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Sam Scholten is listed as Senior Manager Regulatory Affairs- CMC at PPD at PPD, a company with 20768 employees, based in Omaha, Nebraska, United States. AeroLeads shows a matched LinkedIn profile for Sam Scholten.
Sam Scholten previously worked as Senior Manager Regulatory Affairs- CMC at Ppd and Consultant, Scientific Consulting - CMC at Cardinal Health. Sam Scholten holds Bachelor Of Science (Bs), Biochemistry And Molecular Biology from Northwest Missouri State University.
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Experienced CMC Regulatory Affairs professional with a strong background in the pharmaceutical industry spanning more than two decades. Demonstrated expertise in coordinating global regulatory compliance, leading CMC-related submission document development, and providing strategic guidance to cross-functional teams. Skilled in regulatory strategy, submission authoring, and project management. Broad background including early development through global life cycle management of multiple small molecule, monoclonal antibody, vaccine, and varied large molecule products. Adept at collaborating with internal and external stakeholders to ensure regulatory approvals and adherence to industry standards. Strong leadership, communication, and mentoring abilities, coupled with a commitment to excellence in pharmaceutical CMC regulatory affairs.
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Greater Omaha Area
Responsible for the planning, preparation, authoring, and review of submissions with respect to the CMC sections of regulatory documentation for multiple pharmaceutical products including small molecules, combination products, proteins, and advanced therapies (ATMPs). Act as subject matter expert in providing regulatory strategy advice as well as.
Overland Park, KS
Responsible for the planning, preparation, authoring, and review of submissions with respect to the CMC sections of regulatory documentation for multiple pharmaceutical products including small molecules, combination products, and proteins. Act as subject matter expert in providing CMC content expertise, product development advice and coordination.
Responsible for primary oversight of Quality Assurance, Quality Control, Microbiology, and Document administration. Quality Control testing includes in-process, release, raw material, and stability testing. Completed managerial oversight of both in house and contract testing as well as approval of all results.Provide compliance expertise and direction for.
Supervised 5-10 people doing PCR testing for HIV, HCV, and West Nile Virus.
Analytical laboratory work including; gel electrophoresis, capillary electrophoresis, western blot, method development, method validation, osmolarity, bioassay, cell culture, and general laboratory test procedures.
Other employees you can reach at ppdi.com. View company contacts for 20768 employees →
Jamilah Wazir
Colleague at Ppd
Jakarta, Jakarta, Indonesia, Indonesia
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MV
Marina Van Staden
Colleague at Ppd
City Of Cape Town, Western Cape, South Africa, South Africa
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NR
Nur R.
Colleague at Ppd
Singapore, Singapore
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DJ
Danielle James
Colleague at Ppd
Houston, Texas, United States, United States
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TM
Tara Mannherz
Colleague at Ppd
Holly Springs, North Carolina, United States, United States
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AV
Akshaya Vijay
Colleague at Ppd
Coimbatore, Tamil Nadu, India, India
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LC
Leila Cukic
Colleague at Ppd
France, France
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JS
Judit Szigeti
Colleague at Ppd
Budapest, Budapest, Hungary, Hungary
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JL
Jannet Legua
Colleague at Ppd
Peru, Peru
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KM
Katlego Mapetla
Colleague at Ppd
Pretoria, Gauteng, South Africa, South Africa
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Quick answers generated from the profile data available on this page.
Sam Scholten works for PPD.
Sam Scholten is listed as Senior Manager Regulatory Affairs- CMC at PPD at PPD.
Sam Scholten is based in Omaha, Nebraska, United States while working with PPD.
Sam Scholten has worked for Ppd, Cardinal Health, Exoxemis, Inc, Community Blood Center, and Quintiles.
Sam Scholten's colleagues at PPD include Jamilah Wazir, Marina Van Staden, Nur R., Danielle James, and Tara Mannherz.
You can use AeroLeads to view verified contact signals for Sam Scholten at PPD, including work email, phone, and LinkedIn data when available.
Sam Scholten holds Bachelor Of Science (Bs), Biochemistry And Molecular Biology from Northwest Missouri State University.
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