Associate/ Sr. Associate, Drug Substance Contract ManufacturingLocation Novato, California Apply
The Associate/Sr. Associate, Drug Substance Contract Manufacturing is responsible for project management of pre-clinical and clinical synthetic drug substance manufacturing and related activities (i.e., coordinating logistics and quality event documentation) at contract manufacturing organization (CMO) sites. He/she will be the principal contact for CMOs and will be empowered to make tactical decisions to ensure that synthetic drug substance manufacturing activities are performed in accordance with best practices, encompassing regulatory, budget, and quality considerations.
- Monitor pre-clinical and clinical production efforts at contract manufacturers.
- Coordinate logistics, CMC documentation (batch records, analytical methods, and specifications), and oversee metrics for financial and quality requirements.
- Ensure that representatives from all relevant functional areas (including but not limited to Quality Assurance, Formulation, Analytical Chemistry, Quality Control, and Regulatory Affairs) are engaged in management and assessment of CMO activities.
- Maintain IT resources such as Sharepoint/O365 and LiveLink to ensure that comprehensive process development and quality system documentation is current and available to support regulatory filings.
- Author and manage quality documents (deviations, change requests, etc.) in Trackwise and ensure current status, aligned with manufacturing activities.
- With the Corporate Global Compliance and Quality departments, ensure that the CMO facilities are compliant with GMPs and lead efforts to ensure CAPA follow-up when required.
- Manage legal contracts (MNDAs, MSAs, SOWs, etc.) with CMOs, ensuring consistent requirements across sites and programs.
- Customarily and regularly exercises discretion and independent judgment in the
performance of the duties described above.
- Other duties as assigned.
- Bachelors degree in science with 2 - 6 years of GMP manufacturing experience.
- Chemistry/Biochemistry background preferred.
Working knowledge of GMP manufacturing operations.
Working knowledge of GMP Quality systems and document management (e.g., Change Control, Deviation, CAPA)
Process development or technology transfer experience preferred.
Excellent organizational and IT skills.
Excellent written and verbal communication skills.
Ability to influence through negotiation.
Work EnvironmentTravel: Approx. 10%