Position: CMC Manager
Reports To: Vice President, CMC
The role in Technical Operations is responsible for supporting oncology drug substance (DS) and drug product (DP) manufacturing.
- This position is for an experienced technical operations and program manager to serve as a point of contact for DS & DP manufacturing, along with clinical labeling, packaging and supply chain management of the clinical trial material.
- The candidate must have deep and broad expertise in DS and DP manufacturing and project management of all related activities. The candidate will leverage their direct manufacturing and project management experience to ensure the phase-appropriate development is in place to properly support all aspects of drug development and manufacture.
- This is an individual and team contributor role in which the candidate provides DS, DP and clinical supply chain management expertise and manage development and manufacturing aspects of the projects. This role requires significant internal and external collaboration including the management of manufacturing activities conducted at external Contract Manufacturing Organizations (CMOs).
- As needed, the position will represent CMC during meetings involving various functions such as Clinical, Regulatory Affairs, QA/QC, Analytical Services, and R&D.
- Provide technical and project management support to the CMC processes.
- Quickly and effectively resolve complex technical issues and deviations / investigations.
- Effectively communicate complex technical issues and deliver concise presentations to internal stakeholders.
- Provide input for selecting external contractors and manage day-to-day contractor activities for respective projects.
- Create and enhance collaborative relationships internally and with personnel at CMOs.
- Understand and implement various aspects of analytical method validation and problem-solving methodologies.
- Maintain a high level of professional and technical expertise through familiarity with scientific literature.
- Oversees the interaction with CMOs to ensure successful technical transfers and is considered the subject matter expert during troubleshooting activities.
- Under the direction of VP CMC, authors/reviews quality documentation, such as protocols, validation reports, methods, technology transfer reports, and scientific investigation reports, as well as technical reports needed to support regulatory filings.
- Under the direction of VP CMC, author and/or review relevant drug substance and drug product CMC sections for global regulatory submissions (IND/CTA and NDA/MAA and annual reports) and ensure sections meet submission ready standards regarding content and format.
- Assist VP of CMC with responses to regulatory agencies
- Ensure process knowledge documents, development reports, and specifications are compliant with internal procedures and regulatory requirements.
- Assist VP of CMC in the development and implementation of departmental processes, procedures and policies.
- Maintain adherence to departmental and quality systems, such as SOP training records, deviations/investigations, CAPAs, and Change Controls.
- Actively contribute to the preparation and coordination of audits.
- Supervise / coach less experienced staff as needed.
EDUCATION, COMPETENCIES AND SKILLS:
- Requires BS degree with 10-15 yr experience, or an advanced degree (MS or PhD) in Chemistry, Chemical Engineering, Pharmacy or closely related field and 5-10 years of relevant CMC experience within the Pharmaceutical Industry.
- Experience with the pilot plant manufacturing of drug substance and drug products.
- Strong knowledge of ICH and other regulatory guidelines.
- Knowledge and experience with phase-appropriate product development and clinical supplies processes and project management.
- Experience in authoring CMC sections of IND/IMPD and NDA/MAA regulatory submissions.
- Experience working with Contract Research Laboratories and cGMP manufacturing sites.
- Proven experience with various quality systems (e.g. investigations / deviations, CAPAs, change controls, etc.).
About ORIC Pharmaceuticals
ORIC Pharmaceuticals is a privately held, clinical-stage oncology company focused on developing cancer treatments that address mechanisms of therapeutic resistance. ORIC's lead program, ORIC-101, is a potent and selective small molecule antagonist of the glucocorticoid receptor, which has been linked to treatment resistance to multiple classes of anti-cancer therapeutics across a variety of solid tumors. ORIC's pipeline also includes an orally-available small molecule inhibitor of CD73, as well as other undisclosed programs targeting mechanisms of oncology therapeutic resistance. ORIC's scientific founders are Charles Sawyers, MD, and Scott Lowe, PhD, who have long records of discovering novel targets in cancer that have led to innovative treatments. The company has assembled strong leadership and scientific teams and a board with extensive experience in drug development and financing. ORIC is funded by leading biotechnology investors and is headquartered in South San Francisco, California.