility : Review of batch production records for completeness and release Review of analytical records and any supporting documentation to ensure compliance with cGMPs and LGC Biosearch policies and procedures. Be well versed in the requirements of ISO 9001, ISO 13485, 21 CFR 820 and other applicable regulations. Perform routine document control activities including creation and/or revision, processing, routing and review. Work with various departments to set up appropriate documentation to improve efficiency and accuracy. Assists in performing QC data review for batch record in-process and final QC approval. Assist with internal Quality audits of internal departments, as necessary. Assisting Quality Management with various projects, including but not limited to the trending of Quality Objective data and CAPA maintenance. May be called upon to assist with the Supplier Qualification program. Provide guidance and train others on Quality System and Quality Assurance procedures. Perform additional tasks, as assigned Experience with Batch Record Review, Product Disposition and Document Control. Familiarity with ISO 9001:2008, ISO 13485:2003 and 21 CFR 820. Excellent people, verbal, and communication skills. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Must have solid teamwork skills to interface with engineers, chemists, technicians and analysts to ensure smooth laboratory and plant operations. Self-motivated individual who can work in a multi-disciplinary team. Good troubleshooting, communications, and teamwork. Education/Experience: Bachelor's degree
Apex Life Sciences South San Francisco, CA, USA
Jun 10, 2019
Full time
Responsibilities: Primary responsibilities include, but are not limited to: • Production, purification and characterization of recombinant proteins using mammalian and E. coli expression systems: Purify antibodies using variety of systems (protein A, ion exchange, size exclusion, etc.) Analyze antibodies using standard protein characterization methods (SDS-PAGE/CE-SDS, SEC-MALS etc.) and endotoxin testing Analyze and present research data in team meetings as well as company-wide meetings Troubleshoot and optimize assays through data interpretation, identification of novel or alternate procedures and techniques Perform experiments with strong attention to detail and documentation Ability to work in a cross- functional team environment, and ability to easily adapt to changing priorities Requirements: BS degree with 5+ years of industry experience or MS degree with 2+ years of industry experience. The degree should be in Biochemistry, Molecular or Cell Biology, or similar field Experience in generation and characterization of proteins is required and antibodies is preferred Strong expertise in protein purification and characterization Experience in standard protein analytical techniques including electrophoresis, Western Blot, ELISAs, Endotoxin assays, HPLC, UV-Vis spectrophotometry Motivation to learn and use new and emerging techniques for mammalian cell culture, protein production, and flow cytometry Experience and knowledge in molecular biology and expression is a plus Ability to work independently, multi-task and meet deadlines in a fast-paced environment Highly motivated, organized and disciplined record keeping Excellent verbal and written communication skills Proven ability to learn, adapt and develop in an evolving work environment Committed to the values of integrity, scientific rigor and transparency Strong desire to work in a dynamic start-up environment is essential Current US work authorization required
Apex Life Sciences Los Angeles, CA, USA
Jun 09, 2019
Full time
Our client, a pharmaceutical company in the LA area is looking for a Compliance Manager to join their team! Summary: The Compliance Manager implements, maintains and continually improves the compliance function at the company. The Compliance Manager provides substantial input and oversight into a variety of projects and processes to insure adherence with all laws, regulations and contractual obligations that apply. Acts as an advisor on custom software development projects and Commercial Off-The-Shelf Software (COTS) to ensure regulatory compliance. Collaborates with Quality Assurance and other departments as advisor on compliance issues for resolution. This position serves as the main interface with sponsor and regulatory auditors/inspectors. Responsibilities: Responsible for staffing, scheduling, interviewing and hiring, evaluating work performance, counseling, discipline, and termination. Participates in addressing employee grievances. Provides daily direction, communication, training, and oversight to the team to ensure efficient productivity. Monitors and negotiates the scope of the compliance work and commitments. Monitors workflow to ensure adequate productivity and timely completion of projects. Notifies appropriate personnel of delays or problems which may affect timelines and/or deadlines. Oversee study assignments and resourcing in conjunction with appropriate stakeholders. Aids in the development of training programs for existing staff and new hires. Mentors team personnel, including but not limited to: Establishing timelines/expectations for training of individuals, and monitoring progress. Identifying training and learning opportunities for compliance team (e.g. technical training, educational programs, quality improvement projects), and involving or delegating to direct reports accordingly. Inviting team members to participate in meetings or teleconferences, both internal and external (e.g. setting up a study) Providing feedback for circumstances as observed on a day-to-day basis Including team members in quality improvement and/or other ad hoc projects Knowledge and information sharing Oversees and provides direction for regulatory compliance strategy and activities Stay up-to-date with the latest developments in regulatory compliance, in particular as relates to the company. Maintains an expert level understanding of any and all laws, regulations and contractual obligations that apply to the company. Act as the primary point of contact for external regulatory compliance audits from sponsors and regulatory agencies and is responsible for related inspection readiness activities at company. Prepare responses to external compliance audit observations, and works in coordination and collaboration with impacted stakeholders to address audit findings and in accordance with internal procedures/policies. Qualifications: Bachelor's degree required. Combined education and experience may be used as substitute for minimum education. Professional training in Clinical Trial Operations; FDA Regulations and ICH/GCP Guidelines for clinical research preferred. Certified Regulatory Compliance Manager (CRCM) preferred. CCRP or similar clinical research certification beneficial. 5 years of progressive management experience. Prior supervisory experience preferred Strong familiarity with CFR Title 21, ICH GCP, and GDPR Experience with ISO9001 beneficial 5+ years developing and implementing compliance programs in a laboratory or healthcare environment. Project management experience preferred Minimum of 4 years of progressively responsible professional experience required. Experience in multi-center clinical trials required. Familiarity with process and quality improvement principles (e.g. Six Sigma) preferred. 5+ years working in a clinical research environment Familiarity with software development and the software development lifecycle Expert level in standard Microsoft Office programs
