Director of Downstream Process Development job in Gaithersburg, USA

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Last Name*

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Job type: Permanent

Discipline: Senior/Director & VP, Good Manufacturing Practice (GMP)

Location: United States

This vacancy has now expired. Please see similar roles below...

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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