Nesher Pharmaceuticals (USA) LLC
  • 28-Aug-2017 to 27-Oct-2017 (CST)
  • R&D Formulation
  • Bridgeton, MO, USA
  • Full Time

Competitive Benefits Package


Summary

Provide formulation/process development /scale-up expertise 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.
  • Mentor and train junior scientists on formulation and process development work.
  • 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/SKILLS/ABILITIES

  • Thorough knowledge of Pharmaceutical Technology and Pharmacy, Chemistry and/or Chemical Engineering.
  • Thorough knowledge of pharmaceutical manufacturing equipment, especially with respect to equipment and processes used to manufacture immediate and extended-release oral solid dosage forms.
  • Broad knowledge of development and manufacturing procedures gained through education and experience.
  • Thorough knowledge of cGMPs and other regulatory requirements governing pharmaceutical manufacturing.
  • Proficient analytical skills.
  • Mentoring and training skills to effectively develop and teach other team members.
  • Proven interpersonal skills to interact effectively with a diverse group of individuals and teams.
  • Strong communication skills to effectively communicate in a clear, concise manner, whether in verbal, written or presentation form.
  • Must have the ability to take initiative and work independently where appropriate.
  • PC proficiency using Microsoft Office suite software.

 

EDUCATION/EXPERIENCE

  • Ph.D.  degree in pharmacy, chemistry, chemical engineering, or other related discipline with at least three years' pertinent, progressive experience in pharmaceutical or other highly regulated industry; or
  • Master's degree with at least five years' experience in pharmaceutical or other highly regulated industry;  or
  • Bachelor's degree with at least eight years' pertinent, progressive experience in pharmaceutical or other highly regulated industry.
  • Proven experience in Formulation, Process Development or Technical Services with direct experience in formulation & process development of immediate and extended-release oral solid dosage forms.
  • Experience with dry blending, wet granulation, compression and tablet film coating, Wurster coating, and powder/bead encapsulation required.
  • 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.
  1. 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.
Nesher Pharmaceuticals (USA) LLC
  • Apply Now

  • * Fields Are Required

    What is your full name?

    How can we contact you?

  • Sign Up For Job Alerts!

  • Share this Page
.
Logo Home Careers Products Locations Grow With Us