Senior Scientist II
AbbVie
5 hours ago
On-site
North Chicago, IL
Clinical Research and Development
Responsibilities:
- Independently design and conduct critical experiments to advance parenteral drug product (DP) development goals; may innovate with new protocols/techniques for DP characterization to enable process scale-up.
- Interpret results from multistage experiments, note significant deviations, and suggest/design/pursue relevant follow-up experiments.
- Lead tech transfer for parenteral DP from development scale-up to clinical/commercial scale.
- Support drug product manufacture at GMP facilities from clinical to PPQ and commercial batches.
- Apply scientific literature and theoretical frameworks to solve problems within the scientific discipline in a timely manner.
- Author comprehensive, scientifically sound reports (e.g., development reports and/or risk assessments) supporting regulatory submissions; author portions of regulatory submissions to designated health authorities.
- Develop and maintain project plans, timelines, and tech transfer strategy across development stages (from Phase I through post-launch).
- Lead PDS&T product teams; represent CMC/PDS&T in cross-functional and external partner interfaces; coordinate governance activities (e.g., Product Performance Teams, gate reviews).
- Prepare/review registration and post-approval life-cycle submissions; serve as peer reviewer and understand how submissions constrain operational changes.
- Establish and foster partnerships with customers and counterpart functions; identify and promote best practices among PDS&T CMC leads.
- Adhere to corporate standards for code of conduct, safety, material handling, controlled drug/radioactive compounds, GxP compliance, and animal care (as applicable).
Qualifications:
- Bachelors, Masters, or PhD in chemical engineering, pharmaceutical sciences, chemistry, pharmaceutics, or related disciplines with typically 12+ (BS), 10+ (MS/equivalent), or 4+ (PhD) years of experience.
- Strong laboratory skills in manufacturing process development for monoclonal antibodies, antibody drug conjugates, or other parenteral formulations.
- Knowledge/experience with aseptic parenteral manufacturing (vials, prefilled syringes, prefilled cartridges).
- Scientific problem solving, experimental design, and troubleshooting skills.
- Solid understanding of aseptic unit operations for liquid and lyophilized products: bulk freeze/thaw, compounding/mixing, filtration, filling, and lyophilization.
- Experience with laboratory documentation systems (e.g., ELN) and technical report writing.
- Experience managing/leading junior scientists for development/tech transfer.
- Required: knowledge of FDA and global regulatory requirements for CMC issues.
- Ability to influence internal/external experts independently on CMC regulatory issues.
- Demonstrated excellence in writing, presentation, and communication.
- Independently design and conduct critical experiments to advance parenteral drug product (DP) development goals; may innovate with new protocols/techniques for DP characterization to enable process scale-up.
- Interpret results from multistage experiments, note significant deviations, and suggest/design/pursue relevant follow-up experiments.
- Lead tech transfer for parenteral DP from development scale-up to clinical/commercial scale.
- Support drug product manufacture at GMP facilities from clinical to PPQ and commercial batches.
- Apply scientific literature and theoretical frameworks to solve problems within the scientific discipline in a timely manner.
- Author comprehensive, scientifically sound reports (e.g., development reports and/or risk assessments) supporting regulatory submissions; author portions of regulatory submissions to designated health authorities.
- Develop and maintain project plans, timelines, and tech transfer strategy across development stages (from Phase I through post-launch).
- Lead PDS&T product teams; represent CMC/PDS&T in cross-functional and external partner interfaces; coordinate governance activities (e.g., Product Performance Teams, gate reviews).
- Prepare/review registration and post-approval life-cycle submissions; serve as peer reviewer and understand how submissions constrain operational changes.
- Establish and foster partnerships with customers and counterpart functions; identify and promote best practices among PDS&T CMC leads.
- Adhere to corporate standards for code of conduct, safety, material handling, controlled drug/radioactive compounds, GxP compliance, and animal care (as applicable).
Qualifications:
- Bachelors, Masters, or PhD in chemical engineering, pharmaceutical sciences, chemistry, pharmaceutics, or related disciplines with typically 12+ (BS), 10+ (MS/equivalent), or 4+ (PhD) years of experience.
- Strong laboratory skills in manufacturing process development for monoclonal antibodies, antibody drug conjugates, or other parenteral formulations.
- Knowledge/experience with aseptic parenteral manufacturing (vials, prefilled syringes, prefilled cartridges).
- Scientific problem solving, experimental design, and troubleshooting skills.
- Solid understanding of aseptic unit operations for liquid and lyophilized products: bulk freeze/thaw, compounding/mixing, filtration, filling, and lyophilization.
- Experience with laboratory documentation systems (e.g., ELN) and technical report writing.
- Experience managing/leading junior scientists for development/tech transfer.
- Required: knowledge of FDA and global regulatory requirements for CMC issues.
- Ability to influence internal/external experts independently on CMC regulatory issues.
- Demonstrated excellence in writing, presentation, and communication.