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1+ months

Director of Downstream Process Development

Kelly Services
Rockville, MD 20851
**Downstream Process Development Director**



Rockville, MD



Permanent, Direct-Hire Opportunity



Full-Time, Day-Shift





Kelly Science & Clinical has an excellent, direct-hire opportunity with a leader in the viral vector industry. This director is responsible for supervising 8-10 employees and reporting directly to the company CEO, alongside the upstream, GMP, and QA/QC teams. This role is responsible for leading process development. They offer a very competitive compensation/benefit/bonus plan in addition to additional growth opportunities.





**Responsibilities**




+ Oversee Downstream PD and train Downstream PD staff

+ Work with Quality Assurance and Quality Control teams to ensure full compliance with cGMP regulatory requirements

+ Work with Upstream PD while coordinating multiple client projects simultaneously

+ Author, review, and revise Batch Production Records in a timely fashion

+ Motivate, retain, and develop existing group members and recruit new staff to build a strong Downstream PD team

+ Contribute to continual improvement of all manufacturing documentation to ensure they are current, accurate, and clear

+ Communicate operational status regularly to the CEO, as required, at the appropriate level of detail

+ Other duties as assigned





**Qualifications:**




+ Ph.D. or M.S. in life sciences, Chemical Engineering, Biochemical Engineering, Biochemistry, or closely related field

+ At least 10 years of experience in industrial downstream process development and GMP manufacturing, especially in gene and cell therapy

+ Strong virus and protein purification experience is required (cell and gene therapy, virology, or biologics preferred)

+ Understanding of upstream bioreactor production and downstream purification operations such as centrifugation, ultra-filtration, and chromatography from pilot to GMP scale is required

+ Strong understanding of GxPs, process characterization/validation, and technology transfer is required

+ Experience working in a regulated environment (GMP and GLP) is a plus

+ Ability to work independently to lead a cross-functional team to support corporate goals

+ Ability to adapt to frequent change and thrive in a dynamic and entrepreneurial early-stage environment

+ Strong communication and organization skills, good working knowledge of MS office, data plotting and graphing software and DoE




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-08-17 Expires: 2020-10-17

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Director of Downstream Process Development

Kelly Services
Rockville, MD 20851

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