Akouosis seeking an innovative candidate to drive and lead the upstream processdevelopment for the manufacture of AAV-based gene therapies. The idealcandidate for this position is an experienced Scientist or Engineer with astrong background in AAV manufacturing technologies and an excellent trackrecord in gene therapy upstream process development. The successful candidatewould have experience in cell culture process scale-up, process optimization,and tech transfer for GMP manufacturing. The successful candidate will thrivein a collaborative, scientifically-stimulating, and fast-pace environment.
We are looking for someone who will:
- Drive and lead upstream process development of AAV production and technical transfer to internal / external GMP MFG.
- Implement and develop innovative vector production technologies based on current learnings in the field and QbD strategies.
- Generate and maintain appropriate cell and plasmid banks for use in development and GMP manufacturing.
- Develop protocols for vector production in shake flasks, wave bioreactors, and stirred tank bioreactors.
- Perform monitoring of cell viability/growth and cell culture metabolites from cultures.
- Develop intellectual property, publishing scientific papers, present at conferences and other tasks related to the company’s scientific and business interests.
- Provide scientific expertise and guidance in clinical AAV production, development and innovation.
- Author and review appropriate CMC documents for regulatory filings.
- Participate in internal project and external CMO teams as a subject matter expert.
- Demonstrate leadership and foster a team environment.
- Write, prepare and present technical data, technical reports and standard operating procedures (SOPs) for internal use and tech transfer.
- Manage a group of scientists focused on developing and implementing Akouos’s upstream production platform
- Degree in chemical engineering, biology, biochemistry, chemistry, biotechnology or a related field.
- PhD in relevant subject matter (e.g. cell culture production of protein biologics) with 3-5 years relevant process development experience or an MS with 5-8 years relevant experience.
- Previous experience with developing mammalian cell culture manufacturing processes is a must.
- Prior experience with HEK293 based AAV manufacturing processes is preferred.
- Proficient with aseptic techniques and the use of shake flasks, wave-based bioreactors, and stirred tank bioreactors at various scales.
- Prior experience with cGMP/cGLP regulatory guidelines related to pharmaceutical biologics development is a plus.
- Prior experience managing a team, co-ops or direct reports is desired.
- Prior experience with tech transferring to a cGMP facility is desired.
- The candidate must be well-organized, goal-focused, and detail-oriented.
- The candidate must have outstanding verbal and written communication skills.
- Abiltiy to lead and work independently in a collaborative, scientifically stimulating, fast-pace environment.
Job Type: Full-time
- relevant: 1 year (Preferred)