Associate Director, Biologics Drug Product Development
About The Position
Biologics Drug Product Development (Bio DPD), a part of Development Sciences within AbbVie’s R&D, is a global organization that is 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 Associate Director, located in North Chicago, IL. We are seeking an accomplished scientist with a proven track record in biologics drug product development. 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.
Requirements
- Bachelors, Masters, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with 16+ (Bachelors), 14+ (Masters), or 8+ (PhD) years of relevant industry experience
- Proven ability to solve critical scientific problems
- Strong experience working with external partners, contract research organizations and third-party manufacturers
- Strong experience with biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic molecules and/or genetic medicine (AAV, LNPs, cell therapy) drug product formulation and process development, and tech transfer
- Extensive experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling) development and transfer
- Experience as CMC cross-functional matrix team leader with strong ability to influence without authority
- 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 with quality risk management and control strategies for biologics and sterile parenteral products
Nice To Haves
- Deep scientific knowledge and significant hands-on experience with biologics and parenteral drug product development
- 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
Responsibilities
- Serve as single point of contact for programs developed in collaboration with external partners.
- Develop and execute robust drug product development strategies for external programs.
- Serve as a drug product team leader for one or more projects and represents Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team.
- Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and line management.
- Support due diligence for business development opportunities.
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- long-term incentive programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
