Execute CMC strategies aligned with corporate objectives for biologics program(s).
Develop and maintain integrated project plans, timelines, and resource forecasts.
Ensure effective communication of project status, risks, and opportunities; improve operational efficiency.
Facilitate team meetings, prepare agenda, publish meeting minutes, and ensure accountability for deliverables.
Monitor project progress and proactively identify, assess, and mitigate risks.
Coordinate CMC initiatives and activities, and partner with cross-functional teams to ensure readiness and timely delivery of technical documentation and regulatory commitments, and other CMC deliverables.
Align with internal and external stakeholders to support production schedules, supply planning, and inventory management to ensure uninterrupted product availability.
Additional duties assigned as needed.
Education/Experience Requirements
Bachelor’s degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, or a related discipline required. Equivalent combination of education and applicable job experience may be considered
MS, MBA, PhD, PharmD, or other advanced degree in a related discipline preferred
7+ years of relevant experience in biotechnology, pharmaceutical development, manufacturing, or technical operations
4+ years of project management experience supporting CMC, Technical Operations, Manufacturing, or Product Development programs
Direct experience supporting biologic drug products, including CMC development, manufacturing, and lifecycle management activities
Demonstrated experience managing complex cross-functional projects through clinical development and commercialization
Experience supporting Biologics License Application (BLA) submissions and post-approval commitments is preferred
Familiarity with GMP regulations, quality systems, and biologics manufacturing operations
Knowledge of process validation, technology transfer, and commercial manufacturing operations for biologics
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Project Management and Information Technology
Industries
Staffing and Recruiting
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