Director, Drug Product Development, Biologics CMC Development
For the Biologics Drug Product R&D Director position, we are seeking a highly motivated, experienced leader to lead a diverse team of pharmaceutical development scientists supporting the development of therapeutic biologics from early development through commercialization, with a specific focus on neurotoxins for therapeutics and aesthetics use. The candidate should have extensive expertise in biologics formulation and drug product process development, scale up, and technology transfer. The candidate should have experience with early and late-stage development for therapeutic biologics; experience with life-cycle management programs including combination product development is a plus. He/she must be able to provide leadership, mentor and develop scientists across a range of different experience levels and must foster productive collaborations within the global Biologics Drug Product Development organization and with R&D cross-functional partners and across functions such as Discovery Research, Operations, Quality Assurance and Science & Technology (S&T).
- Lead a team of formulation scientists working with cross-functional R&D partners to develop therapeutic biologic candidates from early development through BLA approval, including life-cycle management programs.
- Actively contribute to cross-functional CMC strategic discussions, ensuring drug product development plans are aligned with the team goals.
- Provide strong functional technical leadership and ensure timely completion of all functional deliverables including reports and applicable quality and regulatory documents.
- Implement and manage functional processes and workflows for operational excellence, raising the performance bar for the team.
- Evaluate and recommend new technologies to enhance fundamental protein degradation understanding and formulation stabilization strategies. Foster an environment of innovation and scientific excellence.
- Form strong alliances with partner functions to ensure robust and effective technology transfer transfers and control strategy implementation.
- Encourage ideas and drive for continuous improvement and champion initiatives within the Drug Product R&D organization and across R&D partner functions.
- Recruit and develop top talent to create and maintain a productive team of highly skilled scientists and project leaders. Establish and maintain an environment that ensures the retention of key talent through continued development opportunities and recognition of key accomplishments.
- Understand and comply with AbbVie safety, quality and regulatory policies and government regulations.
- Ph.D. with 10+ years of experience or MS Degree with at least 16+ years of related industry experience preferred or BS Degree with at least 18 years of related industry experience required. Advanced degree in Pharmaceutical Sciences, Chemistry and/or Chemical Engineering preferred.
- 6+ years of experience in technical leadership role that includes experience managing and mentoring people.
- Demonstrated technical experience in leading formulation and drug product process development of biologics, including process scale-up from pilot plants to commercial facilities required.
- Experience with late-stage CMC development is highly desirable. Experience with life-cycle management programs including combination product development is a plus.
- Participation in cross-functional CMC development teams and experience in leading global functional initiatives is highly desirable.
- Demonstrated capability to solve critical scientific and business problems.
- Excellent communication skills are required.
- Understanding of cGMP, cGLP and regulatory requirements for clinical development and marketing authorizations in the U.S. and OUS
This position requires the individual to work with and in areas requiring select agents and Toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.