Nesher Pharmaceuticals (USA) LLC
  • 31-Aug-2017 to 30-Oct-2017 (CST)
  • Process Development
  • Bridgeton, MO, USA
  • Full Time

Competitive Benefits Package


SUMMARY

Provide Process Development leadership and expertise for the development of immediate release, extended-release, oral solid, and liquid dosage forms at various development stages, up to Validation. Lead and perform scale-up activities post ANDA submission or as part of Tech Transfer activities. Provide support to product lifecycle development and ongoing efforts for process improvements. Write experimental protocols, and 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 Research & 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

  • Support Quality by Design (QbD) efforts for the reintroduction of previously approved and manufactured products and new products. 
  • Design and execute process development studies to develop a thorough understanding of operating and performance parameters.
  • Plan, carry out and supervise process trials for QbD, new product development, and technology transfer activities.
  • Lead, participate in, and/or report to a cross-functional development team to advance production activities.
  • Lead technology transfer team and activities post ANDA submission, all the way to Validation.
  • Lead the efforts to introduce new technologies to operations.
  • Provide input and assistance to Operations and Validation in the scale-up, validation and launch for the reintroduction of previously approved and manufactured products, as well as new products.
  • Assist in equipment set-up and manufacture of pilot/manufacturing scale batches.
  • Write experimental protocols, protocol summary reports, development Master Batch Records and development Master Packaging Records.
  • Provide input and support to Formulations Group in prototype, scale-up and exhibit batch manufacture.
  • 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.
  • Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
  • 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.
  • Ability to lead effectively and concurrently on multiple projects in a goal-oriented, timeline-driven, and dynamic work environment while ensuring quality and accuracy.
  • Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the Company.
  • Proven technical writing proficiency to write and review technical documentation (batch records, SOPs, protocols and reports, IQ/OQ/PQ testing, and validation testing).
  • Demonstrated and applied knowledge of pharmaceutical manufacturing equipment, especially with respect to equipment and processes used to manufacture immediate release, extended-release oral solid dosage forms and liquid 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.
  • Demonstrated verbal and written communication and presentation skills on technical and non-technical topics.
  • Strong analysis skills.
  • PC proficiency using Microsoft Office.

 

Education/Experience

  • Bachelor's degree in pharmacy, chemistry or chemical engineering with at least eight years' pertinent and progressive experience or Master's degree with minimum of four years' experience.
  • Experience in Formulations, Process Development or Technical Services, with direct experience in formulation and process development of immediate release, extended-release oral solid and liquid dosage forms. Experience with dry blending, wet granulation, fluid bed drying/coating, compression, tablet film coating, and powder encapsulation required. 

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, climb, balance, stoop or crouch, kneel, reach, push, pull, 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 frequentlyand/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck 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. Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.
  1. Individual is in a proximity to moving mechanical parts, electrical current and  exposure to chemicals.
  2. Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.
  3. 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
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