Manufacturing

Associate Director, Drug Product Manufacturing  Direct Hire MA

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Job ID: 16218 Direct Hire MA

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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.

Sr. Cell Bank Change Control Specialist Direct Hire MA

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Job ID: 16185 Direct Hire MA

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Our client is a large, international biopharmaceutical company with two dozen global sites and a large portfolio of approved therapeutics and a robust pipeline.  

The main function of this role is to implement Change Controls related to Cell Bank projects, in adherence to the New Product Introduction and own Change Control process for Cell Bank activities from initiation, through implementation and closeout. 

Responsibilities include but are not limited to;
•  Identify key resources to support selected projects and use escalation guidelines and risk mitigation to deliver projects according to plan.
•  Actively own and manage Change Controls (initiation through closure) as they relate to Cell Bank projects including but not limited to operations, processes, raw materials, equipment, technical transfers (new processes and technology) testing, and introduction to manufacturing site facilities.
• Support change controls for release and storage stability of cell banks
• Effective use of project management & OE tools (options analysis, risk facilitation, decision matrix, ROI, communication, escalation plans, etc).
• Demonstrate knowledge and expertise in bridging technical and business disciplines as they relate to cell banking
• Collaborate with global sites and network for Change Control projects that may include but not limited to cell bank release, cell bank at scale qualifications, transportation of cell banks, new storage sites for cell banks
• Work with Regulatory to support submission of filings and participate in regulatory and non-regulatory audits.  
• Lead/Support Kaizens and problem solving sessions for high level and complex events, including contamination
• Use investigation/lean tools to develop robust root cause analysis and drive robust actions to ensure elimination of root cause
• Identify and implement process improvement to drive success in the areas of compliance, throughput, workplace safety, cost effectiveness, and product lead time.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS degree or higher with 4+ years of cGMP biopharmaceutical industry experience.  NO prior Cell Banking experience required but welcome.  Must have Change Control experience.  Because of the cross-functional nature of the role, qualified candidates must have excellent verbal and written communications skills to be considered. Prior experience managing projects and schedule development is a plus. 

Must be authorized to work in the US indefinitely to be considered and commutable to the Waltham/Lexington, MA area or able to relocate with limited assistance.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.