• Developed a streamlined product development process incorporating QbD principles based on ICH Q8, Q9, Q10, adaptable to the needs of fast-paced generic and product enhancement projects. As part of this process, facilitated technical risk assessments on five different projects (including parenterals, oral liquids, medical device).• Delivered a variety of in-house training sessions on the CTD P2 section, and concepts of QbD.• Identified new product enhancement opportunities for established products and emerging markets business units leading to initiation of six projects (6-month depot injection, multi-dose IV, IV lyophile with improved stability, topical semisolid, liposomal IV, seven-day transdermal patch).• Designed lab feasibility studies to demonstrate technical viability of several new product concepts for established products and emerging markets business units.• Provided strategic and technical consultation on product development and regulatory submissions for numerous generic and 505(b)(2) parenteral projects at internal and external development sites, including critical and comprehensive reviews of regulatory submissions.• Performed technical due diligence for seven product licensing and portfolio acquisition opportunities (parenteral and topical dosage forms).• Led a multi-site project team to develop product enhancements of a high-volume parenteral product (improved stability to allow room temperature storage and multi-dose option) to target launch at LOE.

• Authored (P1, P2, P3 sections) and served as critical reviewer of all other Module 3 sections of the Exubera CTD, numerous query responses, and participated in various agency meetings as technical expert on both device and drug product. • Provided extensive technical consulting (product development approaches and strategy as well as critical dossier reviews) on multiple parenteral projects in Established Products Business Unit.• Created and led the Topical Product Development group (4 direct reports), including creation of a topical/ transdermal product development lab.• Facilitated technical risk assessments on product and process design for several development projects.• Established a broad program for nurturing scientific excellence in the department.

• Led two joint R&D teams in Nektar partnership on Exubera® (inhaled insulin DPI): drug product and inhaler performance and robustness characterization.• Developed an IV/IVc for Exubera, enabling identification of the clinically relevant aerosol quality attributes (critical and non-critical), allowing a unique and commercially manageable approach to aerosol specifications.• Designed comprehensive performance characterization programs for the Exubera inhaler and drug product, including strategy definition, experimental designs, and data analysis/interpretation for the more complex and inter-related performance characterization studies. Developed scale-up strategy for spray drying and established Design Space for several CQA’s for both drug product and inhaler.• Managed the Liquids Technology Transfer group (4 senior scientists)• Pharmaceutical Expert and Expert Report author for three European Marketing Authorisation submissions (Zoloft Oral Concentrate, Geodon IM, Advocin 180 Injection).• Formulator and Pharmaceutical Expert leading to commercialization of several liquid and parenteral products: Dectomax Pour-On, Zoloft Oral Concentrate, Geodon IM, Advocin Injection, Trovan IV • Supervised 2-4 lab scientists