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.
We are currently looking for a Downstream Process Transfer Manager to join the AGC Biologics team. This is an exciting opportunity to provide leadership and oversight of Downstream (Purification) Process Transfer from Process Development into Manufacturing, the implementation of new technologies and systems into GMP operations, and key aspects of the start-up of new manufacturing facilities. The ideal candidate will be an expert in technical problem-solving and developing interdepartmental relationships.
Lead Process Transfer activities from Process Development to Manufacturing, incorporating the application of Lean and Six Sigma methodologies to drive process improvement. This includes driving the entire effort of drafting and revising process transfer documents, facility/equipment fit modeling, raw material estimates, manufacturing batch records and sample plans.
Serve as a key representative on project teams to identify, define and provide user requirements for process equipment associated with multiple facilities for the manufacture of biotechnology APIs.
Develop standards supporting Process Transfer activities and serve as Subject Matter Expert to troubleshoot processes and equipment during investigations or cycle and process development on the manufacturing floor.
Drive event and process analysis via Root Cause Analysis.
Drive process improvement/design via Lean and Six Sigma methodologies.
Lead the engineering effort to acquire process equipment from design through procurement, installation and operational readiness, and associated required GMP documentation.
Prepare and present data associated with manufacturing processes to internal and external clients. May serve as the escort during Person-in-Plant activities.
Support Business Development activities by providing technical expertise for the development of responses to RFPs.
Provide mentorship, guidance, and training to downstream Process Transfer team, as well as high-level technical leadership to Manufacturing and other departments associated with GMP operations.
Additional responsibilities not listed may be required of this position.
KNOWLEDGE, SKILLS & ABILITIES:
Strong knowledge in the following systems: Pharmaceutical Utilities, Purification, Filling, Bioreactors, Automation, Sterilization, and Water Purification. Driver for process improvement/design via Lean and Six Sigma methodologies.
Must be self-motivated, organized and proactive in order to coordinate the multi-departmental tasks and deliverables (interaction with Process Development, Engineering, QA, QC, etc.)
Must possess strong technical aptitude including demonstrated experience applying scientific reasoning to solve complex problems.
Ability to work hours necessary to support production and/or maintenance activities.
Ability to lift up to 40 lbs. with assistance.
Ability to work in confined spaces and near operating equipment.
Ability to work in loud noise environments.
EDUCATION / EXPERIENCE:
Bachelor Degree in Science or related science or equivalent combination of education/work experience required.
Minimum of 10+ years' experience in biopharmaceutical manufacturing operations.
Minimum of 3+ years' experience in a leadership/management/supervisory role in Manufacturing and/or Process Engineering, with a preference toward pharmaceutical or other regulated industries.
Experience utilizing LEAN/SixSigma methodologies.
Experience bringing biotechnology equipment and processes from design through GMP operational readiness.
Experience in mentoring/development, change management, planning/organizing, managing execution, and revising the work plan for complex problems solved by cross functional teams.
Due to the nature of manufacturing, shifts can and will vary. Shift preference may not always be available upon request.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE
CMC Icos Biologics Inc.