Director, Drug Product Development, CMC Biologics

Director, Drug Product Development, Biologics CMC Development

Position Description:

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). 

Responsibilities:

• 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.

Qualifications:

• 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.

Applicable to California Applicants Only 

·         The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California.

This range may be modified in the future. 

·         The salary range is (minimum: _$146,000 to maximum:_$285,000) 

·         This job is eligible to participate in our short-term incentive program 

·         This job is eligible to participate in our long-term incentive programs 

·         We offer comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. 

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.