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 team is looking for a Process Validation Engineer. This position is responsible for taking the lead in developing and implementing the strategy for performing process validation for commercial product candidates within AGC Biologics. The Process Validation Engineer interacts extensively across the organization and with clients & regulatory agencies in support of the drug approval process.

PRINCIPAL RESPONSIBILITIES:

  • Creates and owns all aspect of Drug Substance Process Validation program; the PV program must be designed to meet expectations in accordance with FDA/EMA/ICH regulations/guidance.
  • Champions the development and implementation of new QbD platform in the Process Development operation
  • Develops and maintains strong relationships with Process Development, Manufacturing, QC and QA to support robust Process Validation platform. This will include providing support to the Manufacturing operation during batch execution.
  • Develops and maintains overall Process Validation Master Plan. Identifies support plans (e.g., bench scale characterization studies, mixing validation, etc.) required to execute at-scale Process Validation deliverables.
  • Develop and apply risk-based strategies for process validation throughout product lifecycle. This includes continuous process verification and control strategy establishment with associated enabling documents (i.e. validation or supporting technical studies).
  • Act as Subject Matter Expert (SME) in support of execution of Continued Process Verification programs and associated analyses and reports.
  • Review/author relevant technical sections of regulatory dossier or other communications to health authority.
  • Support PV initiatives globally, together with other PV professionals at our other sites.
  • Provides hands on support and technical project management in the execution and maintenance of the validation program, with support from the PD, Manufacturing, QC and QA groups.
  • Responsible for ensuring appropriate creation and review of characterization and validation protocols and reports.
  • Interacts extensively in a team environment with multi-disciplinary team from Manufacturing, QA, QC, PD, and Project Management groups.
  •  Deliver presentations to clients and regulatory inspectors during inspections/audits.
  • Recognized by colleagues as a technical expert for Process Validation.
  • Act as Process validation SME for regulatory inspections and other audits
  • As SME, Represents PV in projects/core team.

Knowledge, Skills & Abilities:

  • Must possess technical competency in process validation requirements.
  • Knowledge and understanding of current GMP regulations and industry standards regarding process validation, particularly in Biologics Drug Substance manufacturing, in compliance with FDA/EMA regulations and ICH guidelines.
  • Strong leadership skills are critical; demonstrated experience with project and personnel management skills are essential and be able to coach junior level members.
  • Candidate should have good mechanical aptitude.
  • Must be dependable, detail-oriented, organized, and be willing to perform both routine tasks and develop new skills

Education/Experience:

  • BS/MS/PhD degree in Microbiology, Biochemistry, Engineering or related degree required.
  • 8+ years of relevant industry experience.


Applicants must be authorized to work in the United States. If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply.

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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