Sam Scholten Email & Phone Number

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 project-specific regulatory affairs strategy, CMC content expertise, product development advice and coordination oversight to internal and external clients. Ensure quality performance for key/managed personnel and projects. Identify and recognize out of scope activities in a contract in a timely manner and liaise with Contracts and Proposal Development (C&PD) to follow through on all aspects of contract modifications. Collaborate extensively with other departments within PPD, with other regulatory consultants and with regulatory authorities to support global projects. Maintain knowledge and understanding of PPD Standard Operating Procedures (SOPs), client SOPs/directives, and current regulatory guidelines. Ensure compliance with relevant organizational and RA SOPs and WPDs. Participate in project launch meetings, review meetings and project team meetings. Provide guidance, training, coaching and mentorship to personnel in RA.

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 oversight. Provide guidance on global regulatory guidelines and expectations as well as contribute to identifying submission-related risks and developing mitigation strategies with manufacturing leadership. Complete global strategy and authoring with respect to the chemistry, manufacturing and controls (CMC) sections of regulatory documentation.

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 quality matters pertaining to API production, Final Products produced by contract manufacturers, and Component specifications. Quality Assurance and Compliance point person to support business developments and vendor quality including remote or site audits for compliance against GMP, GLP, GCP, or ICH guidelines. Provide technical input for projects using the application of FMEA, risk mitigation, plant validations, DOE, and other experiments and investigations as appropriate. Oversee/lead projects using the application of continuous improvement tools as well as prepare quarterly reports to communicate quality assurance activities and metrics. Preparation and Review of both intermediate and finished product batch records for API, Final Product, and other GMP functions. The establishment, maintenance, and continual process improvement during Quality Systems Management.

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.