Yan Alsmeyer Email & Phone Number

California, United States

Waltham, Ma, Us

Redwood City, California, Us

Foster City, Ca, Us

Established a commercial analytical operations team of 50 members in-house and 100+ dedicated FTEs at contract sites, focusing on quality control and stability testing in support of globally manufactured commercial bulk drug substances (APIs) and drug products (DPs). Negotiated supplier quality agreements to ensure high-quality standards and business needs achievement on time and within budget. Directed life cycle management of commercial test methods including method optimization, transfer, and additional validation to establish new manufacturing or testing sites for APIs and DPs.* Ensured timely delivery of API, a new chemical entity (NCE) and DP to meet market demands of a new oncology product and supported on-going clinical studies. Critically reviewed and secured successful global regulatory approvals.* Drove a refined risk-based selection, qualification, and requalification process for contract partners, and dramatically enhanced the process of independent API test result verification that significantly reduced incoming release testing of APIs at DP sites.* Led a cross-functional operational excellence corporate team, and designed/implemented an end-to-end automated technology solution to provide partners with Gilead product/process control information while tracking relevant partner implementation. * Critically reviewed numerous protocols and reports of various special studies in support of API and DP quality evaluation.* Created a tailored, statistically-based stability trending program to consolidate and effectively reduce stability studies for established commercial APIs and DPs by 50%.* Served as the focal point for commercial analytical operations and led the identification of deviations, design of CAPAs, and management of change controls for commercial products to ensure quality investigations.

Toronto, Ontario, Ca

Directed a R&D staff of 80+ and report directly to the EVP in Product Development. Served as a key member of the corporate leadership team, responsible for full characterization of drug substances, reference listing drugs, and drug product development. Drug product dosage forms supported include capsules, tablets, and softgel capsule products of IR and various controlled release characteristics using technologies including hot melt, drug layering, tablet-in-tablet, tablet-in-capsule, controlled release coating, and hydrogel based matrix. This led to a significant number QbD based ANDA filings globally and new product launches annually. Provided leadership to establish quality target product profile (QTPP), evaluate API sourcing options, assess legal landscape, and perform preformulation and deformulation. Oversaw the development of physical, performance and analytical methods, method validation and transfer strategies. Set, justify, and defend specifications.Directed product development through full performance characterization of RLDs and Apotex development formulations using various dissolution conditions and biorelevant in vitro release profile target obtained using available in vivo PK data. Led RLD deformulation including API physical properties in the drug product matrix to guide the selection and control of API to be used in drug development. Provided critical guidance in IVIVC/IVIVR based justification for biowaiver or widening of dissolution specifications using WinNonlin. Led bilateral corporate partnership between Apotex and a major instrument companies. Spear-headed corporate laboratory automation technology. Led the corporate effort in establishing ICP-MS as an in-house capability and facilitate with API suppliers globally, and Apotex affiliates internally to devise and implement compliance strategies to USP, EP, and ICH Q3D requirements in finished products.

Maple Grove, Mn, Us

Established a new corporate department with internal competence and external capacity. Identified a team of consultants and contract research organizations to support Upsher-Smith early phase drug development to design, prepare lead and backup compounds, and scale-up selected compounds. Led the development of compound screening cascades, and directed compound screening to meet company key NDA program milestones. Represented early phase drug development in corporate due diligence efforts to evaluate in-license opportunities. Served on a corporate steering to incorporate the Stage Gate process in new product development.Led the corporate specification committee, review and approved specifications for all new and marketed products.

Maple Grove, Mn, Us

Responsible for method development and validation, and stability programs in support of new product development of solid dose forms, semisolids, parental and nasal products. Led the department strategic planning and addressed gaps in capacities and capabilities,successfully recruited for and filled multiple strategic positions to support the corporate R&D strategy of becoming a semi-virtual NDA company. Represented the corporate in interactions with FDA on general GMP audits, PAIs, pre-IND, EOF-2, and pre-NDA face-to-face and telephone conferences and due diligence reviews of selecting potential new product and technology in-licensing opportunities. Led drug substance supplier selection process and performed over 60 supplier audit worldwide per ICH Q7. Set corporate strategies on extractable and leachable studies for the evaluation of container closure systems, in vitro release rate method development and validation using Franz-cell apparatus for semi-solid products, and CACO-2 studies for permeability to successfully secure BCS-based biowaiver for ANDAs.Established in-house preformulation capabilities. Implemented drug development phase appropriate method validation and refined document content templates to streamline and standardize method validation to support CTD regulatory submissions. Institutionalized QbD philosophies in product development, and led the development of technical guidelines for HPLC, Dissolution and GC method development and optimization. Established a corporate Metrology group. Provided the structure and discipline in the Metrology group for the centralization of instrument calibration and maintenance. Orchestrated and executed with precision a corporate physical relocation plan.

Maple Grove, Mn, Us

New York, New York, Us

Kingsport, Tennessee, Us

Ph.D., Chemistry

B.S., Organic Chemistry

Ms, Organic Chemistry