Formulation Scientist

Summary

Provide formulation/process development/scale-up support for the development of immediate release and extended-release oral solid dosage forms. Perform scale-up for oral solid dosage forms. Provide support to product lifecycle development and ongoing efforts for process improvements. Write experimental protocols, assist in equipment set-up, and the manufacture of pilot /manufacturing scale batches. Execute experimental protocols, assist in sample collection and submission for testing, and perform physical tests as required. Write and issue protocol summary reports and assist in Technology Transfer of products from Development to Operations. Provide support to Quality Assurance and Operations with respect to major process/product problems. Initiate and monitor stability studies pertaining to new product development. 

Essential Duties and Responsibilities

• Design and execute formulation and process development studies for assigned projects.
• Support Quality by Design (QbD) efforts for the reintroduction of previously approved and manufactured products and new products.  Write experimental protocols and protocol summary reports.
• Assist in the equipment set-up and manufacture of pilot/manufacturing scale batches
• Write development Master Batch Records and development Master Packaging Records.
• Provide input and assistance to Operations and Quality Assurance –Validation in the scale-up, validation and launch for the reintroduction of previously approved and manufactured products, and new products.
• Provide input and assistance to Quality Assurance and Operations for major process/product problems.  Carry out experimental studies to support vendor qualification efforts.
• Recommend and justify the purchase of new equipment for Research & Development. 
• Assist Engineering in the Installation and Qualification of Research & Development Equipment.
• Establish/maintain outside contacts for information exchange regarding manufacturing technologies, theories and developments.
• Perform other related duties as assigned to meet departmental and Company objectives.
• Knowledge of Pharmaceutical Technology and Pharmacy, Chemistry and/or Chemical Engineering.
• Knowledge of pharmaceutical manufacturing equipment, especially with respect to equipment and processes used to manufacture immediate and extended-release oral solid dosage forms.
• Knowledge of development and manufacturing procedures.
• Knowledge of cGMPs and other regulatory requirements governing pharmaceutical manufacturing.
• Effective communication and analysis skills.
• PC proficiency using Microsoft Office suite software.

KNOWLEDGE/SKILLS/ABILITIES 

• Knowledge of Pharmaceutical Technology and Pharmacy, Chemistry and/or Chemical Engineering.
• Knowledge of pharmaceutical manufacturing equipment, especially with respect to equipment and processes used to manufacture immediate and extended-release oral solid dosage forms.
• Knowledge of development and manufacturing procedures.
• Knowledge of cGMPs and other regulatory requirements governing pharmaceutical manufacturing.
• Effective communication and analysis skills.
• PC proficiency using Microsoft Office suite software.

EDUCATION/EXPERIENCE

• Ph.D.  degree in pharmacy, chemistry, chemical engineering, or other related discipline; or
• Master's degree with at least three years' pertinent, progressive experience in pharmaceutical or other highly regulated industry;  or
• Bachelor's degree with at least five years' pertinent, progressive experience in pharmaceutical or other highly regulated industry.
• Experience in Formulation, Process Development or Technical Services with direct experience in formulation & process development of immediate and extended-release oral solid dosage forms preferred.
• Experience with dry blending, wet granulation, compression and tablet film coating, Wurster coating, and powder/bead encapsulation.
• Experience in the development of liquid dosage forms is a plus.

Work environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

1. Stand, walk, sit, balance, stoop or crouch, kneel, reach, push, grasp, feel, talk, and hear.

1. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.

3. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects. 

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

1. Individual is in a proximity to moving mechanical parts and exposure to chemicals.
2. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face  supplied air respirators.

Current Openings for Formulation Scientist Jobs at Nesher Pharmaceuticals (USA) LLC