Associate Scientist I - II, Biologics Drug Product Development

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 to support animal studies.
• Conduct clinical in-use studies to guide dose solution administration.
• Analyze data, interpret results and draw conclusions from multistage experiments; note significant deviations and propose relevant new experiments accordingly.
• Generate high-quality data based on sound scientific understanding and prepare formulation data summaries, technical reports, and scientific presentations.
• Support functional technical initiatives by investigating and developing novel experimental approaches and/or technologies in the field of drug product development.
• Maintain oversight of day-to-day laboratory activities; manage inventory of raw materials and drug product packaging and manufacturing supplies; coordinate ordering, shipping, and receiving.
• Associate Scientist I: Bachelor's degree in chemical engineering, biochemistry, pharmaceutical sciences or equivalent, with 0-3 years of relevant experience.
• Associate Scientist II: Bachelor's degree in chemical engineering, biochemistry, pharmaceutical sciences or equivalent, with 3-5 years of relevant experience.
• Experience in handling select agent and highly-potent-compounds is highly preferred.
• Prior experience with drug product manufacturing processes and lyophilization is required.
• Experience in CMC development, with a preference for protein formulation, drug delivery, or analytical functions.
• Candidates must demonstrate the technical ability to execute and troubleshoot experiments using rational and critical thinking. Must be highly organized and detail oriented.
• Hands-on experience with analytical techniques used in protein characterization and stability studies, such as HPLC, spectroscopy, HIAC, DLS, ELISA, and Karl Fischer, is preferred.
• Excellent verbal and written communication skills are required.
• A strong willingness to learn and apply new scientific techniques.
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• 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.
• AbbVie 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.
• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
• https://www.abbvie.com/join-us/reasonable-accommodations.html

Benefits

Additional Information

Position Description: The incumbent in this role will support the formulation 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 requires laboratory work in areas requiring select agents and highly-potent-compound 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 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.

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