Manage a portfolio of over 35 New Chemical Entities (NCE) through the Analytical Research and Development (AR&D) and CMC phases of product development.• Represent Catalent in customer meetings as the Subject Matter Expert (SME) for all AR&D related activities and instrumentation, including HPLC, UPLC, HPLC-MS, GC, GC-MS, UV, ICP-MS, Dissolution (Apps I, II, III and IV), Disintegration, XRD, PSD and more.• Monitor progress and drive performance of development activities against project timelines and customer expectations. Interface with peers in other departments, senior management, customers and regulatory agencies.• Manage a team of 10 senior and junior analysts. Assure right-first-time execution of analytical activities. Identify and implement process improvements that will reduce cycle time to test and release products.

CMC responsibilities:• Laboratory manager responsible for coordinating product development activities including formulation development, method development, method validation and stability studies and quality control• Successful in the development and submission of over 26 Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA) for solid oral capsules, tablets, liquid solutions, suspensions and lipid based softgel formulations• Provide technical leadership for all CMC analytical activities on a daily basis to a group of 15 employees.• Responsible for instituting Quality by Design (QbD) principles into the drug product development process• Expanded laboratory expertise to include protein binding bioassays• Responsible for drafting Elemental Impurity, Residual Solvent and Nitrosamine Risk Assessments for allfinished products in order to ensure compliance with USP <232>, <467> and <1469>• Manage outsourced projects by fostering good working relationships with CRO and CDMO representatives, providing technical input and ensuring timelines are met while maintaining project budgeting constraints Regulatory experience:• Manage the preparation, review, and regulatory submission of ANDA documents to FDA for approval via the 505(j) and 505(b)(2) regulatory pathways, successfully bringing over 20 products to market• Regulatory lead responsible for drafting Module I, II and III of ANDA submissions, including the QualityOverall Summary (QOS) in the eCTD and QbR formats• Successfully petitioned FDA for Q1/Q2 Formulation Assessment and Competitive Generic Therapy (CGT) designation of ANDA submission via multiple controlled correspondence• Successfully petitioned FDA for a Pre-IND Meeting Request for potential new drug entity• Responsible for maintaining a working knowledge of currentyFDA regulations, USP, alternative compendia sources, and ICH guidelines effecting product development including Q2, Q3A, Q3B, Q3C, Q6A and Q8

HPLC Method Development and Validation

Symtera Analytics L.L.C. was a global distributor of high quality reference standards in the pharmaceutical, clinical, toxicology and life science industries. Symtera had a catalog of over 10,000 products and became the only reference standard provider with U.S. based inventory of DEA controlled substances.• Responsible for establishing and implementing all departmental operations within the company, including marketing, accounting, sales, logistics and human resource activities.• Managed the development of a product database with over 10,000 chemicals.• Responsible for all shipping, regulatory and logistical tasks necessary to maintain daily operations, serving customers in North America, the Caribbean, South America, Europe, Africa and Australia.• Negotiated, drafted and secured supply agreements with private manufacturers in Australia and India, and subdistributors in South America and Puerto Rico; secured a third party contract for warehousing of inventory, shipping/receiving services and controlled substance management.• Maintained direct relationships with high profile customers including United States Pharmacopoeia.• Successfully filed DEA import permits for controlled substances, schedule II – IV.• Obtained Level 2 USDA eAuth Account, used to import animal based products into the U.S.• Communicated with DEA, CBP and FDA regulatory authorities to successfully import and export high purity chemicals into the United States, including controlled substances.

Provided information and expertise across a wide variety of topics relating to the expansion of SunflowerPharmaceuticals into the US territory.• Helped to identify current marketed products with a high probability of commercial success in the US market.• Collaborated with marketing experts to provide insight and relevant data necessary to develop a comprehensive marketing strategy.• Performed regulatory/laboratory audit of a 100,000 sqft. state-of-the-art facility in South Florida capable of accommodating up to 400 employees for future operations.• Provided regulatory insight regarding the import and export of raw materials, animal-based raw materials and finished drug products into the US.