Posted in Software 30+ days ago.
This job brought to you by eQuest
Location: Conshohocken, Pennsylvania
Position Title: Biochemistry Manager
Working Location: Pennsylvania
Employment Status: Full time
Required Experience: 6 years
Required Education: Bachelors
Travel Required: 0%
Essential functions include planning and prioritizing resource allocation in Upper Merion Biopharm quality control biochemistry laboratory to meet testing requirements for product release and stability programs. Oversee the operation of QC Biochemistry area which includes bioassay, separations and immunoassay testing areas. Responsible for training quality control analysts, transferring assays from the development group, qualifying and validating new assays and implementing assays to be used for quality control purposes to support manufacturing and marketing of the product. Other functions: conduct laboratory investigations related to product testing, compile reports in support of product filings with the regulatory agencies. Review and release of test results, and ensure full cGMP compliance in the laboratory operations. Prepare documents (IND, BLA and MAA) to support regulatory filing.
• Responsible for training quality control analysts, transfer assays from development group, qualify and validate new assays and implement assays to be used for quality control purposes to support manufacturing and commercial products.
• Work directly with other QC groups to ensure timelines are met for release, technical transfers, stability and in-process testing.
• Conduct laboratory investigations related to product testing.
• Compile reports in support of product filings with the regulatory agency.
• Review and release of test results.
• Ensure group compliance with laws, regulations, guidelines, procedures and practices governing bioassay QC testing, including departmental and corporate standard operating procedures and safety procedures
• Ensure technical and professional growth of QC analysts, encouraging excellence and continuous improvement in their performance
• Collaborate and work effectively within the Quality Control groups as well as other departments.
• Represent the quality control department and departmental functions on company projects/committees. Review, update regulatory documents (IND, EOP2, IMPD), as required.
• Good statistical analysis, analytical and trouble shooting skills and effective multi-tasking skills.
• Must have excellent technical writing skills and high attention to detail
• Knowledge in cGMP, CFR and other regulations in order to assure laboratory compliance.
• Able to seek additional tasks or non-routine functions and accomplish them with minimal supervision.
• Overcome conflicts with priorities; consult supervisor regarding major conflicts.
• Have knowledge of cell-based or analytical assays performed in a cGMP environment.
• Have knowledge of assay transfer, validation and implementation.
• Enthusiasm to identify and evaluate new assays and new technology in improving proficiency in laboratory operations. Exceptional OE skills.
• Strong organizational skills in record keeping, data analysis, and strong computer skills.
• Good verbal and written communication ability and team oriented with strong interpersonal skills.
• Have ability to plan budget for the group
• B.S. with 12+ years, M.S. with 10+ years or PhD, with 6+ years industrial experience in biopharmaceutical industry, in Biology, Biochemistry, Analytical Chemistry or a related field, particularly in the area of assessing product activities of biological products
• 5+ years of supervisory and managerial experience.
We are an Equal Opportunity Employer and do not discriminate against
any employee or applicant for employment because of race, color, sex,
age, national origin, religion, sexual orientation, gender identity,
status as a veteran, and basis of disability or any other federal,
state or local protected class.