Scientist, Process Development (Molecular Biology)

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Job description

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:

• Lead and participate in ongoing technology development efforts in plasmid production, improving the efficiency and productivity of our platform processes.
• Lead, contribute, and perform experiments for analytical methods development with emphasis in molecular biology techniques.
• Establish and executes the detailed development project plan including analytical development, assay development, optimization, qualification, and tech transfer.
• Provide technical expertise and actively troubleshot and improve methods.
• 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. scope definition and experimental design of development activities (process development and bioassay) through respective project leaders, aligns goals of the project with MSAT, manufacturing (MFG) and Quality Control (QC), obtains buy-in from client and removes obstacles to successful completion.
• 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.

Qualifications:

• Master's Degree in Biological Sciences; Molecular Biology, Microbiology, Biomedical Sciences and related field required.
• 4+ years minimum relevant experience. Biotech industry experience highly preferred.
• Experience in Molecular and Microbiology techniques.
• Proficiency in densitometry, ELISA, PCR, qPCR, sequencing, agarose gel techniques, DNA extraction, purification, and quantification.
• 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.
• Experience with cGMP requirements.
• Experience in technology transfer to QC.

EOE/DFW