Bioprocess Engineer (Biotech/Pharma)

Akron Bio 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.

This position is responsible for overseeing the technical transfer, the implementation and execution of upstream and downstream processes at the Sarasota Akron BioManufacturing site. This position will act as site manufacturing sciences and technology subject matter expert leading development and cGMP activities in collaboration with Process Development and Manufacturing departments.

Responsibilities

• Maintain the procedures and business processes for technology transfer from client (external tech transfer) to Akron BioManufacturing and from process development to cGMP manufacturing (internal tech transfer).
• Oversee new production process introduction using proper technology transfer approach.
• Perform risk assessments and risk analysis regarding new project introduction and existing campaign.
• Development risk and gap assessment matrix for new products and processes.
• Ensure the successful implementation of the new processes in the process development laboratories and evaluate process maturity for transfer into cGMP production.
• Assist with the design of upstream and downstream process development experiments.
• Actively assist in troubleshooting Upstream and downstream processes as needed in collaboration with process development scientist and manufacturing engineers.
• Ensure new process are developed using cGMP compliant raw materials while working with the Quality Assurance department.
• Lead readiness activities for unit of operations, such as, bacteria thaw and incubation, fermentation, centrifugations, depth filtrations, diafiltration/ultrafiltration, chromatography, formulations, cell banking, final fill, aseptic manipulations, etc. Lead execution at the production floor.
• Create, review, and approve Manufacturing Batch Records.
• Review/approve SOPs and Work Instructions (WI) and Batch record.
• Review and approve Bill Of Materials (BOM) and BOM templates, and Bill Of Equipment (BOE).
• Develop Process Performance Qualification (PPQ) and Process Validation guidelines and Oversee activities, as needed.
• Own deviation investigations and implementation of change controls, CAPAs and other QMS-activities.
• Provide subject matter expert (SME) input to support continuous improvement, capital, and corporate initiatives.
• Responsible for compiling and analyzing trend data, preparing reports and making recommendations for changes and/or improvements.
• Performs other duties as assigned.
• Assist with multi-disciplinary cross-functional projects.

Requirements

• MS or BS in in Biology, Chemistry, Bioengineering or a related field with at least 5 years’ experience working in a life science process development or manufacturing role (biopharmaceutical fermentations and purifications).
• Must have demonstrated biologics expertise in upstream or downstream processing and operations and have strong knowledge of industry best practices.
• Expertise with technical transfer and scale up is required.
• Experience with single use technology applicable to technologies such as: fermentation, filtration, chromatography, etc.
• Prior experience in cGMP manufacturing, operation of process equipment and aseptic technique.
• Proven technical expertise in upstream or downstream biologics.
• Data analytics experience with JMP or similar program is preferred.
• Detailed-oriented with good time management and organizational skills.
• Ability to prioritize assignments in a multi-task position.
• Motivated and able to work both independently and as part of a growing manufacturing team.
• Excellent verbal communication skills.
• Must be able to work a flexible schedule as this is a biomanufacturing environment.
• Execute tasks in a timely manner without direct supervision.

In addition to competitive compensation, we offer a comprehensive benefits package including:

• 401K plan with employer match
• PPO and HMO medical insurance plan availability
• Company paid dental and vision insurance
• Company paid short-and long-term disability
• Company paid life insurance
• Company paid holidays
• Generous paid time off allowances
• Employee referral bonus
• Employee gym reimbursement program
• Employee recognition program

EOE/DFW