Team Lead, Formulation R&D

Team Leader, Formulation R&D wanted by Renaissance Lakewood, LLC in Lakewood, NJ. Lead formulation team involved in formulation and process development and collaborate with MS&T team for technology transfer. Oversee pre-formulation, scale-up, and development of parenteral and nasal spray products. Ensure development of manufacturing process that can be scaled to commercial size, review technical protocols, reports for regulatory filings. Coach, mentor and serve as technical advisor to junior scientists. Lead the pre-formulation, optimization, and clinical readiness of multiple novel intranasal therapies. Translate biologics/peptides into stable, effective nasal spray formulations.

Requires Master's degree (or foreign equivalent) in Pharmaceutical Sciences, Formulation Chemistry, or closely related field, plus 5 years of experience in any related occupation.

• Must have 5 years of experience in pharmaceutical formulation development, process development, and technology transfer for scale-up activities.
• Must have 2 years of experience with product development regulatory requirements such as FDA and ICH guidelines.
• Must have 2 years of experience in Quality by Design (QbD) pharmaceutical development, including Design of Experiments (DoE) and risk assessment principles.
• Must have 2 years of experience in data analysis and interpretation supporting formulation and process development activities.
• Any required experience may have been gained concurrently.

Apply online at https://www.renpharm.com/careers/jobs/ or email resume to heather.colianni@ltslohmann.com