Jan Eilert, Csm, Cssgb Email & Phone Number

Dublin, OH, US

• Serve as senior consultant to big pharmaceutical companies with the following accomplishments:
• Authored submissions to meet FDA, ANVISA, NMPA, Latin America, ASEAN, and EU regulations.
• Developed and implemented CMC strategies for post-approval changes and health authority queries to global marketing applications.
• Managed complex projects and shifted priorities across multiple portfolios to meet milestones with a focus on quality and timely submissions.
• Managed cross functional collaboration with stakeholders to support multiple projects.

Deerfield, Illinois, US

• Manage multiple global programs utilizing matrix management approach and simultaneously serve as CMC lead. Oversee relationships with key raw material suppliers as liaison and build cross-functional relationships..
• Represent all CMC areas as spokesperson and decision maker for product development, ensuring information flow among all line functions, high quality science, technology, and deliverables, and compliance with global.
• Manage NDA/ANDA/PAS submissions and authored / prepared / reviewed / approved CMC CTD sections, interacting directly with FDA and South Korea MFDS during Prior Approval Inspections and responding urgently to regulatory.
• Utilize TrackWise system to manage multiple Change Control projects while also serving as CAPA or Change Control owner and building partnerships with quality, operations, CMO, CSO, R&D, regulatory, business, and legal.
• Manage discovery research projects in collaboration with universities, achieving publication of results in major scientific journal.
• Conduct exploratory cell culture and biochemistry research and diligently review publications related to BLA submission, increasing bioresearch knowledge and staying current with regulatory requirements.

Deerfield, Illinois, US

• Managed US Nutrition R&D team with responsibility for new parenteral nutrition product development, formulation development, and analytical method development / validation / transfer. Managed $2M budget to establish.
• Implemented creative approaches for team structure and resource needs, improving productivity and building strong teamwork culture.
• Created development opportunities for team members to take on leadership roles for studies or projects, including scientific, business acumen, and leadership training, and conducted performance reviews and provided.
• Led cross-functional teams for multiple programs concurrently, including Baxter Top Project, involving development, registration, and successful launch of entire portfolio of injectable nutrition products containing.

Deerfield, Illinois, US

• Led pre-mix injectable drug development and authored CMC CTD for NDA/ANDA submissions. Oversaw cross-functional CMC areas (formulation, analytical, stability, pre-clinical, process development) on core team of product.
• Authored CMC sections of ANDA and NDA submissions and provided technical support to address FDA queries, achieving high quality CMC deliverables and resulting in no CMC deficiencies in 6 ANDA/NDA pre-mixed drug.
• Led CMC cross-functional team for Baxter’s first premix drug development for Japanese market, achieving on-time approval and successful introduction of aseptic fill sterilization technique to Japan.

Deerfield, Illinois, US

• Developed, validated, and transferred analytical methods for raw material and finished products. Formulation development
• Supported drug product development projects, ensuring compliance with regulatory guidelines and pharmacopeia requirements (USP, JP, EP, BP) by developing, optimizing, and validating multiple analytical methods.

• Conducted bioanalytical chemistry experiments for research projects and assays, including ELISA and cell culture.
• Developed HPLC methods for separation of proteins and routinely conducted SDS-Page electrophoresis experiments, enabling successful completion of group research projects.

Silver Spring, MD, US

• Performed research investigating new extraction technology and developed analytical method for lipid analysis.
• Pioneered use of Supercritical Fluid Extraction methodology, achieving novel method for extraction of phospholipid from starch.
• Developed HPLC method for phospholipid analysis, mastering TLC, and silica open column chromatography.

Doctor Of Philosophy - Phd, Analytical Chemistry

Master Of Science - Ms, Analytical Chemistry

Bachelor Of Science - Bs, Chemistry