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:

AGC Biologics is looking for a QA Senior Scientist to provide Quality support for a biologics manufacturing plant startup, implementing robust and compliant processes and systems required for commercial manufacturing operations. The ideal candidate will possess a scientific background to help in the resolution of issues associated to the Manufacturing or any other critical process at AGC Biologics. The Senior Scientist will take a leadership role in solving extremely complex problems, such as critical Deviations and Change Records, which involve cross-functional teams outside of the QA department and clients. They will act as the point of contact for critical investigations, ensuring all reports performed are scientifically sound and well written. They will provide guidance to others in the documentation and submission of investigations for approval.

 

PRINCIPAL RESPONSIBILITIES:

  • Demonstrates success using compliance knowledge, creativity, and regulatory perspectives to solve problems, especially those associated with critical deviations.
  • Exercises independent judgment in interpreting and applying regulations to GMP systems. May make recommendations for QA policies and procedures. Interprets complex regulations and guidelines critical for advancing and improving the QA systems.
  • Leads efforts to identify and implement processes and procedure optimization to facilitate compliance.
  • Directly involved in the execution and closure of investigations and the implementation of the associated Corrective Actions/Preventive Actions (CAPAs).
  • Takes a leadership role in planning and implementation of long range quality goals as they relate to the corporate goals.
  • Accountable for decisions and results that promote the efficiency of the processes at ACG and increase the customer satisfaction level with the internal and external clients.
  • May lead projects or represent QA interests in multidisciplinary project teams. Works closely with other team members in a cooperative fashion to ensure project progression. May act as an advisor to multiple project teams.
  • Supports and provides leadership to the direction and decisions of AGC Biologics project/transfer teams.
  • Responsible for making recommendations and decisions in accordance with federal and international regulatory requirements and industry standards.
  • Ideally, but not strictly required, the candidate should possess scientific background and expertise in areas such as Quality Control (i.e. testing profiles and Laboratory Investigations) and be familiarized with the Manufacturing and Development processes.
  • The candidate should be familiar with the Operational Excellence tools (i.e. Kaizen, Value Stream Mapping, etc.), basic Risk Management techniques and their applicability in the pharmaceutical industry.

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Strong technical and analytical understanding of Biologics Manufacturing and testing.
  • Ability to articulate compliance strategy and rationale via oral and written communication techniques. Good organizational skills. Demonstrates leadership in areas of teamwork, conflict resolution, and problem-solving.
  • Advanced knowledge of regulatory principles and concepts as they relate to Operations and GMP.
  • Advanced knowledge of GMP and regulatory submission requirements.
  • Knowledge in Operational Excellence and Risk Management.

 

EDUCATION/EXPERIENCE:

  • BA or BS with at least 12 years QA-related experience or equivalent work experience.
  • Experience with interpretation and application of regulatory principles, which drive QA strategy.

 

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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