Senior Associate, Quality Control (QC) Viral Vector AnalyticalLocation Novato, California
Senior Associate,Quality Control (QC) Viral Vector
The Senior QC Associate is a member of the Quality Control team and is responsible for providing solid technical leadership relative to the performance, validation, optimization, development, troubleshooting, and transfer of molecular biological, biochemical and chemical evaluations for drug substance, drug product. It is expected that he/she will work independently under minimal direction while completing work assignments from semi-routine to complex in nature delivering work product on time. He/she is expected to provide strong cGMP knowledge and guidance to team members and will escalate issues as needed. The ability to recognize deviations from the accepted practice/SOPs through foundational technical expertise and compliance is a requirement. Good written and verbal communication skills are essential.
- Lead efforts to perform laboratory testing of BioMarin drug products and API’s
- Analyze, trend, and review quality control release and stability testing data of BioMarin’s pharmaceutical products at Contract Testing Laboratories (CTLs) and/or Contract Manufacturing Organizations (CMOs)
- Contribute to data review for several methods.
- May have one or more direct reports and is expected to provide cGMP knowledge and guidance to QC team members.
- Support activities for Pre-Licensing Approval Inspection (PAI) readiness
- Support or lead the preparation of phase-appropriate stability protocols and stability reports for API and drug product in accordance with regulatory requirements and as needed to support clinical trials and regulatory submissions .
- Lead investigations conducted at CMO/CTL and review and approve out-of-specification (OOS), out-of-trend (OOT) and out-of-expectation (OOE) testing results, deviations.
- Support or lead the transfer of analytical methods to CTL’s for gene therapy products. These methods may include HPLC, ELISA, and other methods. Experience running and trouble-shooting cell-based methods is highly preferred.
- Support continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).
- Work collaboratively with manufacturing/supply chain, quality assurance, regulatory, and project management to ensure timely availability of lot release, stability data, and other required analytical data.
Qualifications / Requirements:
- Relevant experience in a Quality Control function at an Associate level is required.
- Experience in analytical development for biologics is required.
- Experience with analytical systems (LIMS, laboratory control systems, stability/release systems) is required.
- Functioned as audit support during previous inspections is preferred.
- Thorough understanding of regulatory agency (FDA) requirement and international guidance (ICH) for drug substance and product under GMP is required as applied to biologics.
- Analytical development experience developing, qualifying, validating, and transfer of chromatographic methods (HPLC, SEC, CZE), spectroscopic methods (FTIR. UV), and other physical and biochemical methods to analyze biologic or protein drug substances and drug products is required.
- Demonstrated experience with development, qualification, and validation of ELISA or other immunoassays for potency, identity analysis for drug substance or product release is preferred.
- Demonstrated experience with development, qualification, and validation of tests for identity, purity, potency for API and drug product (raw materials, in-process, release) and/or excipients is required.
- Ability to effectively prioritize and deliver on tight timelines in a fast-paced environment.
- Excellent written and verbal communication skills.
- Experience in analytical data systems (Empower, LIMS)
- Accuracy and attention to detail.
- Excellent cross-functional team participation skills.
- Solid problem-solving abilities.
- Ability to be flexible with changing work needs
- Interacts with other functional leaders, project management and QC/AD team personnel
- Interacts with Contract Testing Laboratories, Contract Manufacturing Organizations, consultants and external partners
- Functioned in a role with 1-3 direct reports is preferred.
- BS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field(with 5-8 years professional experience).
- MS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 4-6 years professional experience).
- PhD in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 2-3 years professional experience).