Senior Manager/ Associate Director, Contract Manufacturing Organization (CMO) Management
Location: South San Francisco, CA
Position type: Full-time
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a biotechnology company focused on discovering and developing transformative protein-based medicines for patients with serious unmet medical needs. The company has an emerging portfolio of innovative products for inflammation and cancer, and currently has 3 protein therapeutics in clinical testing covering 11 indications.
- FPA008 – a monoclonal antibody targeting CSF1R in 3 disease areas involving immuno-oncology, solid tumors and inflammation
- FPA144 – a monoclonal antibody targeting FGFR2b for selected gastric cancers
- FP-1039 – An FGF ligand trap in Phase 1b for solid tumors
FivePrime also focuses on developing world-class companion diagnostic and biomarker strategies for the appropriate therapeutic settings. Five Prime’s discovery platforms can rapidly interrogate the entire extracellular proteome in medically relevant in vitro and in vivo models leading to novel targets and drug leads. Our technology has been validated by our growing pipeline and through multiple partnerships with pharmaceutical companies including GlaxoSmithKline, UCB, and Bristol-Myers Squibb across a range of therapeutic indications. FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products.
Reporting to the Executive Director of Manufacturing Sciences, this position will be responsible for managing Drug Substances and Drug Products Contract Manufacturing Organizations (CMO’s) for FivePrime’s therapeutic protein pipeline. Working with the Biopharmaceutical Development team, the candidate will be the key interface for all aspects of clinical manufacturing including CMO relationship management, planning, technical support and production oversight. This position requires broad knowledge on protein production technologies including cell culture, purification and aseptic filling processes. This role also requires administrative experiences including contract review, budget planning, invoice approvals and managing project-related timeline.
Essential Functions and Duties:
- Manage relationship with Drug Substances and Drug Products Contract Manufacturing Organizations, including coordination, communication, and technical oversight, to ensure timely delivery of quality GMP products to support clinical trials.
- Collaborate with Business Development, Legal and Procurement to review and negotiate contract terms and execution of agreements.
- Partner with internal technical teams to coordinate technology transfer, risk assessment, and readiness activities for GMP production at CMO’s.
- Partner with Process Development and Quality team to review and approve MBRs.
- Serve as primary point of contact to the CMOs to support batch manufacture, deviation investigation, release and logistics.
- Supports Person-In-Plant (PIP) and provides on-site oversight at CMO's during critical activities.
- Collaborate with CMO project manager in development project plans and schedules and ensure the tasks are executed accordingly to the agreement, cGMP requirements and regulatory commitments
- Keep up with the latest regulatory and cGMP guidance.
- Maintain awareness of state of the art manufacturing practices and monitor status of CMO capacity and provide update to the leadership team.
- B.S. or B.A. in biochemistry, chemical/biochemical engineering or related discipline required. Advanced degree preferred.
- Minimum 10 years' experience within biopharmaceutical CMC development, such as process development, cGMP production and regulatory
- Direct experience in tech transfer to CMO and oversight of GMP production is required.
- Strong technical understanding of bioprocess technologies, including cell culture and purification processes is highly desired
- Excellent organizational skills, capable of setting priorities and managing high workload
- Project management skills, experience with Microsoft Project and other reporting/tracking tools
- Strong communication skills, proven ability to build and maintain collaborative, effective internal and external relationships
- Ability to multitask and manage a variety of projects and timelines within a fast-paced team environment
- Good understanding of FDA/EMEA/ICH/cGMP guidance documents
Please upload your cover letter and resume