Director of Downstream Process Development

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Good Manufacturing Practice (GMP)
  3. United States
Gaithersburg, USA
Posting date: 24 Jul 2020
This vacancy has now expired

Proclinical is currently recruiting for a Director of Downstream Process Development with a with a leading biopharmaceutical company located in Gaithersburg, MD. As the Director of Downstream Process Development, you will play a key role in creating the overall strategy for downstream development processes across the company's product pipeline.

Job Responsibilities:

  • Lead a function responsible for the development of purification processes.
  • Identify and develop new technologies to improve purification capabilities.
  • Design effective experiments using a Design of Experiments approach, incorporating Quality by Design into the process characterization
  • Contribute towards scale up, characterization, and optimization of all programs.
  • Leading process validation activities and strategies including the evaluation of downstream process characterization plans
  • Participate in tech transfer to cross-functional groups and external partners
  • Manage direct reports including Scientists and Engineers.
  • Prepare and review process development reports, protocols and reports, CMC regulatory filings.

Skills and Requirements:

  • PhD or MS with experience in pharmaceutical, biologics, or vaccine product development
  • Strong expertise in process design and development of purification operations.
  • Strong understanding of FDA regulatory requirements
  • Knowledge and expertise in GMPs principle
  • Experienced in tech transfers
  • Ability to manage and develop a team

If you are having difficulty in applying or if you have any questions, please contact Alec Tooulas at (+1) 917-284-9670 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.