Gene Therapy Scientist – Remote

Remote, California

2021-05-17

Gene Therapy Scientist – Remote

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

We actively support and promote people of various backgrounds, from race, religion and gender to geographical area, university, lifestyle and personality type. Proven Recruiting is minority-owned, majority women, and is a strong advocate for diversity and inclusion in the broader community.

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