Job Title: Formulation Scientist
Department/Group: Product Development
Location: Somerset, NJ
Position Type: Contract

Role Summary
Perform formulation development, generate formula, and scale up processes in support of ANDA or NDA submission batches, in a regulated development and manufacturing environment.

Essential Duties and Responsibilities:

• Review Literature and gather patents and published articles on the selected projects.
• Analyze and interpret results in written and oral format in consultation with Product Development Management.
• Determine the best possible strategy for formulating assigned projects and meet regulatory criteria.
• Perform pre-formulation studies and physical-chemical characterization of materials and dosage forms.
• Perform formulation experiments to develop ANDA or NDA submission batches.
• Responsible for CMC documentation, project documentation and for preparing necessary technical reports.
• Perform all the processing steps such as weighing, blending, milling, compression etc.
• Directs the work and schedules of technicians and provides technical assistance to associates and other formulation scientists.
• Maintain accurate lab notebooks and complete all related development reports, in compliance with departmental needs and SOPs.
• Technical responsibility for interpreting, organizing, executing and coordinating assignments and assigned development projects.
• Maintains liaison with individuals and units within or outside of the organization as directed by Product Development Management.
• Plans, organizes and supervises the assigned work staff of associates and
• technicians.
• Responsible for project management of assigned product development projects.

• Responsible for the production of clinical supplies
• Ensure equipment and materials are available in a timely fashion for submission batches and to coordinate with the manufacturing department as needed.
• Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and safety practices.Education & Experience:

• Master’s degree (or higher) in a pharmaceutical science field preferred.
• Minimum 4 years of experience in pharmaceutical drug product development, preferably in generic pharmaceuticals.
• Technical expertise necessary to design pharmaceutical products and manufacturing processes.
• Proven ability to supervise technical and operational personnel.

Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in a laboratory environment.

Job Type: Contract

Salary: $25.00 - $50.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to Commute:

• Somerset, NJ 08873 (Required)

Ability to Relocate:

• Somerset, NJ 08873: Relocate before starting work (Required)

Work Location: In person