Senior Manager, CMC Process Development

Senior Manager, CMC Process Development

Requirements

• Bachelor’s Degree in science (e.g., chemistry, biotechnology, pharmaceutical sciences, or related discipline)
• Eight (8) years of relevant experience in pharmaceutical/biotechnology industry experience in managing CDMOs for the manufacture of non GMP and cGMP DS and DP
• Experience with projects clinical through Phase 3, BLA including multiple molecule types (cell and gene therapy experience a plus)
• Strong leadership skills with ability to be hands-on and lead/manage the CMC programs
• Thorough knowledge of cGMP manufacturing and filings; thorough and relevant knowledge of FDA and EMA regulations
• Strong skills in identifying and resolving critical issues
• Strong track record in effectively working with senior management.

Responsibilities

• Work closely with colleagues to support late-stage CMC development for cretostimogene in alignment with corporate objectives.
• Collaborate with the CDMO and leader to closely plan CMC programs (upstream and downstream manufacturing, drug product and analytical activities), from clinical development through clinical supplies for Phase 3 and BLA, including projection of DP needs, budgets, and timelines.
• Develop and implement a strategy and DOE (design of experimentation) for optimizing and controlling quality of bulk DP using CDMOs.
• Execute plans in accordance with cGMP, ICH, and FDA regulations.
• Partner with and maintain regular contact with key stakeholders including, Quality Assurance, Regulatory Affairs, Medical/Clinical Operations, Commercial Operations, Legal, Finance, and Project Management.
• Review relevant sections for regulatory submissions.
• Collaborating with colleagues to select and manage Contract Manufacturing Organizations (CMOs) for process optimization, non-GMP and cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of ongoing clinical programs.
• Monitor the tactical implementation of the manufacturing programs, including delivery of scalable and cost-effective manufacturing routes that meet or exceed the target clinical profile.
• Review cGMP batch records, CMC regulatory and quality documents.
• Collaborate with colleagues and manager to identify late-stage activities supporting BLA completion for cretostimogene.
• Maintain strong relationships with manufacturing partners, participate in business review meetings, review KPIs, provide forecasts, and plan resource utilization.
• Collaborate with Project Management (PMO) to develop timelines and ensure resource availability for project milestones.
• Review manufacturing plans, technical data development reports and BLA submissions.

Preferred Qualifications

• Cell and gene therapy experience a plus