Director of Manufacturing
Company: Akron Bio
Location: Boca Raton
Posted on: May 28, 2023
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.
- 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
- 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
- Build the organization with the necessary capability, capacity
and culture to operate this facility to the highest standards of
- Build a team, creating clear common purpose and promoting good
- Ensure that team members are appropriately trained, and that
operating procedures and training material are available and
- Manage people training, qualification and performance. Set job
expectations and goals for individuals linked to team/site goals.
- 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
- 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
- Demonstrated ability to influence peers and across
- 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
- 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
- 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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