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San Diego, CA: MSAT Lead (229794)

Employer
Black Diamond Networks
Location
Stratford, California, US
Salary
Competitive
Closing date
Jan 15, 2022

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Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Other
Salary Type
Salary
Employment Type
Full time
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Job Description

Our client is a CDMO that focuses on process development and commercial supply for plasmid-based therapeutics developers by providing critical raw materials, drug substances and drug products. They are seeking an MSAT Lead for a 6+ month contract. This individual will lead a cross functional team on technology transfers, process performance qualification for a commercial run, process characterizations, support downstream development activities and other tasks related to plasmid DNA manufacturing.

Required Experience
  • B.S in the life sciences, engineering, or equivalent technical field required; 6+ years of experience, or MS and 4+ years of relevant experience or a PhD and 2+ years of relevant experience, preferred
  • Demonstrated manufacturing technical support experience in a Microbial, Viral Vector, Biologics, or vaccine production
  • A sound understanding of pDNA production and analytics, scale-up principles, process validation, and regulatory strategies.
  • Hands on experience in PD, GMP MFG, or Manufacturing Sciences in microbial or mammalian biologics manufacturing for Biopharma or other highly regulated environment
  • Experience with cell culture-based manufacturing, tech transfer, investigations, and process validation of commercial-scale human therapeutics; ideally, with single-use technology systems
  • Experience working in or with a CDMO
  • Knowledge of plasmid / microbial manufacturing processes and Single Use equipment
  • Understanding and/or knowledge of change control and performing process impact assessments.
San Diego, CA: MSAT Lead (229794)

About Black Diamond Networks

Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond's delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
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