*Senior Project Manager, Global Engineering

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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 Senior Project Manager, Global Engineering primary responsibility is the management and execution of capital project related activities carried out within their assigned areas of responsibility. The Senior Project Manager is part of our newly formed global Project Management Office (PMO) for capital project delivery. As part of the PMO, the Senior Project Manager may directly oversee the delivery of large capital project and also assist site based project managers in best practices and techniques. This role functions in a cross-functional capacity providing direction, identifying/resolving issues, organizing work assignments for equipment/manufacturing rooms/people, etc. and encouraging collaboration between essentially all functional areas. This includes the management of internal company resources, (assets, financial and personnel), external professional engineering and design firms, etc.

PRINCIPAL RESPONSIBILITIES:

  • Manage the delivery of large ( $15M) projects
  • Acts as a liaison between Operations, Technical Services and Quality for key initiatives and projects that require manpower, rooms and equipment from the manufacturing area.
  • Monitor, analyze, and help control key metrics for areas and projects that are important to meet company objectives.
  • Lead teams to align projects, develop and execute plans, and deliver results.
  • Use best practices in project management and coach site based project managers in their use
  • Ensure all required company, site and FDA regulations with emphasis on cGMP and their applications are adhered to.
  • Track ongoing projects, including forecasting of internal/external resource utilization.
  • Prioritize projects and make critical decisions related to assigned projects with minimal guidance and oversight.
  • Perform activities required to lead projects independently and finished work is in the form of project plans, project documents, and executed deliverables.
  • Participate in the capital budget development process by proposing, justifying and prioritizing projects.
  • Manage and resolve technical issues or changes arising throughout project life cycle(s) while ensuring the overall project objectives of scope, cost and schedule are adhered to.
  • Manage site activities necessary for successful execution of project(s) and ensures these are completed as necessary to tie in with the overall project execution.
  • Prepare and deliver updates on accomplishment of project timelines.
  • Support facility and process design and startup.
  • Mentor the development of a cross-functional engineering team (mechanical, electrical, automation)
  • Assist with tech transfer of new Mammalian, Microbial, and Cell Therapy processes into the facility.
  • Ensure the project designs incorporate reliability and maintainability, coordinating input from internal stakeholders
  • Prepare project dashboards and presents key updates to Executive Team stakeholders

KNOWLEDGE, SKILLS & ABILITIES:

  • Experience delivering CAPEX projects of varying complexity from $15M to over $100M in value.
  • Experience with Cell and Gene Therapy, Mammalian, and / or Microbial manufacturing space design/construction
  • Knowledge of process transfer and scale up methodology.
  • Experience with GMP documentation, facility and equipment validation, and process optimization.
  • Knowledge of best practices in project management including Integrated Project Delivery, Agile, Lean, Kaizen processes
  • Excellent organizational skills with ability to multi-task and prioritize.
  • Expert in capital project controls fundamentals including budget & schedule management, change management and forecasting
  • Well versed in P6, MSProject, or similar project management tools.
  • Demonstrated proficiency with all Windows based programs, knowledgeable with any CMMS program
  • Excellent verbal and written communication skills; ability to communicate with multi-level audiences.
  • Demonstrated ability to develop and implement standard operating procedures (SOP’s) for project management at the global level.

EDUCATION/EXPERIENCE:

  • BS in Engineering (Chemical, Biotechnology, Mechanical, or Electrical) required; MS highly preferable.
  • Minimum of 10 years of relevant industry experience (Biotech / GMP manufacturing environment).
  • PMP certification recommended.
  • Lean / Six Sigma certification desirable
  • Prior experience with Cell and Gene Therapy equipment and processes desirable.
  • Experience with Upstream and Downstream unit operations (centrifugation, filtration, precipitation, chromatography, bioreactors, CIP/SIP, mass flow technology, etc.) desirable.
  • Experience in the design, construction, and validation of Biopharmaceutical CGT facilities, both manufacturing and support systems.
  • Project Management and coordination experience associated with the execution of capital projects in an industrial environment is required.
  • Experience managing a project team consisting of construction, equipment procurement / installation, CQV, MFG Readiness / Startup, and Tech Transfer oversight.
  • Experience writing reports for senior colleagues outlining new concepts, testing outcomes, and ongoing efficiency.
  • Demonstrated ability to develop and maintain clear and accurate documentation for project management
  • Equivalent education and experience may substitute for stated requirements

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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Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".

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Jobbet er oprettet på vores service den 3.2.2022, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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