Associate Director, CMC-Pharma Product Group
AbbVie
8 hours ago
Remote friendly (Waltham, MA)
United States
Operations
Responsibilities:
- Lead cross-functional S&T product teams; represent CMC and/or S&T with S&T leadership, other Operations functions, other AbbVie functions, and external partners.
- Participate in or coordinate governance efforts (e.g., Product Performance Teams, gate reviews).
- Develop comprehensive project plans, budgets, timelines, and strategy for biologics projects from Phase I through commercial.
- Present technical information on biologics manufacturing, process development, and process characterization to management and regulatory agencies.
- Prepare and review regulatory briefings and submissions to support clinical trials (through registration) and post-approval lifecycle management.
- Manage multiple projects at various stages of development.
- Represent assigned projects on the multidisciplinary Asset Development Team.
Qualifications:
- Ph.D. in biochemistry, biochemical engineering, cell biology, or related field with 8+ years industrial experience (or equivalent), or Master’s degree with 16 years relevant experience.
- Very strong writing, presentation, and communications skills.
- Significant technical understanding of biologics manufacturing, including quality and analytical issues.
- Ability to work in a highly matrixed team and influence scientists/SMEs across disciplines.
- Ability to meet tight timelines.
- Experience supporting/developing biologics manufacturing processes, analytical development, or biologics process validation.
- CMC development experience through IND and/or NDA/MAA.
- Experience leading multiple CMC project teams through IND and NDA/MAA (preferred).
- Technical understanding/experience with small molecule product manufacturing, development, quality, and analytics.
- Knowledge of FDA and global regulatory requirements for CMC; ability to influence internal and external experts independently.
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) to eligible employees.
- Eligibility for long-term incentive programs.
Application instructions:
- None provided in the job description text.
- Lead cross-functional S&T product teams; represent CMC and/or S&T with S&T leadership, other Operations functions, other AbbVie functions, and external partners.
- Participate in or coordinate governance efforts (e.g., Product Performance Teams, gate reviews).
- Develop comprehensive project plans, budgets, timelines, and strategy for biologics projects from Phase I through commercial.
- Present technical information on biologics manufacturing, process development, and process characterization to management and regulatory agencies.
- Prepare and review regulatory briefings and submissions to support clinical trials (through registration) and post-approval lifecycle management.
- Manage multiple projects at various stages of development.
- Represent assigned projects on the multidisciplinary Asset Development Team.
Qualifications:
- Ph.D. in biochemistry, biochemical engineering, cell biology, or related field with 8+ years industrial experience (or equivalent), or Master’s degree with 16 years relevant experience.
- Very strong writing, presentation, and communications skills.
- Significant technical understanding of biologics manufacturing, including quality and analytical issues.
- Ability to work in a highly matrixed team and influence scientists/SMEs across disciplines.
- Ability to meet tight timelines.
- Experience supporting/developing biologics manufacturing processes, analytical development, or biologics process validation.
- CMC development experience through IND and/or NDA/MAA.
- Experience leading multiple CMC project teams through IND and NDA/MAA (preferred).
- Technical understanding/experience with small molecule product manufacturing, development, quality, and analytics.
- Knowledge of FDA and global regulatory requirements for CMC; ability to influence internal and external experts independently.
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) to eligible employees.
- Eligibility for long-term incentive programs.
Application instructions:
- None provided in the job description text.