Senior Project Manager, Technical Operations

This is a fully remote position, open to applicants in California.

📋 Description

• Implement CMC strategies that align with corporate goals for biologics program(s).

• Create and uphold integrated project plans, timelines, and resource forecasts.

• Ensure clear communication regarding project status, risks, and opportunities; enhance operational efficiency.

• Organize team meetings, prepare agendas, document meeting minutes, and guarantee accountability for deliverables.

• Track project progression and proactively identify, evaluate, and mitigate risks.

• Coordinate CMC initiatives and activities while collaborating with cross-functional teams to ensure preparedness and timely delivery of technical documentation, regulatory commitments, and other CMC outputs.

• Collaborate with internal and external stakeholders to support production schedules, supply planning, and inventory management, ensuring seamless product availability.

• Additional responsibilities assigned as necessary.

⛳️ Requirements

• A Bachelor’s degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, or a related field is required.

• An MS, MBA, PhD, PharmD, or another advanced degree in a related area is preferred.

• Over 7 years of relevant experience in biotechnology, pharmaceutical development, manufacturing, or technical operations.

• More than 4 years of project management experience in support of CMC, Technical Operations, Manufacturing, or Product Development programs.

• Direct experience with biologic drug products, encompassing CMC development, manufacturing, and lifecycle management activities.

• Proven experience in managing intricate cross-functional projects throughout clinical development and commercialization.

• Experience in supporting Biologics License Application (BLA) submissions and post-approval commitments is preferred.

• Familiarity with GMP regulations, quality systems, and biologics manufacturing processes.

• Understanding of process validation, technology transfer, and commercial manufacturing operations for biologics.

🏝️ Benefits

• Premium health coverage.

• Financial offerings.

• Work-life and well-being benefits for eligible employees and their dependents.

• Wellness and employee support programs.

• Life insurance.

• Disability coverage.

• Retirement plans with employer match.

• Generous paid time off.