Responsible for oversight and management of Silverback’s CMC functions and Contract Manufacturing Organizations (CMOs) to ensure successful execution of process development, clinical manufacturing, and supply. Directs, coordinates, and oversees all related technical and operational activities. Serves as key interface between internal functions and the CMO. Scales build of internal CMC functional area in alignment with organizational growth.
Essential Duties and Responsibilities:
- Manage contractors, consultants, suppliers, and all outsourced CMC activities required to enable clinical material supply. Ensure the selection of appropriate vendors and oversee technical services to ensure competence and data integrity.
- Plan and build the CMC functional area as appropriate to support ongoing organizational needs. Recruit, manage, and lead internal team in alignment with scaled organizational growth. Provide guidance, mentoring, and development of staff; ensure team has appropriate skills, capabilities, equipment, and resources to meet current and future business needs.
- Ensure all development, stability, and manufacturing activities relating to drug substance and drug product are completed in accordance with quality and regulatory expectations to support relevant regulatory submissions and meet clinical supply requirements.
- Serve as technical expert on CMC matters. Troubleshoot issues and solve problems. Stay abreast of current technologies and approaches. Represent CMC on cross-functional project teams, working in close collaboration with other functional area team members.
- Serve as primary point of contact for the CMOs to support batch planning and manufacture, batch record review, deviation investigation, release and logistics. Serve as Person-In-Plant when needed and provide on-site oversight at CMOs during critical activities.
- Plan, negotiate, and manage CMC and CMO-related contracts, budgets, forecasts, and timelines.
- Develop and maintain mutually beneficial, long-term business relationships with CMOs.
- Participate in CMC-Regulatory strategy development, providing input to and support for the compilation of regulatory submissions. Represent CMC in meetings with regulatory agencies.
- Provide CMC information and manufacturing plans/updates to the management team, the Board of Directors, and business partners, as required.
- Perform other duties as assigned.
PhD degree in chemistry, biochemistry, engineering, or similar technical area.
15+ years of experience in the biotech/pharmaceutical industry in the areas of process, analytical, or formulation development and/or manufacturing. Repeated, demonstrated previous success in CMO management. Technical experience with a range of therapeutic modalities preferred, including biologics, small molecules, and antibody-drug conjugates. Solid understanding of FDA / EMEA / ICH / cGMP requirements. Effective communication, negotiation, collaboration, and leadership skills. Prior start-up experience is desirable. Up to 15% domestic and international travel may be required.
Silverback Therapeutics is a privately held biotechnology company advancing a pipeline of first-in-class therapies targeting fundamental disease pathways that are systemically delivered but locally active. Founded in 2016, Silverback is funded by OrbiMed, Celgene Corporation, and Alexandria Venture Investments. The company is headquartered in Seattle, Washington. For more information, please visit www.silverbacktx.com. We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options. Qualified candidates should forward their resumes to firstname.lastname@example.org. We are an equal opportunity employer.