Technician, Manufacturing

Akron Bio - Boca Raton, FL

Full-time - Entry Level

Boca Raton, FL

About the position

The Technician, Manufacturing role at Akron Biotech involves providing essential support in the development and manufacturing operations of cell therapy components and raw materials. This position plays a critical role in ensuring high-quality industrial-scale solutions for advanced therapy development and commercialization. The technician will be responsible for various tasks including formulation, aseptic filling, documentation maintenance, and troubleshooting within a cleanroom environment.

Responsibilities

• Provides development and manufacturing operations support including the formulation and aseptic filling of Cryopreservation media, cell culture media, and cell culture supplements.
• Executes and maintains documentation relating to manufacturing.
• Supports all technical writing requirements for manufacturing/operations.
• Authors and revises manufacturing batch records, SOPs, work instructions, validation/qualification protocols, forms, logbooks, technical reports, CAPAs, change controls and any other document that may apply.
• Formulates, fills and finishes Akron manufactured products, including cryopreservation media, cell culture media, and supplements.
• Performs aseptic processes in a controlled or cleanroom environment.
• Performs in-process testing of products using general laboratory equipment/instrumentation.
• Utilizes formulas, work instructions or equivalent to monitor the production process.
• Performs experiments associated with development, improvement and scaling up or optimization of manufacturing and development processes.
• Troubleshoots problems associated with equipment, process development/production including data analysis and internal record keeping.
• Performs Environmental Monitoring activities as required.
• Performs the cleanzone cleaning as required.
• Maintains current knowledge of developments related to product recovery and purification processes.
• Performs duties in accordance with established laboratory standards.
• Evaluates, troubleshoots and solves routine problems.
• Interprets data based on knowledge and experience.
• Performs process validation and equipment qualification as required.
• Performs general equipment preventive maintenance.
• Contributes to maintaining lab and equipment cleanliness.
• Supports and coordinates deviation investigations and implementation of change controls or robust corrective and preventative actions.
• Supports finished product labeling, raw material aliquoting and, re-labeling requirements when necessary.
• Performs other duties as assigned.

Requirements

• BS or MS in Biology, Chemistry, Bioengineering or a related field + 2 years minimum experience working in a life science manufacturing role.
• Detail-oriented 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 Outlook, Word, Excel and Software Programs.
• Requires a strong adherence to cGMPs regulatory compliance and safety requirements, SOPs and other related documents such as SDS and manuals.

Benefits

• 401(k) matching
• Dental insurance
• Disability insurance
• Gym membership
• Health insurance
• Life insurance
• Paid holidays