Engineer, Process Development

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.

 
Major Responsibilities  

• Manage manufacturing technical support for developing and revising Manufacturing Batch Records for GMP and non-GMP products:
  • Creating Process SOPs to support Manufacturing Batch Records
  • Support components, consumable and raw material inventory by ensuring adequate quantities and availability
• Support manufacturing process development activities for GMP and non-GMP products:
  • Includes equipment assessment, and recommendations
  • Collaborating with Senior Manufacturing/Development/Technical peers, Sales, Quality, and Operational Departments
  • Procedure development and technology transfer

• Manage the EM activities and requirements:
  • Personnel assignment
  • Media availability and inventory
  • EM equipment tech support (collaborate with Development Scientist, Quality and Vendors)
  • Manage EM data trending requirements
• Formulate, fill and finish Akron manufactured products, including cryopreservation media, cell culture media, and supplements.

• Participates in the design and execution of investigations and experiments associated with development, improvement and scaling up manufacturing process.
• Creates and environment that encourages problem solving at the individual and team level.
• Takes an active role in process validation.
• Trouble shoots problems associated with process development/production/ including data analysis and internal record keeping.
• Utilizes formulas, work instructions or equivalent to monitor the production process which may reference related documents such as engineering specs as applicable.
• Inspect and test incoming material and in-process product as detailed in our SOPs, SDS sheets or working instructions to help ensure that our suppliers and our production process complies with established specifications.

 

• Perform general preventive equipment maintenance.  Contribute to maintaining lab and equipment cleanliness.
• Conducts in-house testing of products used for stability studies, parallel correlation studies and the general Laboratory and Instrumentation Maintenance.

• Maintains current knowledge of developments related to fields of product recovery and purification.
• Assists in the recommendation of new methods for manufacturing and testing efficiency
• Performs duties in accordance with established laboratory standards. Evaluates, troubleshoots and solves routine problems. Interprets data based on knowledge and experience.
• Perform other duties as assigned.

  Requirements

• Master’s degree in life science.

• 3-5 years minimum relevant experience as a process engineer in a biologics manufacturing capacity.
• Experience in quality organizations supporting production, testing, release and distribution of cGMP products.
• High attention to detail with good time management and organizational skills.
• Ability to work well under pressure and prioritize assignments in a multi-task position. 
• Motivated and able to work independently.
• Excellent verbal communication skills and people/customer service oriented. 
• Basic knowledge of Word, Excel and Software Programs. 
• Requires a strong adherence to regulatory compliance and safety requirements, involving GMPs, SOPs and other related documents such as log book.