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. Establish project team procedures and lead governance meetings.• 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 regulatory and quality requirements, resulting in no CMC deficiencies and on-time approval.• 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 queries, enabling timely regulatory approval.• 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 teams, achieving collaboration, quality compliance, and on-time project delivery.• 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 GMP R&D laboratory with state-of-the-art analytical testing equipment, including UPLC, MS, HPLC, GC, CE, and ICP. Directed instrument qualifications (IQ/OQ/PQ) and computer software validation.• 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 feedback that generated staff success and productivity.• 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 amino acids and lipid emulsion in US. o Dealt directly with FDA during Prior Approval Inspection, including being involved with supplier qualification, eCTD NDA/ANDA/PAS preparation / submission, and regulatory response. o Developed products for pivotal clinical trials in US and ensured supplier and manufacturing facility compliance. o NDA submission was 1st eCTD NDA submission with clinical data for Baxter, resulting in granting of FDA Priority Review and FDA approval within 10 months.

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 development projects. Formulated, patented, and marketed various frozen, aseptic fill, terminally sterilized premixed aqueous injectable ANDA and NDA drug products (e.g., Cefepime, Brevibloc, Amiodarone). Conducted supplier approval audits in US and Japan.• 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 submissions while serving as decision-maker and CMC spokesperson.• 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