Senior Manager of CMC - Quality Assurance

Job Responsibilities

• Member of CMC Development Teams providing Quality (QA) input from pre-clinical to end of product life cycle, including NDA filing, other market filings, and post approval changes.
• Partners with technical SMEs to develop and approve the CMC strategy (DS, DP, and analytical strategy) for new drug candidates.
• Responsible for change control management, for compound/product-specific changes, through the product lifecycle to include impact assessments, tracking, and implementation.
• Also, as appropriate and compound/product specific, responsible Quality member for oversight and QA approver of all key Quality System deliverables associated with the drug development candidate including, Deviations, Investigations, CAPAs, and Complaints.
• Review and approve compound/product specific analytical method life cycle documents (e.g., API and bulk drug product specifications, analytical test methods (including micro), and protocols/reports); including stability.
• Work with CMC Teams to conduct compound/product specific risk assessments, as required, for all aspects of the drug development process.
• Responsible for communicating Quality risks within the Quality organization.
• Collaborate with Regulatory to track/own Quality input for ongoing regulatory filings and updates to Health Authorities (e.g. IND/IMPD/BLA/NDA) including specifications, shelf-life extensions, country specific trial approvals, etc.
• Performs other tasks as assigned (e.g., final Quality reviewer/approver of Quality events and/or GMP documentation, actively contributes to ongoing investigations as required).

Education And Experience

• Minimum of B.S. degree, preferably in Chemistry, Biochemistry, or a similar Scientific field.
• Five plus years of hands-on biologics/sterile experience within a development/operations facility - manufacturing and/or analytical.

Skills And Qualifications

• Thorough knowledge of the Pharmaceutical Development processes as evidenced by bringing multiple INDs through to successful BLA/NDA approval.
• Knowledge of bulk biologic drug substance (monoclonal antibody, bispecific, etc.), parenteral (cold chain liquid/lyophilized form) drug product, cell/gene therapy product process development/manufacturing, and/or development/manufacturing of radiopharmaceuticals is required.
• Recognized as a CMC expert, radiopharmaceuticals and/or biologics, with an ability to introduce best practices into the quality management systems.
• Thorough understanding of cGMPs and regulatory requirements (e.g., FDA, EU, ICH).
• Well-versed in relevant CMC area, with an ability to introduce Quality-relevant (phase appropriate) best practices into the CMC development processes.
• Excellent investigational and QA problem-solving skills.
• Analytical mindset, with an ability to assess new situations to define and implement the appropriate QA action plan.
• Ability to work independently, yet effectively in a team environment.
• Superior attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.
• Teamwork oriented with the ability to work effectively across functional groups and teams to ensure requirements are met (e.g., early phase, late phase, regulatory).
• Applies AI to improve team execution and decision-making.
• Continuous improvement mindset is also required.