Scientist, Upstream 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 and gene therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.
Key responsibilities include:
Key responsibilities include:
- Lead and participate in on-going technology development efforts in plasmid production, improving the efficiency and productivity of our platform processes.
- Highly involved in the scale-up and technology transfer of manufacturing processes for the production of commercial-scale plasmids for cell and gene therapy.
- Contribute to the design, execution, and analysis of studies to optimize processes
- Provide technical expertise and be proactive in resolving process problems.
- Assist in creation of process design specifications and conduct appropriate studies to establish and demonstrate that the process meets its pre-determined processing specification.
- Participate in strategic planning for the direction of the CMC organization by making presentations to senior management, providing periodic progress updates on projects and proposals for new technology development initiatives and advanced data analytics.
- Lead and assist with the design and execution of experimental protocols to maximize process understanding
- Represent the department on project teams when required.
- Plan and prioritize activities to meet multiple project timelines, financial milestones and personal objectives
- Manage activities of laboratory technician and associates.
- Responsible for authoring and reviewing technical reports, SOPs, protocols, technology transfer documents, and CMC sections in regulatory filings.
- Development, optimization and characterization of robust upstream manufacturing processes based upon quality by design (QbD) principles.
- Lead fermentation process development and improvement including media optimization, strain development and characterization, master cell banks generation and characterization.
- M.S. or PhD in Biological Sciences; Molecular Biology, Microbiology, Biomedical Sciences and related field required.
- 2+ years minimum relevant experience in biotech with PhD, 5+ years of relevant experience with M.S.
- Microbiology background preferred.
- Proficiency in microbial fermentation and expertise using bioreactors and associated software required.
- 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.
- Hands-on experience with process scale-up/process characterization.
- Experience with cGMP requirements.
- Experience in technology transfer to manufacturing.
- Very good understanding of small-scale model qualification and challenges faced during scale-up.