Principal Research Scientist I Process Development
AbbVie
4 hours ago
On-site
North Chicago, IL
Operations
Responsibilities:
- Independently design and conduct critical experiments; implement and may innovate new experimental protocols/techniques for parenteral DP characterization to enable process scale-up.
- Interpret results from own multistage experiments, note significant deviations, and suggest/design/pursue relevant experiments.
- Perform tech transfer for parenteral DP from development scale-up to clinical/commercial scale.
- Support drug product manufacture at GMP facilities from clinical through PPQ and commercial batches.
- Apply scientific literature and theoretical frameworks to solve problems within scientific discipline in a timely manner.
- Author comprehensive, scientifically sound reports (e.g., development reports, risk assessments) serving as source documents for regulatory submissions; author portions of regulatory submissions to designated health authorities.
- Develop and maintain comprehensive project plans, timelines, and tech transfer strategies across phases (from phase II clinical through commercial).
- Lead cross-functional PDS&T product teams; represent the CMC team/PDS&T in interfaces with leadership, Operations functions, other AbbVie functions, and external partners; coordinate governance efforts (e.g., Product Performance Teams, gate reviews).
- Prepare/review submissions for registration and post-approval lifecycle management; serve as a peer reviewer and understand how regulatory submissions limit operational changes.
- Establish/foster partnerships with key customers and counterpart functions; identify and promote best practices among PDS&T CMC leads.
- Adhere to corporate standards for code of conduct, safety, appropriate handling of materials, controlled drug/radioactive compounds, GxP compliance, and animal care where applicable.
Qualifications:
- BS, MS, or PhD in chemical engineering, pharmaceutical sciences, chemistry, pharmaceutics, or related fields; typically 14+ years (BS), 12+ years (MS/equivalent), or 6+ years (PhD).
- Strong laboratory skills in manufacturing process development for monoclonal antibodies, antibody constructs/conjugates, or other parenteral formulations.
- Scientific problem solving, experimental design, and troubleshooting skills.
- Solid understanding of aseptic unit operations: bulk freeze-thaw, compounding/mixing, filtration, filling, and lyophilization for liquid and lyophilized products.
- Experience with laboratory documentation systems (including ELN) and demonstrated technical report writing; technical understanding/experience with small molecule product manufacturing, development, quality, and analytics.
- Knowledge and experience with FDA and global regulatory requirements for CMC issues.
- Ability to influence internal and external experts on CMC regulatory issues independently.
- Demonstrated excellence in writing, presentation, and overall communication.
- Independently design and conduct critical experiments; implement and may innovate new experimental protocols/techniques for parenteral DP characterization to enable process scale-up.
- Interpret results from own multistage experiments, note significant deviations, and suggest/design/pursue relevant experiments.
- Perform tech transfer for parenteral DP from development scale-up to clinical/commercial scale.
- Support drug product manufacture at GMP facilities from clinical through PPQ and commercial batches.
- Apply scientific literature and theoretical frameworks to solve problems within scientific discipline in a timely manner.
- Author comprehensive, scientifically sound reports (e.g., development reports, risk assessments) serving as source documents for regulatory submissions; author portions of regulatory submissions to designated health authorities.
- Develop and maintain comprehensive project plans, timelines, and tech transfer strategies across phases (from phase II clinical through commercial).
- Lead cross-functional PDS&T product teams; represent the CMC team/PDS&T in interfaces with leadership, Operations functions, other AbbVie functions, and external partners; coordinate governance efforts (e.g., Product Performance Teams, gate reviews).
- Prepare/review submissions for registration and post-approval lifecycle management; serve as a peer reviewer and understand how regulatory submissions limit operational changes.
- Establish/foster partnerships with key customers and counterpart functions; identify and promote best practices among PDS&T CMC leads.
- Adhere to corporate standards for code of conduct, safety, appropriate handling of materials, controlled drug/radioactive compounds, GxP compliance, and animal care where applicable.
Qualifications:
- BS, MS, or PhD in chemical engineering, pharmaceutical sciences, chemistry, pharmaceutics, or related fields; typically 14+ years (BS), 12+ years (MS/equivalent), or 6+ years (PhD).
- Strong laboratory skills in manufacturing process development for monoclonal antibodies, antibody constructs/conjugates, or other parenteral formulations.
- Scientific problem solving, experimental design, and troubleshooting skills.
- Solid understanding of aseptic unit operations: bulk freeze-thaw, compounding/mixing, filtration, filling, and lyophilization for liquid and lyophilized products.
- Experience with laboratory documentation systems (including ELN) and demonstrated technical report writing; technical understanding/experience with small molecule product manufacturing, development, quality, and analytics.
- Knowledge and experience with FDA and global regulatory requirements for CMC issues.
- Ability to influence internal and external experts on CMC regulatory issues independently.
- Demonstrated excellence in writing, presentation, and overall communication.