Position Summary:
The Senior Project Manager, Technical Operations (CMC) is responsible for driving the execution of Technical Operations strategies that support product development, clinical manufacturing, commercial launch planning, logistic, and lifecycle management. Partners with Quality, Regulatory Affairs, Supply Chain, and Clinical Supply to ensure alignment, risk management, and achievement of program milestones.
Responsibilities:
- Execute CMC strategies aligned with corporate objectives for biologics program(s).
- Develop and maintain integrated project plans, timelines, and resource forecasts.
- Communicate project status, risks, and opportunities; improve operational efficiency.
- Facilitate team meetings; prepare agendas and meeting minutes; ensure deliverable accountability.
- Monitor progress; proactively identify, assess, and mitigate risks.
- Coordinate CMC initiatives and cross-functional readiness for technical documentation, regulatory commitments, and other CMC deliverables.
- Align with stakeholders to support production schedules, supply planning, and inventory management for uninterrupted product availability.
Education/Experience Requirements:
- Bachelorβs degree in Life Sciences/Chemistry/Pharmaceutical Sciences/Biology/Biochemistry/Chemical Engineering or related field (equivalent education/experience considered).
- MS/MBA/PhD/PharmD or other advanced degree preferred.
- 7+ years in biotechnology/pharmaceutical development/manufacturing/technical operations.
- 4+ years project management experience supporting CMC/Technical Operations/Manufacturing/Product Development.
- Direct experience with biologic drug products (CMC development, manufacturing, lifecycle management).
- Experience managing complex cross-functional projects through clinical development and commercialization.
- BLA submissions and post-approval commitments preferred.
- GMP regulations, quality systems, biologics manufacturing operations; process validation and technology transfer knowledge.
Additional Skills/Experience:
- Strong project planning, risk, and stakeholder management; excellent communication and executive presentation.
- Proficiency with project tools (e.g., Smartsheet, MS Project); PMP preferred.
- Ability to adapt to plan changes; strong collaboration/attention to detail.
- Travel 10% domestically/internationally; onsite presence in San Diego required; not 100% remote.
Benefits:
- Premium health and work-life/well-being offerings, wellness and support programs, life insurance, disability, retirement plans with employer match, and generous paid time off.
Compensation:
- Target base pay range: $132,000.00β$172,000.00.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.