Associate Director / Director - Biologics Drug Product Development
About The Position
AbbVie’s Biologics Drug Product Development (Bio DPD) organization is part of Development Sciences within R&D. It is responsible for drug product formulation and process development, and defining product presentations for biologics—including proteins, conjugates, peptides, and neurotoxins—and genetic medicines such as AAV, LNPs, and cell therapy. AbbVie is seeking an accomplished scientist to join the organization in North Chicago, Illinois. The role is an integral part of product development and CMC teams, collaborating with stakeholders across discovery research, analytical R&D, bioprocess development, combination products development, product development science and technology, pilot plants, and third-party manufacturers. The position may be filled at the Associate Director or Director level depending on the candidate’s qualifications and experience. The role provides strategic and technical leadership for biologics drug product formulation and process development, including ultra-high-concentration formulations and fixed-dose combinations. It oversees a portfolio of 5–7 pipeline programs across early- and late-stage development, communicates development plans and risks, advances scientific capabilities and processes, and ensures timely technical reports and regulatory filing content. The position also serves as a subject matter expert for external opportunity due diligence and supervises and mentors a team of 8–10 scientists, potentially including technical group leaders.
Requirements
- For Director: BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline, with at least 18 years of relevant industry experience for a bachelor's degree, 16 years for a master's degree, or 10 years for a PhD.
- For Associate Director: BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline, with at least 16 years of relevant industry experience for a bachelor's degree, 14 years for a master's degree, or 8 years for a PhD.
- Proven ability to solve critical scientific problems.
- Extensive experience in drug product development for biologics (proteins, conjugates, peptides, and/or neurotoxins), parenteral synthetic molecules, and/or genetic medicines (AAV, LNPs, or 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 developing and commercializing 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.
- A 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 implementation.
Responsibilities
- Provide strategic and technical oversight for drug product formulation and process development and technology transfer, including ultra-high-concentration formulations and fixed-dose combinations across a range of biologics 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 in a timely manner 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 the 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 leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
