Associate Director, Drug Product Manufacturing Direct Hire MA
Job ID: 16218 Direct Hire MA
Do you have experience with commercialization and/or late-stage development of a cellular product, gene therapy or biologic? Have you received training in LEAN and/or Six Sigma or continuous process improvement? Is leading projects and people something you are passionate about? If so, there is a role waiting for you at one of the top cell & gene therapy companies in the Cambridge/Boston area!
This role is with a mid-size company and they have a culture that can't be beat. Don't miss your chance to make a significant impact for patients afflicted with rare diseases and cancer.
The main function of this role is to lead the transition to commercial readiness and drive efficiencies across GMP operations for their gene therapy portfolio.
Responsibilities include but are not limited to;
• Lead drug product commercial-readiness activities required to achieve necessary scalability, flexibility and efficiency necessary to support commercial launch
• Optimizing operational models and internal and external processes
• Designing, selecting and implementing systems across network of external partners and CDMOs.
• Identifying and implementing efficiencies and reducing cost of goods for manufacturing processes
• Process improvement via data capture, trending and analytics
• Build, manage and lead effective teams through the appropriate application of lean six sigma principles, tiered accountability and key performance indicators
• Travel to external manufacturing partners / contract manufacturing organizations (CMOs) to foster strong relationships (travel expected to be approximately 15-20%)
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have a BS degree or higher and 7-10+ years of experience in cGMP manufacturing of clinical and commercial programs. Must have experience in biologics and/or cell/gene therapies and prior cGMP manufacturing experience for commercial products, ideally inclusive of launch activities. Experience and/or certification in continuous improvement such as LEAN, Six Sigma, Operational Excellence, Kaizen and/or project management experience is a significant plus.
Must be authorized to work in the US indefinitely to be considered. Relocation assistance available for qualified candidates. All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.