Director, ADC Process Development
AbbVie
6 months ago
Remote friendly (Waltham, MA)
United States
Operations
Responsibilities:
- Provide mature, credible CMC leadership; mentor and support people managers and future leaders; coach scientists/engineers to build cross-functional CMC experience.
- Provide a positive leadership model for scientists; maintain and direct a highly diversified cross-functional staff to complete CMC development on time while meeting scientific, regulatory, quality, and commercial standards.
- Drive development of platform technologies and innovation to improve operational efficiency and reduce cost of goods.
- Provide rapid and accurate evaluation of new business opportunities.
- Develop and communicate cost estimates, business plans, timelines, and contingency plans; distill technical and cross-functional updates for clear leadership communication.
- Identify and recruit resources to meet project and departmental objectives within agreed scope; maintain open communication and emphasize scientific/compliance excellence.
- Make go/no-go decisions for assigned project responsibilities.
- Represent the company to regulatory agencies (US/ROW as appropriate) via verbal/written information and/or meeting participation; operate cross-functionally with CMC stakeholders (R&D, manufacturing, regulatory, quality, analytical development).
Qualifications:
- Master’s degree or equivalent related experience in a scientific field (required).
- PhD or equivalent experience in a related scientific discipline (highly desired).
- 10+ years of pharmaceutical development/manufacturing experience, including 6+ years managerial experience.
- Strong background in process development, technical issue resolution, and technical/manufacturing/regulatory/compliance areas.
Preferred Qualifications:
- PhD in Chemical Engineering, Biochemistry, or Chemistry (10+ years); or Master’s degree (14+ years).
- Expertise in process development, tech transfer, continuous process improvement, and new technology implementation.
- Demonstrated people management success developing cross-functional leaders and communicators.
- Strong understanding of QbD; experience with late-stage process development, process characterization, and control strategy development.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) (to eligible employees).
- Eligible for long-term incentive programs.
- Provide mature, credible CMC leadership; mentor and support people managers and future leaders; coach scientists/engineers to build cross-functional CMC experience.
- Provide a positive leadership model for scientists; maintain and direct a highly diversified cross-functional staff to complete CMC development on time while meeting scientific, regulatory, quality, and commercial standards.
- Drive development of platform technologies and innovation to improve operational efficiency and reduce cost of goods.
- Provide rapid and accurate evaluation of new business opportunities.
- Develop and communicate cost estimates, business plans, timelines, and contingency plans; distill technical and cross-functional updates for clear leadership communication.
- Identify and recruit resources to meet project and departmental objectives within agreed scope; maintain open communication and emphasize scientific/compliance excellence.
- Make go/no-go decisions for assigned project responsibilities.
- Represent the company to regulatory agencies (US/ROW as appropriate) via verbal/written information and/or meeting participation; operate cross-functionally with CMC stakeholders (R&D, manufacturing, regulatory, quality, analytical development).
Qualifications:
- Master’s degree or equivalent related experience in a scientific field (required).
- PhD or equivalent experience in a related scientific discipline (highly desired).
- 10+ years of pharmaceutical development/manufacturing experience, including 6+ years managerial experience.
- Strong background in process development, technical issue resolution, and technical/manufacturing/regulatory/compliance areas.
Preferred Qualifications:
- PhD in Chemical Engineering, Biochemistry, or Chemistry (10+ years); or Master’s degree (14+ years).
- Expertise in process development, tech transfer, continuous process improvement, and new technology implementation.
- Demonstrated people management success developing cross-functional leaders and communicators.
- Strong understanding of QbD; experience with late-stage process development, process characterization, and control strategy development.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) (to eligible employees).
- Eligible for long-term incentive programs.