Position Summary:

The Formulation Scientist is primarily responsible for the formulation product development and submission of regulatory documents for oral solid dosage and other pharmaceutical dosage form.

Responsibilities: Responsibilities include, but are not limited to:

• Design formulations for solid dosage forms in nutraceutical, over the counter and prescription drugs.
• Manage multiple development projects and develop formulations in a timely manner.
• Write protocols, master manufacturing records, and product development reports.
• Provide support to production in process improvement and troubleshooting.
• Stays current with recent advances and trends in the drug delivery technology and regulatory policies.
• Other responsibilities as assigned by Senior Management.

Education and Experience:

• MS or Ph.D. degree in Pharmaceutical Sciences is required.
• Experience in Pharmaceutical R&D formulation, preferably in generic industry.
• Experience with formulation equipment such as blender, fluid bed dryer, high shear granulator, tablet press and other such equipment.
• Desire to work in a fast-paced manufacturing facility with unlimited career growth potential.

Skills and Abilities:

• Knowledge of cGMPs related to US FDA and EU EMEA manufacturing environments.
• Knowledge of Quality System requirements.
• Knowledge of ICH, USP, and EP requirements.
• Excellent oral and written communications skills, working knowledge of MS Office.
• Ability to prioritize and multitask.
• Motivated, detailed, organized.

Working Conditions:

• Work/Travel schedule must be adhered to and/or changed as needed to meet business requirements. Standing, bending, kneeling, picking up boxes are part of role.
• Regular, ongoing travel throughout geographic areas on a continual basis as normal scope of role.
• Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion.
• While performing the duties of this job, the employee is regularly required to sit, stand or walk for long periods. The employee may lift and/or move up to 50 lbs. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus.

Supervisory Responsibilities:

• None

Personal Protective Equipment or Attire Required for Position:

• As needed

Salary Range:

$70,000 - $90,000 per year