Senior Scientist II / Principal Scientist I, Biologics Drug Product Development
AbbVie
1 month ago
Remote friendly (North Chicago, IL)
United States
Operations
Senior Scientist II / Principal Scientist I (North Chicago, IL)
Key Responsibilities
- Represent 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 scale-up and technology transfer activities to internal and external manufacturing sites.
- Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
- Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes.
Qualifications
- BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines.
- Senior Scientist II: 12+ (Bachelors), 10+ (Masters), or 4+ (PhD) years of relevant industry experience.
- 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 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.
- Experience leading drug product development as the functional lead within cross-functional teams.
Preferred Qualifications
- Hand-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.
Benefits (if applicable to this role section)
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible to participate in short-term incentive programs.
Key Responsibilities
- Represent 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 scale-up and technology transfer activities to internal and external manufacturing sites.
- Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
- Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes.
Qualifications
- BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines.
- Senior Scientist II: 12+ (Bachelors), 10+ (Masters), or 4+ (PhD) years of relevant industry experience.
- 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 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.
- Experience leading drug product development as the functional lead within cross-functional teams.
Preferred Qualifications
- Hand-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.
Benefits (if applicable to this role section)
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible to participate in short-term incentive programs.