About Us
Akron Bio is a rapidly growing company transforming the advanced therapy development and commercialization landscape with high-quality industrial scale solutions.
Job Summary
We are seeking a highly motivated professional to oversee technical transfer, implementation, and execution of upstream and downstream processes at our Sarasota Akron BioManufacturing site.
Key Responsibilities:
* Maintain procedures and business processes for technology transfer from clients to Akron BioManufacturing and from process development to cGMP manufacturing.
* Oversee new production process introduction using proper technology transfer approach and perform risk assessments and analysis.
* Ensure successful implementation of new processes in process development laboratories and evaluate process maturity for transfer into cGMP production.
* Assist with design of upstream and downstream process development experiments.
* Actively assist in troubleshooting Upstream and downstream processes as needed.
* Ensure new processes are developed using cGMP compliant raw materials.
* Lead readiness activities for unit operations such as bacteria thaw and incubation, fermentation, centrifugations, depth filtrations, etc.
* Create, review, and approve Manufacturing Batch Records.
* Review and approve SOPs, Work Instructions, and Batch records.
* Develop Process Performance Qualification and Process Validation guidelines.
* Own deviation investigations and implementation of change controls.
* Provide subject matter expert input to support continuous improvement initiatives.
Requirements:
* MS or BS in Biology, Chemistry, Bioengineering, or related field with at least 5 years' experience in life science process development or manufacturing.
* Demonstrated biologics expertise in upstream or downstream processing and operations.
* Expertise with technical transfer and scale-up required.
* 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 preferred.
* Detail-oriented with good time management and organizational skills.
What We Offer:
A comprehensive benefits package including competitive compensation, 401K plan, PPO and HMO medical insurance, company paid dental and vision insurance, and more.