Process Development Scientist III (Upstream)
AavantiBio is seeking a highly motivated scientist to join our growing team and advance gene therapy research programs in rare disease. The position will support Upstream Process Development (USPD) activities. The individual will work with the Director of Process Development to plan, and execute USPD experiments with good documentation practices (GDP), review executed records related to production activities, write or review discrepancies, investigations, etc. related to tasks. Will be expected to prepare, modify, and review documents (SOPs, batch records, etc.) required for USPD tasks, and to aid in maintaining the equipment in the USPD lab suites.
Responsibilities – Including but not limited to:
- Act as the Subject matter expert on USPD activities including designing, planning and execution of experimental plans for unit operations spanning cell thaw thru product clarification
- Execute, write, and review experimental plans, batch records or other related development documents
- Maintain, calibrate, and perform preventative maintenance of equipment to maintain efficient and safe operations
- Preparation of materials and reagents to execute production runs
- Communicate and collaborate with team members and leadership team
- Ensure materials with GMP-compatible materials and equipment are available to develop processes, produce toxicology material and transfer to cGMP operations
- Support the troubleshooting effort in support of cGMP investigations for OOS or other deviations.
- Ensure USPD team follows GDP, Good Laboratory Practices (GLP), and other best practices
- Drive to completion investigation reports quickly and efficiently
- Provide support in technical transfer of processes to process development to external manufacturing facilities or CDMOs
- Act as SME for technical review of CDMO provided documentation and investigations
- Work to maintain, develop and lead safety culture through programs to identify and address concerns of staff.
- Mentor and coach new or less experienced members to the team
- Other duties as assigned
Experience, Knowledge and Skill Requirements:
- Ph.D. in Biology, Chemistry, Life Sciences, or related field with a minimum of 5 years of experience
- MS in Biology, Chemistry, Life Sciences, or related field with a minimum of 6 years of experience
- B.S. in Biology, Chemistry, Life Sciences, or related field and >8 years of industry experience Degree requirements can be lessened by experience
- Relevant experience in small- and large-scale cell culture techniques required and virus production utilizing transfection and/or infection-based systems, is a plus
- Adherent and suspension experience is required and ability to utilize multiple platform technologies is
- Experience with equipment related to USPD, is expected including bioreactors, automated cell counters, metabolite analyzers, pumps, pressure monitors, ,
- Knowledge of downstream processing and analytical assays, preferred
- Excellent communication skills, including technical writing ability
- Ability to work in fast paced environment and managing ambiguity and uncertainty
- Work effectively independently and with a cross-functional teams
About the Company
Biotechnology – 30-50 employees
AavantiBio is a clinical-stage biopharmaceutical company committed to developing and commercializing novel gene transfer and gene editing therapies for the treatment of rare and ultra-rare genetic diseases. The company is rapidly building a diverse portfolio of gene transfer and gene editing therapies to target debilitating genetic diseases for which the unmet medical need is high and for which there are typically no approved therapies treating the underlying disease.
Headquartered in Cambridge, MA with an additional location in Gainesville, FL, AavantiBio is looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene transfer therapy.
Come join our team!
EQUAL OPPORTUNITY EMPLOYER
is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.