Sr. Scientist- Formulations

Job Title: Senior Scientist, Formulation Development

Location: Lakewood, NJ

Status: Onsite Monday- Friday

Salary: $140,000

Please note, experience in liquid, gel or combination injectables and formulation development is required. Experience in nasal spray development highly preferred.

Overview:

This position leads formulation development of new pharmaceutical products through formulation optimization, product development and scale up activities. This will be a hands-on role in the lab and will be mentoring other junior Scientists.

Responsibilities:

• Lead and perform formulation and pre-formulation activities in the development and scale-up of pharmaceutical products including parenterals (solutions and suspensions), and ophthalmic (solutions, suspensions and ointments), and nasal products from bench top to pilot-scale to commercial production. This may entail technology transfer from other plants as well.
• Applying effective search strategies conduct scientific literature searches and provide critical evaluation of the literature.
• Identify and lead efforts to improve processes/systems while meeting all regulatory and quality requirements.
• Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
• Prepare data summary presentations, compiling data and authoring technical and product development reports for ANDA submissions, and draft responses to FDA deficiency letters related to product development

Qualifications:

• Bachelor’s Degree with 5-7 years, or Master’s degree in Pharmaceutical Sciences, Chemistry, or similar degree and a minimum of 3-5 years of relevant experience in the pharmaceutical industry is required. Supervisory experience is preferred.

• PhD with a minimum of 1-2 years of experience is preferred, along with substantial experience and a proven record of achievement (PhD will substitute for 3 years of experience).