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Scientist I, Biologics Drug Product Development

External
Abbvie logoAbbvie · Irvine, CA
Full-timeOn-site1mo ago30+ days old, may be filled
ComplianceDocumentationHTMLLess
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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.

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.
  • 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 highly potent compounds within a Biosafety Level 2 (BSL-2) laboratory environment.
  • 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.
  • 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

Health insuranceDental insuranceVision insurance401(k)Paid time offPerformance bonus

Additional Information

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.


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