Director, Biologics Drug Product Development
About The Position
AbbVie’s Biologics Drug Product Development (Bio DPD), part of Development Sciences within R&D, is a global organization responsible for drug product formulation and process development and defining product presentations for biologics and genetic medicines. AbbVie seeks an accomplished scientist to lead biologics drug product development in North Chicago, Illinois. The position is an integral part of product development and CMC teams and collaborates with discovery research, analytical research and development, bioprocess development, combination products development, product development science and technology, pilot plants, and third-party manufacturers. The role may be filled at the associate director or director level depending on the candidate’s qualifications and experience. The position provides strategic and technical oversight for ultra-high concentration drug product formulation and process development, technology transfer, and fixed-dose combinations across biologic modalities. It oversees a portfolio of 5–7 pipeline programs spanning early- and late-stage development, and supervises and mentors a team of 8–10 scientists, potentially including technical group leaders.
Requirements
- BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline.
- Relevant industry experience for the Director level: 18 or more years with a bachelor’s degree, 16 or more years with a master’s degree, or 10 or more years with a PhD.
- Proven ability to solve critical scientific problems.
- Extensive drug product development experience in biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic molecules, and/or genetic medicines (AAV, LNPs, cell therapy).
- Experience developing sterile manufacturing unit operations, including freeze-thaw, compounding, mixing, filtration and filling, and lyophilization.
- Experience leading drug product development as the functional lead within cross-functional teams.
- At least 5 years in progressive people-management roles.
Nice To Haves
- Experience with development and commercialization of ultra-high concentration liquid formulations for fixed-dose combinations and drug product-device integration.
- Hands-on experience authoring regulatory filings for biologics and sterile parenteral products.
- Understanding of relevant cGMP and regulatory guidance for biologics and sterile parenteral products.
- Experience managing third-party manufacturers of sterile parenteral products.
- Experience with quality risk management and control strategies for biologics and sterile parenteral products.
- Deep scientific knowledge and significant hands-on experience with ultra-high co-formulation development and characterization.
- Ability to communicate effectively to influence without authority, drive technical excellence, and inspire continuous improvement.
- Ability to build strong relationships with peers and cross-functional partners to enable higher performance.
- Ability to connect ideas from disparate fields, integrate data and information quickly, and take risks to achieve high performance.
- Commitment to raising the bar and challenging the status quo.
- Ability to create a learning environment that is open to suggestions and experimentation for improvement.
- Ability to embrace others’ ideas, nurture innovation, and manage innovation through to implementation.
Responsibilities
- Provide strategic and technical oversight for ultra-high concentration drug product formulation and process development and technology transfer, including fixed-dose combinations across a wide range of biologic modalities.
- Oversee drug product development for a portfolio of 5–7 pipeline programs spanning early- and late-stage development, including management of external partnerships as appropriate.
- Communicate development plans, risks, and mitigation plans effectively and on time to stakeholders and line management.
- Initiate and/or sponsor scientific initiatives to drive innovation, enhance capabilities and platforms, and improve business processes.
- Ensure timely authoring of high-quality technical reports and drug product sections of global regulatory filings.
- Serve as a drug product development subject matter expert in due diligence of external opportunities.
- Supervise and mentor a team of 8–10 scientists, potentially including technical group leaders.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k).
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Director
