Director, Biologics Drug Product Development
AbbVie
Summary
Biologics Drug Product Development (Bio DPD), a part of Development Sciences within AbbVie's R&D, is a global organization responsible for drug product formulation and process development and definition of the product presentation for biologics (proteins, conjugates, peptides, neurotoxins etc.) and genetic medicine (AAV, LNPs, Cell Therapy). AbbVie is seeking a highly motivated candidate for the position of Director, located in North Chicago, IL. This position will be an integral part of the product development and CMC teams and will have strong collaborations with several stakeholders, including discovery research, analytical research and development, bioprocess development, combination products development, product development science and technology, pilot plants and third-party manufacturers.
Job description
Key Responsibilities
- Provide strategic and technical oversight for drug product development of ultra-high concentration drug product formulation and process development and technology transfer, including fixed dose combinations for a wide range of biologics modalities.
- Oversee drug product development of a portfolio of 5-7 pipeline programs spanning early- and late-stage development, including management of external partnerships as appropriate.
- Effective and timely communication of development plans, risks, and mitigation plans to stakeholders and line management.
- Initiate and/or sponsor scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes.
- Accountable for the timely authoring of high-quality technical reports as well as drug product sections in global regulatory filings.
- Serve as drug product development subject matter expert in due diligence of external opportunities.
- Supervise and mentor a team of 8-10 scientists that may include technical group leaders.
Required Qualifications
- BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with 18+ (Bachelors), 16+ (Masters), or 10+ (PhD) years of relevant industry experience.
- Proven ability to solve critical scientific problems.
- Extensive experience in biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic molecules and/or genetic medicine (AAV, LNPs, cell therapy) drug product development.
- Experience in sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling, lyophilization) development.
- Experience leading drug product development as the functional lead within cross-functional teams.
- 5+ years of progressive people management roles.
Preferred Qualifications
- Experience with development and commercialization of ultra-high concentration liquid formulations for fixed dose combinations and drug product-device integration.
- Hands-on experience with authoring regulatory filings for biologics and sterile parenteral products.
- Understanding of relevant cGMP and regulatory guidance for biologics and sterile parenteral products.
- Experience in managing third-party manufacturers of sterile parenteral products.
- Experience with quality risk management and control strategies for biologics and sterile parenteral products.
Key Competencies
- Deep scientific knowledge and significant hands-on experience with ultra-high co-formulation development and characterization.
- Effectively communicates to influence without authority, drives technical excellence, and inspires continuous improvement.
- Builds strong relationships with peers and cross-functional partners to enable higher performance.
- Connects ideas from disparate fields, integrates data and information quickly, and takes risks to achieve the highest performance.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.
Requirements
- BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines
- 18+ years relevant industry experience with Bachelors, 16+ with Masters, or 10+ with PhD
- Proven ability to solve critical scientific problems
- Extensive experience in biologics, parenteral synthetic molecules and/or genetic medicine drug product development
- Experience in sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling, lyophilization) development
- Experience leading drug product development as functional lead within cross-functional teams
- 5+ years of progressive people management roles
Benefits
- Paid Time Off
- Medical, Dental & Vision Insurance
- 401(k)
- Long-Term Incentive Programs
Company overview
AbbVie is a global biopharmaceutical company that discovers, develops, and markets advanced therapies for some of the world's most complex and serious diseases. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie has established itself as a leader in immunology, oncology, neuroscience, eye care, and virology. The company's flagship product, Humira (adalimumab), was one of the world's top-selling drugs for treating autoimmune conditions like rheumatoid arthritis and Crohn's disease. AbbVie maintains a robust pipeline of innovative medicines and has expanded its portfolio through strategic acquisitions, including Allergan in 2020. With research facilities across the United States and globally, AbbVie focuses on advancing science to improve patient outcomes while maintaining strong commercial operations worldwide. The company operates with a patient-centric approach and invests significantly in research and development to address unmet medical needs across multiple therapeutic areas.