The successful candidate will be an integral part of a fast-paced and rapidly growing group of scientists and engineers developing processes for the manufacture of adeno-associated virus (AAV) and other viral products. The individual will be responsible for developing a platform downstream process to support Homology’s product pipeline. Responsibilities will include multiple aspects of viral vector purification via centrifugation, chromatography and membrane filtration. In addition, the individual will devise, conduct and assist with formulation studies and analytical testing to support all aspects of downstream development. In this position the individual will perform scale-up studies, lead aspects of technology transfer to contract manufacturing organizations and represent the department on cross-functional program teams. Critical to this role is the ability to concisely interpret and summarize data and to be able to effectively communicate results through high quality technical reports and oral presentations.
Essential Functions and Duties
- Planning and execution of studies related to the recovery and purification of AAV from cell harvest through final formulation steps
- Design of processes with product purity, recovery and manufacturability in mind
- Pilot scale production of pre-clinical test articles
- Lead technology transfer to internal and external manufacturing organizations by generating development reports and providing on-site technical support
- Support of R&D groups via material production, testing and interpretation of results
- Mentorship and training of junior team members
- Preparation and presentation of development studies. Authoring of associated technical reports, including CMC sections for regulatory filings.
- A strong understanding of the fundamentals and scale-up of chromatographic and membrane separations is required.
- Hands-on experience with chromatography systems and filtration (TFF, NFF) apparatus is required.
- A thorough understanding of virus properties and experience with development of purification processes for AAV and other viral vectors is highly desirable.
- Experience with developing purification processes and transferring to clinical manufacturing facilities is highly preferred. Strong verbal and written communication skills are integral to this position.
Skills and Experience
- BS (8+ years), MS (6+) or PhD (3+) years of directly related experience
- Degree emphasis in Chemical Engineering, Biochemistry, Bioengineering, or related discipline preferred
- This is a hands-on position requiring conducting laboratory experiments, good laboratory notebook practices, and good writing skills
- An understanding of purification of biologics or more specifically viral vectors, including process scale-up and tech transfer
- Experience with scale-up of purification processes and technical transfer to internal and external manufacturing organizations
- Experience with high-throughput process development techniques and statistical design of experience (DoE) preferred
- Knowledge of GMP/ICH/FDA regulations
- Track record of completing deliverables within specified timelines
- Ability to work effectively in a cross-functional team
- Familiarity with executing analytical methods used to support biologics purification process development (e.g. SDS-PAGE, ELISA, HPLC, etc.)
- Self-motivated and a capability of working independently
- Excellent problem-solving abilities with the knowledge and experience to anticipate and resolve issues before they arise
Interested candidates should forward a cover letter and resume/CV to firstname.lastname@example.org.