Manufacturing Supervisor
3 weeks ago
· Supervise the activities of production operators to ensure safe and compliant synthesis and/or cellular extraction of commercial oligonucleotides for Blood Screening Products.
· Responsible for responding to, addressing and providing guidance for production issues, safety incidences and/or personnel issues.
Responsible for all regulatory compliance (e.g., ISO 13485, FDA, IVDR) activities for assigned area and assures group compliance to cGMP and regulatory requirements through monitoring, trending and auditing.
Responsible for establishing and modifying the oligo synthesis (e.g., AKTA Oligopilot, HPLC systems) and/or production microbiology (i.e., BSL-2 and BSL-3 labs) production lines as a result of changing production needs and implementing process flow efficiencies/improvements.
What we are looking for in a Manufacturing Supervisor, Synthesis and Production Microbiology:
· Bachelor’s degree or Master’s degree in (Bio)chemistry, Chemical Engineering, Microbiology, Biology or related field.
· 6+ years of related GMP experience in a laboratory or commercial manufacturing setting with a Bachelor’s degree 4+ years of related GMP experience in a laboratory or commercial manufacturing setting with a Master’s degree 2+ years of supervisory or team leadership experience
· Must have in-depth knowledge of commercial-scale manufacturing.
· Must have a thorough understanding of GDP, cGMP and ISO 13485 regulations as they apply to commercial-scale manufacturing.
· Must have direct experience with oligo synthesis equipment (e.g., AKTA Oligopilot, AKTA Pilot/Beckman Purification systems, Dionex/Vanquish HPLC analytical systems, rotary evaporators).
Company DescriptionR&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.The cornerstone of our success: a knowledgeable and experienced recruiting team.
Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.Company DescriptionR&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.\r
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The cornerstone of our success: a knowledgeable and experienced recruiting team.\r
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Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.
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