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 and cell and gene therapies. 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:

The Director, Analytical Development and Testing provides leadership for analytical method development and analytical testing for clinical and commercial products.  In addition, this position provides direction for method qualification, validation, and transfer activities as well as specification setting associated with Quality Control testing of our GMP products.  The ideal candidate will be an expert in technical problem-solving and developing inter-departmental relationships.

 

PRINCIPAL RESPONSIBILITIES:

  • Provides strategic leadership and technical expertise for the successful management of Analytical Development (AD) and Quality Control (QC) Biochemistry functions
  • Lead and manage activities of AD and QC Biochemistry personnel
  • Hire, coach, mentor, and develop a team of professionals
  • Lead analytical method definition and development required for testing of intermediates, drug substances, and drug products
  • Direct analytical method qualification, transfer, and validation activities
  • Ensure the efficiency and effectiveness of activities related to in-process, lot release, and stability testing
  • Lead the design, implementation, and continuous improvement of laboratory systems that are technically sound, promote effective and efficient operations, and comply with company standards and regulatory requirements
  • Represent AD and QC on product teams and prepare/present data to internal and external clients
  • Act as subject matter expert for QC GMP operations during audits and regulatory inspections
  • Establish appropriate strategies for analytical method activities that are phase-appropriate and meet required timelines
  • Solve highly complex problems and lead others to solve issues of diverse scope

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Excellent leadership skills
  • Ability to communicate complex ideas and guide/persuade others
  • Strong understanding of scientific concepts in multiple analytical areas
  • Ability to use sophisticated analytical thought to understand and analyze complex analytical/technical data and implement solutions
  • Strong understanding of ICH guidelines, compendia, and regulations related to GMP production and testing of biologics
  • Ability to interact constructively with coworkers and other departments
  • Excellent organizational skills, excellent attention to detail, and ability to multi-task
  • Working knowledge of MS Word, Excel and PowerPoint

 

EDUCATION/EXPERIENCE:

  • BS/BA in Biology, Biochemistry, Chemistry or other biological science required; MS or PhD preferred
  • Minimum of 12+ years of experience in the biotechnology or pharma industry with experience in biologics
  • Extensive previous managerial experience required
  • Demonstrated expertise with a range of analytical techniques such as flow cytometry, ELISAs, qPCR, ddPCR, and cell based assays
  • Experience with relevant analytical lab equipment and computers

Equivalent education and experience may substitute for stated requirements

 

Compensation range for this position: $171,250-$205,500 commensurate with experience 

 

 

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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