James Spinner Email & Phone Number

Saint Petersburg, FL, US

St Petersburg, Florida, United States

St Petersburg, Florida, United States

• 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.
• 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.
• 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

HPLC Method Development and Validation

Marlton, New Jersey, United States

• 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.
• 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.
• Maintained direct relationships with high profile customers including United States Pharmacopoeia.

• 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.