Leslie Moser Email & Phone Number

Philadelphia, Pa, Us

Exton, Pennsylvania, United States

Malvern, Pennsylvania, United States

In addition to the responsibilities under the previous Senior Manager position:• Mentors direct reports. • Collaborates with the Sr. Director to ensure new methods/technologies are incorporated into the testing paradigms.

Malvern, Pennsylvania, United States

• Coordinated/supervised the company’s internal and external activities related to regulated analytical/QC testing in support of cGMPs.• Managed PhaseBio’s stability program and related stability studies in compliance with internal SOPs and ICH guidelines.• Lead the QC sample management (coordination, shipments and aliquoting) and data review program, managed direct reports to ensure timely QC data disposition for product lot release.• Served as author and/or reviewer of CMC sections related to analytical methods, specifications, batch release and stability results in BLA/NDA and other regulatory submissions. • Evaluated/tracked/trended results and generated status updates and reports as needed for internal review.• Lead the writing of deviations, laboratory investigations, CAPAs, Change Controls, and Risk Assessments. Performed OOS investigations and maintained records according to GMP guidelines.• Ensured the completion of Analytical Development methods transfer to the QC lab and to contract test labs, assisted Analytical Development during method validation as needed.• Lead QC related technical troubleshooting including deviation handling and investigations.• Managed activities and reports to ensure work is completed within the targeted timelines.• Ensured compliance with cGMP and safety requirements, participated in audit preparation and carried out continuous quality improvements • Provided guidance and training to direct reports, motivated individuals to achieve results, ensured staff competencies. • Collaborated with the Sr. Director to ensure that Analytical / QC operations were appropriately staffed, training was completed, and the operation met both internal and external compliance (GMP) requirements.

Malvern, Pa

• Developed and optimized analytical protein chemistry methods for characterization and release of therapeutic fusion proteins.• Performed method qualification/validation studies according to established protocols.• Performed lot release and stability testing using a variety of biochemical, immunological, and molecular biology techniques such as ELISA, SDS-PAGE, Western blot, HPLC, etc. under GMP conditions.• Coordinated/oversaw the company’s external activities related to regulated analytical/QC testing in support of cGMPs.• Performed preclinical and/or clinical sample analysis under GLP conditions, including sample receipt, storage, testing, disposal, reporting, etc.• Performed pharmacokinetic assays via the Gyrolab and MSD platforms in support of protein therapeutic development.• Trained employees in GLP/GMP testing methods.• Contributed to the R&D pipeline through researching and presenting of potential candidates for new fusion proteins.• Drafted, reviewed, and implemented Standard Operating Procedures for laboratory operations/methods.• Authored research and technical reports to support regulatory filings.

West Point, Pa

Senior Scientist-Process Monitoring Group of Bioprocess Research & Development (BPR&D) (2005-2013)• Performed assays on an automated platform (TECAN), which included biochemical assays (colorimetric, dye-binding, and enzymatic) and immunoassays (sandwich ELISAs, binding-assays, residual assays). Ensured the highest quality of data in a timely manner to support process and formulation development, as well as release and/or stability testing of clinical supplies, for pre- and post-PCC vaccine programs. Metrics were accurately maintained to track assay performance, sample numbers, turnaround time, and rerun rate.• Utilized lab management and technical skills to serve as the technical lead for multiple assays. Experiments were proactively designed and carried out for assay optimization and troubleshooting to ensure successful assay performance. Data was regularly summarized and presented at project team meetings. Reagents were accurately managed. Assay procedures and technical reports were written to support the assays. Trained new analysts on the assays.• Performed second scientist reviews of notebooks in ELN with strong attention to detail in order to ensure the highest level of accuracy. This included the review of data in LIMS. Applied management skills to coordinate the priority and timing of all notebook reviews within the group. Trained other analysts on the SSR process.• Utilized leadership skills to drive the group’s compliance with cGMP standards. This ensured the highest quality of data and documentation. The laboratories were also regularly maintained for successful internal and external inspections. Represented the group on the GxP Subteam by providing timely communication between the group and the team in order to align to area wide cGMP interpretation and practices. • Promoted from Staff Biologist to Senior Scientist in 2012.

West Point, Pa

Staff Biologist-Cell Culture and Potency Assay Group (CCPAG) of Bioprocess Research & Development (BPR&D) (2002-2005)• Performed cell based assays (plaque assays and quantitative PCR analysis) to support release and stability testing as well as various characterization studies for the current vaccine programs. • Supported concordance studies to successfully compare a plaque and quantitative PCR analysis assay.• Wrote assay procedures and technical reports to support the assays.• Maintained the cell lines used in the assays, which included performing monthly mycoplasma screening of all CCPAG cell lines. • Utilized organizational and management skills to maintain a GMP laboratory.• Performed assay deviation investigations and drove efforts to improve the mycoplasma screening assay.• Promoted from Biologist to Staff Biologist in 2004.

Spring House, Pa

Employed by Kelly Scientific on the Analgesics Team in Drug Discovery • Performed a scintillation proximity assay (SPA) and a centrifugation binding assay to screen compounds for potential novel analgesic leads. • Further developed the binding assays by utilizing a cell based functional assay (FLIPR Calcium Assay) to optimize the type of cell line used. • Supported the assays by performing cell culture techniques and cell membrane preparation from tissues and human cell lines.• Utilized communication skills to regularly present work at Analgesics Team Meetings.

Spring House, Pa

Position was on the Analgesics Team in Drug Discovery - • Supported the development of cell based assays by constructing recombinant plasmids, analyzing via Western blot, and then performing transient and stable transfections of the various constructs into cells. Applied cell culture techniques.• Performed a cell based functional assay (FLIPR Calcium Assay) to drive the discovery of new analgesic compounds. • Utilized communication skills to regularly present work at Analgesics Team Meetings.

Collegeville, Pa

Position was on the Microbial Genetics Team in Drug Discovery • Worked on the construction of regulatable strains of Staphylococcus aureus to be used in the development of antibiotics.• Learned many molecular biology techniques such as cloning, gene expression, Western blot analysis, and bacterial strain characterization.