Stephen Andrews Email & Phone Number

Raleigh-Durham-Chapel Hill Area

Raleigh-Durham, North Carolina Area

Durham, North Carolina

-Responsible for the design and development of safe, efficient, and robust processes for the manufacturing of APIs- both NCEs and biopharmaceuticals- and drug products- solid and parenteral dosage forms. -Contributor to the CMC regulatory strategy for Drug Substance and Drug Product, including the selection and control of regulatory starting materials and potential genotoxic impurities. Interpret regulatory questions and drafting of initial responses from available data. Communicates and controls response timelines for CMC-Analytical. Authors analytical development and validation reports and analytical sections in IND, NDA , SNDA, MAA, and BLA filings.-Providing CMC project management for analytical activities of drug substance and drug product process development activities, as well as oversight of analytical activities conducted at CROs/CMOs for process development, process optimization, QbD/DOE, technology transfer, manufacturing, validation and regulatory filing activities for both drug substance and drug product. -Responsible for developing methods, quality control strategy and testing of small molecule and bio pharmaceutical drug candidates to support Phase I to commercial launch. -Responsible for operating in situations characterized by complexity, ambiguity and high levels of uncertainty. -Guide CROs/CMOs to design and perform method development and validation employing phase appropriate approaches at different stages of development (pre-clinical through Phase 3), for assay and dissolution methodologies, identification of impurity and degradation products, reference standard qualification and physical (solid-state) characterization; coordinate, monitor and evaluate project progression and timelines and quality of deliverables.

• Financial and operational management responsibilities for one or more functional areas• Responsible for technical operations of full scale development programs ranging from pre-IND to Ph IV, including pre-formulation work, process development, manufacturing cleaning verification, analytical method development and validation • Review and final approval of technical laboratory operations including method validation, method transfer, product characterization, stability testing, chromatographic troubleshooting, and maintaining compliance with cGMP procedures• Review of CMC regulatory documentation for regulatory submission • Responsibility for group’s deliverables and budget performance and planning. Prepare for and contribute to budget planning at the site. • Technical writing including analytical reports, clinical product specifications, test protocols, analytical test methods, and Standard Operating Procedures (SOPs).• Coordination of cross functional teams on development projects for completion of deliverables on time and within budget• Review and quality approval of aberrant and Out of Specification investigations, method deviations, and root cause analyses• Project management including oversight of project budgets, schedules, and performance requirements• Development and implementation of training strategies for team development• Team building, coaching, and motivation. Member of divisional recruitment team. Plan and lead employee development to achieve performance goals. Engage in organizational succession planning at the site. • Contributed to the development of the strategy for development of the Pulmonary and Nasal division capabilities• Supervising a technical scientific team of up to 12 chemists and overseeing their respective career growth