AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com .

SUMMARY:

AGC is searching for an experienced Scientist to join AGC Biologics expanding Quality Control team.  This scientist will lead method transfer and validation studies, commission new equipment, author and edit Quality system procedures, lead continuous improvement initiatives, and represent QC on project teams for clinical and commercial products. Working with QA, manufacturing, and analytical development groups, the QC scientist will be responsible for meeting QC timelines related to deliverables such as method transfer reports, test methods, change controls, and validation protocols and reports.

PRINCIPAL RESPONSIBILITES:

  • Manage the transfer and validation of test methods in support of drug substance release and stability testing.
  • Perform complex cell-based and ELISA based potency assays in support of release and stability testing as needed.
  • Author and revise test methods, validation protocols and reports, Quality system SOPs, and supporting documents.
  • Support equipment onboarding and validation lifecycle, including operation and maintenance procedures and software systems.
  • Drive change controls, investigations, CAPAs, and continuous improvement initiatives to successful completion.
  • Represent QC on project teams for clinical and commercial products with primary responsibility for validation of Drug Substance release assays.

KNOWLEDGE, SKILLS & ABILITIES:

  • Demonstrated in-depth knowledge of analytical methods across a wide range of technologies for the analysis of peptides/proteins. Special emphasis placed on cell-based potency methods, ELISAs or other plate based assays.
  • Proven scientific and technical ability to design and execute method development and validation experiments; analyze and present data; author and review protocol and reports, in support of regulatory submissions.
  • Demonstrated deep knowledge and experience of cGMP and the regulatory requirements for pharmaceuticals.
  • Must be a highly motivated and self-driven individual with the ability to work independently, and multi-task under aggressive timelines to support department and business objectives
  • Excellent analytical, technical writing, communication and data management skills
  • Ability to understand analytical/technical data.
  • Good organizational skills with attention to detail.
  • Ability to interact constructively with co-workers.

EDUCATION/EXPERIENCE:

  • BS in Life Sciences discipline such as Biochemistry, Chemistry, Biology or related field required
  • Minimum of 8+ years of experience in the biotechnology or pharma industry with experience in biologics
  • A strong background in method development, qualification and validation is highly desired. A background in quality control testing related to Biopharmaceuticals is required
  • Experience working in a QC environment.
  • Experience with relevant analytical lab equipment and computers

#LI-BB1

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances

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