Senior Scientist

Job Title: Senior Scientist

Location: US-NJ

Overview:

The Sr. Scientist leads formulation development of new pharmaceutical products through formulation optimization, product development and scale-up activities. Applying a solid understanding of theories/practices including those from other disciplines outside the primary area of expertise, independently plan, execute, and manage project(s). Provide assistance and interpretation of project results to team members and other business unit personnel. Ensure Standard Operating Procedures and protocols are maintained and applied.

Responsibilities:

Technical

• 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 benchtop 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 a 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, compile data and author technical and product development reports for ANDA submissions, and draft responses to FDA deficiency letters related to product development

• Maintain quality checks on the safety of the Lab, including biohazards, and ensure maintenance of the facilities according to Good Laboratory Practices.
• Understand and comply with all company safety, environmental, and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs, as well as, applicable federal, state, and local regulations.

Communications

• Effectively interact with other scientists, project managers and colleagues from numerous functions. Serve on multi-disciplinary project teams.
• Effectively communicate on results, delays etc., to the upper management and clients

Leadership

• Act as coach, mentor, and technical advisor to junior scientist
• May be sought out by other teams and individuals to offer technical advice.
• Effective planning and delegation of activities to meet critical timelines

Qualifications:

EDUCATION, EXPERIENCE and KNOWLEDGE REQUIRED:

• Master’s degree in Pharmaceutical Sciences, Formulation Chemistry or similar degree AND a minimum of 5-8 years of relevant experience in the pharmaceutical industry. Supervisory experience is preferred.
• PhD in Pharmaceutical Sciences, Formulation Chemistry or a similar degree AND a minimum of 3-5 years of relevant experience in the pharmaceutical industry, along with substantial experience and a proven track record of achievement (PhD will substitute for 3 years of experience).