Sr. Scientist - Gene Therapy & GMP
Marin Metro Area, CA
Lead/manage efforts to perform laboratory testing of BioMarin drug products and APIs. May manage one or more direct reports.
Contribute to data review for several methods.
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).
Support/lead activities for Pre-Licensing Approval Inspection (PLI) readiness.
Support/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/CTO and review and approve out-of-specification (OOS), out-of-trend (OOT) and out-of-expectation (OOE) testing results, deviations.
Guide the transfer of analytical methods to CTOs for gene therapy based products and lead/support method optimization and trouble-shooting as needed. These methods may include HPLC, ELISA, cell-based potency and other methods.
Champion 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 managing and testing as a leader in a Quality Control function at a Senior Associate level is required.
Experience in analytical development for biologics is required; experience working on gene therapy products is preferred.
Experience with analytical systems (LIMS, laboratory control systems, stability/release systems) is required.
Functioned as audit support and/or lead audit support during previous inspections.
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 strongly preferred.
Demonstrated experience with development, optimization, qualification, and validation of ELISA or activity-based methods for potency, identity analysis for drug substance or product release is strongly preferred.
Demonstrated experience with development, optimization, 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.
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.
Previous experience in a lead role with 3-6 direct reports is required.
BS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 8-12 years professional experience).
MS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 6 8 years professional experience).
PhD in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 3 - 6 years professional experience).
The Sr. Scientist or Scientist QC is a member of the Quality Control team and is responsible for providing solid technical leadership and guidance relative to the performance, validation, optimization, development, troubleshooting, and transfer of molecular biological, biochemical and chemical evaluations for drug substance and drug product. He/she should exhibit strong cGMP knowledge and guidance for junior team members and escalate issues as needed. It is expected that he/she may lead/manage one or more reports independently while completing work assignments from semi-routine to complex in nature and delivering work product in a timely manner. 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. Demonstrated ability to work effectively in a quality control testing environment and work with external contract testing organizations (CTOs) are requirements for the position.