Senior Scientist I, Drug Product Development
AbbVie · North Chicago, IL · 1 mo ago
AnalystFull-time
About the role
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, focusing on immunology, oncology, neuroscience, and the Allergan Aesthetics portfolio. More information is available at www.abbvie.com; follow @abbvie on LinkedIn, Facebook, Instagram, X, and YouTube. The Biologics Drug Product Development (Bio DPD) group within Development Sciences is responsible for drug product formulation and process development, and definition of product presentation for biologics and genetic medicines (proteins, conjugates, peptides, etc.). AbbVie is seeking a Senior Scientist I, Biologics Drug Product Development in North Chicago, IL.
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.
- Keep abreast of the latest advances in biologics formulation and process technologies.
- Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and improve business processes.
- May represent the Bio DPD function in the cross‑functional Product Presentation and Device Strategy Team (PPDST) and the CMC team.
- Effectively and timely communicate study plans, risks, and mitigation plans to stakeholders and line management.
Qualifications
- Bachelor’s Degree or equivalent education and typically 10 years of experience; Master’s Degree or equivalent education and typically 8 years of experience; PhD with 0+ years of industry experience.
- Proven ability to solve critical scientific problems.
- Hands‑on experience with biologics formulation development.
- Hands‑on experience with analytical and biophysical characterization of proteins and solid‑state characterization methods.
- Solid understanding of biologics degradation mechanisms and stabilization strategies.
- Hands‑on experience with Design of Experiments (DoE), multivariate statistical analyses, and data visualization tools.
- Highly preferred: understanding of relevant cGMP and regulatory guidance.
- Highly preferred: experience with sterile manufacturing unit operations (freeze‑thaw, mixing, filtration, filling, lyophilization) development, characterization, scale‑up, and technology transfer.
- Highly preferred: experience managing third‑party manufacturers.
- Highly preferred: experience with quality risk management and drug product control strategies.
Benefits
- Paid time off (vacation, holidays, sick)
- Medical, dental, and vision insurance
- 401(k) plan for eligible employees
- Eligibility to participate in short‑term incentive programs