Gene Therapy Scientist – Remote

Remote, California

2020-10-18
  • The candidate should be experienced in the development and manufacturing of gene therapy products, ideally from clinical development through commercial licensure, with senior level experience in a CMC related role, especially as they relate to viral vector manufacturing.  
  • The candidate will serve as a Subject Matter Expert (SME) as well as a resource to other consultants in support of company efforts to provide CMC consulting services in the cell and gene therapy fields.  

 

Responsibilities:

·         The individual will be responsible for supporting DHC projects and must be comfortable being a viral vector and non-viral SME

·         The individual may perform business development to bring in new clients, help enhance the internal knowledge base and operational efficiencies, and mentor to staff

·         Personnel and project management will be required

·         This position will require client visits, on site person in plant at CMOs and contract vendor audits on a global basis.  Therefore, the ability to travel internationally is a pre-requisite and should be expected

 

Qualifications

·         Ph.D., or MS in bioprocessing, chemical engineering, vector biology, or biological sciences preferred

·         The ideal candidate for this position will have an in-depth knowledge and experience of small and large-scale cGMP production of AAV, Lentiviral, Retroviral and Adenoviral vectors, plasmids, and other non-viral vector delivery technologies

·         Minimum of 10 years’ experience in the biotechnology or pharma industry with a primary focus on upstream cell culture, downstream processing and fill finish operations for clinical and commercial viral vector manufacturing

·         In-depth and hands on experience with mammalian cell and microbial cell culture systems both a pilot scale and large scale, and different bioreactor production systems and scales, including disposable single use bioreactor systems

·         Validation of manufacturing process and controls

·         Experience of facility and production equipment design and validation, including IQ, OQ, and PQ

·         In-depth knowledge of FDA, EMA, GMP and ICH regulations

·         Ability to operate in a fast-paced, multi-disciplinary industrial environment

·         Strong presentation, written and oral communication skills

#LI – LJS

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