Scientist I, Biologics Drug Product Development

Job Title

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 select agents for therapeutics and aesthetic use.

This position involves designing, executing, and reporting 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 areas requiring select agents access (i.e., Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with Abb Vie internal and applicable regulatory requirements. Abb Vie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.

• 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.

• Bachelor's Degree or equivalent education with a minimum 5 years of experience, or Master's Degree or equivalent education with a minimum 2 years of experience.
• Degree in pharmaceutical sciences, analytical sciences, or equivalent field in the biotechnology industry, preferred.
• Candidates must exhibit the technical ability to execute and troubleshoot experiments through rational and critical thinking. Candidates must be highly organized and detail oriented.
• Hands-on laboratory experience in biologics formulation development, drug product manufacturing processes incl. lyophilization and analytics is required.
• Hands-on experience working with highly potent compounds within a Biosafety Level 2 (BSL-2) laboratory environment.
• Experience developing bioassays is strongly preferred.
• Prior experience with fluorescence anisotropy, qELISA and HPLC is strongly preferred.
• 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.

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range.

This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our short-term incentive programs.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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