Lead the external analytical process development team covering both small molecule and large molecule programs. Work includes method development, method qualification, method validation, release testing, stability studies, one off analytical testing support, product characterization and requalification of standard materials. Work covers FIH through PPQ batches.

Leads team that oversees external analytical testing for synthetic and biologic programs from pre-pivotal through commercial stages.

Managing Contract Labs and Drug Product Contract Manufacturers for small and large molecule pharmaceutical projects globally. Contract laboratory management includes overseeing method development, method validation, method transfers, protocol generation, stability testing, release testing, investigations, deviations, product characterization, tracking metrics, setting up budgets and approving invoices.Contract manufacturer management includes overseeing drug product manufacture of FIH clinical study material for small and large molecule programs. This includes coordinating efforts to have all supplies available at manufacturing site (DS, filters, tubing, vials, seals, stoppers, excipients, tank design/builds, etc), qualification of lines and processes at site (media fills, machinability runs, capping DOE studies), batch record generation and review, overseeing investigations, creation of shipping lanes, tracking of metrics, setting up budgets and approving invoices.Also have over seen contract clinical packaging which included navigating through the change in EU quality person required reviews, reviewing labeling and packaging batch records, creating shipping lanes and help establish receiving process at clinical sites as well as maintaining inventory records.

Small molecule method development, method validation and stability testing all under cGMP. Lead the analytical testing of comparator projects for clinical trials.Helped bring in, test and qualify automated equipment into the lab to increase efficiency.Worked on Empower integration team and helped with LIMs stability management.

Primary responsibilities include investigating failures in laboratory operations, investigating failures in validations, training scientists, running house standard qualifications, performing PF evaluations, investigating anomalous results, keeping up-to-date with regulatory requirements and SOPs, following current GMP/GLP guidelines, calibrating/maintaining instruments, reviewing notebooks, first aid responder, and hazmat responder.Testing performed included moisture, identity, related substances, purity, total impurities, potentiometric titrations, colorimetric titrations, and assay.Technical skills learned include extensive work with HPLC, Karl Fischer and general wet chemistry. Created Right First Time initiative in LTS group. This project is being used as a guideline for what must be in the notebook write-ups as well as a metric for team supervisors.Work as Empower project qualifier which entailed setting up projects with in Empower to be run by analysts in the lab. Began training to be an administrator for Empower and LIMS.