Project Evaluations, Technical Manager

Company: AGC Biologics
Location: Longmont
Posted on: November 22, 2021

Job Description:

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 .

Summary

We have an opportunity for a Project Evaluations, Technical Manager to join the Manufacturing Science and Technology (MSAT) team at AGC Biologics. This is a critical function within MSAT, in support of Business Development, that is responsible in translating technical requests from potential/ current clients into a comprehensive project service proposal that accurately conveys AGC's technical capabilities and value proposition.

Principal Responsibilities Include

• Serve as technical single point of contact for Business Development and Business Operations for managing preparation of all proposals, proposal revisions and project change orders.
• Supports Business Development with client interfaces to review and respond to technical requests (i.e. request for information) and attend client facing meetings to represent AGC's technical capabilities.
• Support initial site visit hosting.
• Interfaces with other site subject matter experts for evaluation of technical and quality requirements requests, as required.
• Works with Finance and Business Development to deliver raw material cost/ BOM estimates, Project Change Order estimate, and CAPEX quotes.
• Enable site preparation and effectively present, as technical SME, in Global Business Development meetings, such as Price Approval Committee and Production Strategy meetings.
• Leads the evaluation of future state technical evaluations and new process/systems proposals, including scalability, to ensure continuous improvement mindset.
  Knowledge, Skills And Abilities
  
  • Must be self-motivated, organized and proactive.
  • Demonstrated ability to interface/communicate extensively with internal and external clients, including senior management.
  • Strong communication and technical skills necessary to interact with internal and external stakeholders, with an ability to obtain buy-in from all key stakeholders.
  • Well organized and resourceful with the ability to plan ahead, including the ability to identify and develop solutions
  • A track record of creating/presenting persuasive proposals, with ability to adjust style/content based on audience.
    Education / Experience
    
    • Bachelor's Degree in Engineering or Science-related field.
    • Technical expertise in drug substance manufacturing and process development services in the Biologics sector is a must. Minimum of 10 years primary biotechnology cell culture and/or recovery and purification experience, preferably in clinical/commercial GMP manufacturing.
    • Relevant experience in the CDMO industry with proposal development (or equivalent role) and best practices in workflow.
    • Strong leadership experience, with minimum 5 years supervisory / managerial experience
    • Must have experience with and demonstrated understanding of FDA, EMA, and ICH regulations for biologics.
      Compensation Range
      
      $110,600 - $143,800 per year
      
      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.
      
      LI-LH1

Keywords: AGC Biologics, Longmont , Project Evaluations, Technical Manager, Executive , Longmont, Colorado