Apex Life Sciences San Diego, CA, USA
Jun 09, 2019
Full time
As a key member of the Analytical Science team, the Sr. Scientist is responsible for executing analytical and biochemical characterization activities for biotherapeutic protein product development, including assay development, assay qualification, and product characterization. This position must effectively communicate timelines and issues to ensure successful manufacturing, product testing/release and data package for regulatory filings. Individual technical issue management and cross functional communication are key position attributes. The candidate will work in a team environment, collaborating with various departments to ensure that manufacturing processes are properly characterized to support process transfer, achieve project goals, and timelines. The ideal candidate will have expertise with HPLC and various analytical separation techniques. ESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES • Serve as Analytical Biochemistry (AB) subject matter expert in the development/ commercialization of recombinant proteins that requires knowledge and application of analytical technologies involving primarily HPLC separations, icIEF, CE-SDS, SDS-PAGE, Western blots, UV-Vis spectrophotometry, and other analytical protein characterization methods. • Responsible for developing method robustness and other analytical parameters prior to analytical method Tech Transfer to QC CMO for validation. • Facilitate and lead method transfers between CMO and/or partner. • Partner with a diverse team of Process Development/ Characterization Scientists in USP, DSP and Analytical Biochemistry that support the advancement of a broad portfolio of products. • Provides expertise, guidance, and feedback on protein analytical results so as to direct effective purification development and product/process control strategies • Keeps current in analytical method development including literature and technology development and regulatory driven activities • Author/Review detailed analytical reports and provides direct input/data/statistical analysis to support data package for regulatory submission(s). • Interface with contract manufacturing or research organizations (CMOs/CROs) in the execution of analytical method transfer, testing, and release and stability studies. • Assembles and delivers CMC supporting regulatory documentation required to rationalize process analytical, characterization, and release specifications • With minimal supervision, generates and delivers concise/clear technical presentations to senior management • Other duties as assigned or required QUALIFICATIONS A minimum of a Bachelor's degree in Analytical Chemistry/Biochemistry/Biochemical Engineering with biosimilar and/or biologics experience required • BS in Biology/Analytical Chemistry/Biochemistry/Biochemical Engineering or related field • BS 5 years of relevant experience w/a minimum of 7 years of industry experience • or MS 3 years of relevant experience w/a minimum of 3 years of industry experience • or PhD 6 to 12 months of relevant industry experience • Ability to travel up to 10% (US and Internationally) • Fluent in practical application of PC's, Microsoft project, Word, Excel, Power point and experience to include data analyses, statistical analysis (JMP), method transfers and comparability studies • Experience in developing and qualifying analytical methods, primarily HPLC separations • Scientific understanding of current analytical technologies, as well as the ability to explore and develop novel approaches to further advance innovative analytical methodologies • Proven working knowledge and understanding of GxP (GLP, cGMP, GCP and ISO9000) environments and regulations required • Ability to work flexible work schedules • Analyzes reports, metrics and results as required; provides SME and strategic guidance based on findings • Excellent verbal and written communication skills, an innovative approach to problem-solving, an integrated view of business/scientific issues, and a strong work ethic • Possesses and demonstrates exceptional research and resource utilization skills as well as practical problem solving capabilities • Proven ability to work in a lean organization and creatively tackle problems using colleague networks and publicly available solutions; work independently and successfully in a matrix environment; and prioritize and manage multiple tasks simultaneously • Other duties as assigned or required Supplemental Experience (Strong Plus) • Experience working in a biosimilars drug-development organization highly preferred • Experience with the full product lifecycle of a biopharmaceutical product (i.e. Phases 1 4) highly preferred
Apex Life Sciences Milpitas, CA 95035, USA
Jun 08, 2019
Full time
Senior Research Associate, iPSCs group iPSC AND GENE EDITING EXPERIENCE IS REQUIRED Our Client, a bay area leader in stem cell research and specialty genome services is looking for a motivated senior research associate to join their growing Life Sciences department. This is a hands-on lab-based role in iPSCs group with a focus on iPSCs differentiation and engineering using gene editing technologies. Skills and Experience BS degree in biological sciences such as cell biology, developmental biology, molecular biology, genetics or a related field. MS degree preferred. 2-4 years' experience with iPSCs and/or stem cell culture systems, cell transfection, FACS etc. Hands-on experience with iPSCs generation and differentiation. Knowledge and hand-on experience with CRISPR gene editing technology is a plus. Good oral and written communication skills and organizational skills. Proficient at MS Office Duties and Responsibilities Work closely with a multi-function team to deliver engineered iPSCs cell lines and a variety of other cell types. Work on gene editing projects in iPSCs/stem cells, preparing reagents, performing cell culture and cell-based assays. Work on iPSCs generation, differentiation and characterization. Apply scientific knowledge, critical thinking, and problem-solving abilities to troubleshoot and refine methods and assays Interpret genotyping data from Sanger sequencing and Nextgen sequencing Follow established protocols and SOPs Maintains good lab records and effectively update results and project status in an informatics system. Participates in group meeting and present technical data