Senior Scientist II / Principal Scientist I, Biologics Drug Product Development
AbbVie
- Location
- North Chicago, IL, United States
- Employment
- Full Time
- Work model
- On-Site
- Level
- Principal
- H-1B history
- 94 approvals (FY2023)
- Posted
- 1h ago
About this role
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
Job Description
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 Senior Scientist II, located in North Chicago, IL. We are seeking an accomplished scientist with a proven track record in biologics drug product process development, modeling, scale-up and tech transfer. 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.
Key Responsibilities
Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies. Support scale-up and technology transfer activities to internal and external manufacturing sites. Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes. Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and line management. Represent Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team.
Qualifications
This position can be hired at the Sr. Scientist II or Principal Scientist I level depending on years of experience and education Qualifications for the Sr. Scientist II: Senior Scientist II: 12+ (Bachelors), 10+ (Masters), or 4+ (PhD) years of relevant industry experience. Proven ability to solve critical scientific problems. Experience with biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic molecules and/or genetic medicine (AAV, LNPs, cell therapy) drug product process development. Experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling, lyophilization), characterization, scale-down models, simulation, scale-up, technology transfer, and batch record authoring. Hand-on experience with authoring regulatory filings for biologics and sterile parenteral products Experience leading drug product development as the functional lead within cross-functional teams Preferred Qualifications: Biologics drug product formulation development 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 Qualifications for the Principal Scientist I: BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with Principal Scientist I: 14+ (Bachelors), 12+ (Masters), or 6+ (PhD) years of relevant industry experience. Proven ability to solve critical scientific problems. Experience with biologics (proteins, conjugates, peptides and/or