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Director of Manufacturing

Company: Akron Bio
Location: Boca Raton
Posted on: May 28, 2023

Job Description:

Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team. This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.

General Responsibilities:

  • Provides leadership and direction to the manufacturing operations team to ensure that they meet their short to medium term goals, including day to day technical leadership activities.
  • Develop and implement the systems and processes needed to run the site effectively, leveraging existing knowledge and practices where necessary, but also incorporating external experiences and learning.
  • Responsible for designing, delivering and fostering the ongoing training and development of people, and operational processes.
  • This role will manage the linkage between the site's manufacturing function and QA, QC, and other departments to foster effective communication, technology transfer and achievement of goals.
  • Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of excellence.
  • Build a team, creating clear common purpose and promoting good team spirit.
  • Ensure that team members are appropriately trained, and that operating procedures and training material are available and current.
  • Manage people training, qualification and performance. Set job expectations and goals for individuals linked to team/site goals. Develop people.
  • Responsible for all aspects of manufacturing projects; support the project team by providing support on decisions & strategies etc. Collaborate with them to ensure the right decisions are made to meet project deliverables and strategic goals for the site.
  • Perform final review of documentation (Standard Operating Procedures (SOPs), Logbooks for completeness, clarity, accuracy and submit edits to documents for revision as required.
  • Responsible for ensuring product is manufactured in accordance with appropriate regulatory agency validation requirements, internal company standards, and current industry practices.
  • Responsible for compiling and analyzing trend data, preparing reports and making recommendations for changes and/or improvements.
  • Author deviations, change controls, CAPAs, and reports.
  • Support process development and optimization activities independently or with minimal guidance.
    • BS or MS in Biology, Biotechnology, Chemical Engineering or a related field is required.
    • 10 or more years of experience in manufacturing for biotech, biopharmaceutical (USP and DSP, Microbial preferred)
    • Demonstrated ability to lead and motivate in a team environment.
    • Demonstrated ability to influence peers and across functions.
    • Ability to work independently, self-sufficiently and pro-actively in the performance of work duties.
    • Ability to resolve conflict and promote good decision making among team members.
    • Solid understanding of the importance of and basic requirements of Regulatory agencies such as the FDA, OSHA and EPA.
    • Strong organizational skills and attention to detail.
    • Able to work effectively in a fast-paced, small company environment.
    • Self-motivated, self-disciplined and able to function independently as well as part of a team.
    • Coordinate activities across multiple departments to communicate about or resolve issues and non-routine equipment events.
    • Ability to represent organization in front of customers and inspectors when required.
    • Ability to lead GMP training for new and current employees.

Keywords: Akron Bio, Boca Raton , Director of Manufacturing, Executive , Boca Raton, Florida

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