Senior Bioprocess Engineer, Downstream - REMOTE/HYBRID job in Marydel, USA

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Last Name*

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First Name*

Last Name*

Email*

Phone Number*

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Job type: Permanent

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

Location: United States

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

Proclinical is seeking to hire a remote / hybrid Senior Bioprocess Engineer, Downstream located in Maryland. This person will be responsible for providing technical support and expertise to SARS-CoV-2 commercial Drug Substance sites, leading technical investigations, process improvement projects, and interpretation of manufacturing process data trends.

Job Responsibilities:

Work closely with DS sites to provide subject matter expertise on downstream processing, chromatography, and filtration topics
Lead technical investigation teams to identify root causes of process and analytical deviations using sound problem solving methodology
Perform statistical analyses of manufacturing process data, identification and investigation of adverse trends
Assist with the writing and reviewing documents for INDs / regulatory section submissions
Author and review CMC, Regulatory, and Quality documents such as risk assessments and E&L, technical memos and reports, microbial control, viral control, and process control strategy documents

Skills and Requirements:

PhD with 5+ years of relevant industrial experience or BS/MS with 8+ years of relevant industrial experience, in Biochemistry, Microbiology, Biology, Chemical Engineering, or closely related field.
Knowledge of harvest technologies, chromatography, filtration, and viral removal/inactivation.
Experience owning quality investigations such as deviations and out of specifications.
Proven experience in collaborating in matrix teams in a technical environment
Strong project and/or investigation management skills and adept at working collaboratively with cross functional teams.
Strong interpersonal and communication skills.

If you are having difficulty in applying or if you have any questions, please contact Eloise Coly at (+1) 617-830-1627 or e.coly@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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