Scientist I, Biologics Drug Product Development
About The Position
The incumbent in this role will support the formulation and process development of protein biologics from early development (pre-clinical/First-In-Human candidates) through commercialization, with a specific focus on highly potent compounds for therapeutics and aesthetic use. This position involves designing, executing, and reporting of laboratory experiments to advance the development of stable and effective biologic formulations. The incumbent will collaborate across multidisciplinary teams and contribute to solving technical challenges in both formulation and process optimization, to enable successful clinical and commercial progression of therapeutic biologics. This position requires laboratory work in Biosafety level 2 laboratories. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.
Requirements
- BS with a minimum of 5 years or MS with a minimum of 2 years of experience in pharmaceutics, pharmaceutical sciences, chemical engineering, analytical sciences, or equivalent field in the biotechnology industry.
- Candidates must exhibit the technical ability to execute and troubleshoot experiments through rational and critical thinking.
- Candidates must be highly organized and detail oriented.
- Strong organizational and documentation skills; ability to maintain accurate experimental records and reports.
- Effective verbal and written communication skills with the ability to work collaboratively in cross-functional teams.
Nice To Haves
- Hands-on laboratory experience in biologics formulation development, drug delivery, drug product manufacturing processes, lyophilization or analytical functions is preferred.
- Prior hands-on experience working with neurotoxins or highly potent compounds within a Biosafety Level 2 (BSL-2) laboratory environment.
Responsibilities
- Execute formulation composition and drug product process development studies for sterile liquids, lyophilized, and pre-filled dosage forms.
- Manufacture drug product formulation batches for evaluating formulation stability and/or for animal studies.
- Conduct clinical in-use studies to guide dose solution administration.
- Perform analytical testing and characterization of biologic samples, assessing critical quality attributes to support formulation and process decisions.
- Interpret results and draw conclusions from multistage experiments; note significant deviations and propose relevant new experiments.
- Thoroughly document experimental procedures, results, and interpretations in laboratory notebooks and reports, ensuring compliance with company and regulatory standards.
- Generate high-quality data based on sound scientific principles and prepare formulation data summaries, technical reports, and scientific presentations.
- Participate in the evaluation, implementation, and ongoing improvement of new and existing technologies, techniques, and equipment to continuously enhance formulation and process development.
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- short-term incentive programs
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
