Senior Scientist I
AbbVie
5 hours ago
On-site
North Chicago, IL
Clinical Research and Development
Responsibilities:
- Independently design and conduct critical experiments to further project goals; implement and may innovate new experimental protocols/techniques for parenteral drug product (DP) characterization to enable process scale up.
- Interpret results from multistage experiments, note significant deviations, and suggest/design/pursue relevant experiments.
- Perform tech transfer activities 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.
- Understand relevant scientific literature and apply theoretical frameworks to solve problems within the scientific discipline.
- 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 development/scale-up tech transfer strategies (e.g., from Phase II through commercial).
- Prepare and review submissions for product registration and post-approval lifecycle management; serve as a peer reviewer and understand how submissions limit operational changes.
- Establish and foster partnerships with key customers and counterpart functions to facilitate collaboration; identify and promote best practices among PDS&T CMC leads.
- Adhere to corporate standards for safety, material handling, controlled drug/radioactive compounds, GxP compliance, and animal care where applicable.
Qualifications:
- Bachelors, Masters, or PhD in chemical engineering, pharmaceutical sciences, chemistry, pharmaceutics, or related disciplines with 10+ (Bachelors), 8+ (Masters), or 0–3+ (PhD) years of relevant industry experience.
- Strong laboratory skills and experience 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 manufacturing unit operations (e.g., bulk freeze-thaw, compounding/mixing, filtration, filling, lyophilization for liquid and lyophilized products).
- Experience with laboratory documentation systems (including ELN) and 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.
- Demonstrated excellence in writing, presentation, and overall communication.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible for short-term incentive programs.
Application instructions:
- None provided in the job description text.
- Independently design and conduct critical experiments to further project goals; implement and may innovate new experimental protocols/techniques for parenteral drug product (DP) characterization to enable process scale up.
- Interpret results from multistage experiments, note significant deviations, and suggest/design/pursue relevant experiments.
- Perform tech transfer activities 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.
- Understand relevant scientific literature and apply theoretical frameworks to solve problems within the scientific discipline.
- 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 development/scale-up tech transfer strategies (e.g., from Phase II through commercial).
- Prepare and review submissions for product registration and post-approval lifecycle management; serve as a peer reviewer and understand how submissions limit operational changes.
- Establish and foster partnerships with key customers and counterpart functions to facilitate collaboration; identify and promote best practices among PDS&T CMC leads.
- Adhere to corporate standards for safety, material handling, controlled drug/radioactive compounds, GxP compliance, and animal care where applicable.
Qualifications:
- Bachelors, Masters, or PhD in chemical engineering, pharmaceutical sciences, chemistry, pharmaceutics, or related disciplines with 10+ (Bachelors), 8+ (Masters), or 0–3+ (PhD) years of relevant industry experience.
- Strong laboratory skills and experience 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 manufacturing unit operations (e.g., bulk freeze-thaw, compounding/mixing, filtration, filling, lyophilization for liquid and lyophilized products).
- Experience with laboratory documentation systems (including ELN) and 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.
- Demonstrated excellence in writing, presentation, and overall communication.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible for short-term incentive programs.
Application instructions:
- None provided in the job description text.