Project Manager
About The Position
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. Job Summary We are looking for a Project Manager to lead biologics programs across the full lifecycle, from technology transfer and process development through GMP manufacturing. This role is responsible for delivering programs on time, within scope, and within budget while ensuring compliance with regulatory standards. The Project Manager serves as the primary liaison between clients and internal cross-functional teams, driving alignment across Process Development, Manufacturing, Quality, Regulatory, MSAT, Analytical, and Supply Chain. This position is accountable for planning, execution, risk management, financial oversight, and effective communication throughout the project lifecycle.
Requirements
- Strong written and verbal communication skills with the ability to manage senior stakeholders.
- Ability to lead cross-functional teams without direct authority.
- Effective problem-solving and conflict resolution skills.
- Solid financial acumen with understanding of contracts and invoicing processes.
- Bachelor’s degree in Life Sciences, Chemistry, Biotechnology, Engineering, or a related field.
- 3–8 years of experience in biopharmaceutical, biotech, or CDMO environments.
- 2–5 years of direct project management experience.
- Strong knowledge of GMP regulations and operating within a regulated environment.
- Proficiency with project management tools (e.g., PPM systems, Smartsheet).
Nice To Haves
- 2+ years of CDMO experience.
- Experience managing late-stage programs (PPQ, BLA preparation, commercialization readiness) and/or commercial programs.
- Experience leading technology transfer and new product introductions.
- Familiarity with TrackWise.
Responsibilities
- Lead CMC development, technology transfer, and GMP manufacturing programs from project award through close-out.
- Develop and maintain detailed project plans to ensure right-first-time delivery within scope, timeline, and budget.
- Serve as the primary point of contact for clients, ensuring clear communication and alignment of expectations.
- Partner with Business Development to support and strengthen client relationships.
- Proactively identify risks, develop mitigation strategies, and resolve technical or operational challenges in collaboration with functional leads.
- Establish contingency plans, monitor risk triggers, and escalate issues as needed.
- Drive cross-functional alignment across PD, Analytical, QC, QA, MSAT, Supply Chain, and Manufacturing.
- Support late-stage program activities including PPQ readiness, regulatory submissions (e.g., BLA), and commercialization efforts.
- Apply knowledge of biologics development, including cell line development, upstream and downstream processing, and analytical requirements, to support technical decision-making and tech transfer activities.
- Manage financial and contractual aspects of programs, including authoring Project Change Orders.
- Provide accurate milestone updates to Finance for forecasting, work assessment, and timely client invoicing.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
