AGC Biologics are looking for our next Global Vice President, Engineering
 
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 Manufacturing Project Specialist will be responsible for identifying and executing projects that directly relate to process readiness, right first time execution, and improved compliance on the manufacturing floor and facility.

PRINCIPAL RESPONSIBILITIES

  • Support the implementation of new processes in close collaboration with Program Managers, Process Transfer/Process Development, Engineering, and Validation team
  •  Provide support to manufacturing staff for new equipment and processes.
  • Ensure process optimization and continuous improvement.
  • Identify new technology for new/current assets and assist with identifying user requirements, procurement, and implementation as needed.
  • Collaborate with engineering and validation teams to implement and qualify new equipment and controls.
  • Author and update quality documents, such as Standard Operating Procedures (SOPS) and other technical procedures.
  • Follow-up on production campaigns including client communication, review and approval of batch records, troubleshooting, handling of deviations and CAPAs.
  • Participate in customer meetings providing manufacturing updates.
  • Represent the interests of the Manufacturing team, serve in multidisciplinary project teams, working closely with other team members in a cooperative fashion to ensure project progression
  • Work closely with Manufacturing operations and QA team to drive CAPAs to timely closure
  • Provide support in quality system programs such as Deviation, CAPA, Change Management
  • Serve as liaison between multiple groups including Manufacturing, Quality, and Process Development

KNOWLEDGE, SKILLS AND ABILITIES

  • Ability to interact constructively and influence peers and support groups
  • Prior experience technical writing and in a manufacturing environment preferred
  • Must have the ability to work in a fast paced, high workload environment, and be able
  • manage multiple projects and objectives for on-time delivery. Must work well on a team, and
  • able to trouble shoot and problem solve in a cross functional team setting. Must be proactive
  • action oriented, and have the ability to adapt to change. Must be able to identify and flag risks in a timely manner to keep deliverables on track.
  • Strong written and verbal communication skills are required. Ability to read and comprehend
  • complex subjects. Strong typing and computer skills, including efficiency using Microsoft Office
  • Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems.
  • Ability to understand and apply GMP regulations as they relate to manufacturing

EDUCATION/EXPERIENCE

  • BA/BS degree in a science related discipline preferred or combination of education and work experience
  • 4+ years’ experience in bioprocessing manufacturing, preferably in large-scale operations
  • Expertise in GMP and bioprocessing knowledge 

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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