Director of Downstream Process Development

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 a.tooulas@proclinical.com.

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.

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