Nesher Pharmaceuticals (USA) LLC
  • 13-Sep-2017 to 12-Nov-2017 (CST)
  • R&D - Analytical
  • Bridgeton, MO, USA
  • Full Time

Competitive Benefits Package


Summary

Independently design, develop, validate and execute analytical methods and strategies to support Research and Development projects including raw materials, intermediates and finished dose products.  Write and execute method validation protocols and reports.  Demonstrate proficiency in a broad range of analytical techniques and instrumentation utilizing GMP compliance and current ICH guidelines.  Interface with Quality Control (QC) for Method Transfer activities, and provide support with respect to methodology problems and out of specification (OOS) investigations.  Test and monitor stability studies pertaining to new product development.                          

Essential Duties and Responsibilities

  • Develop and validate analytical methods in support of R&D product development.
  • Develop and validate analytical cleaning methods in support of Cleaning Validation/Verification.
  • Provide analytical technical support of R&D product development.
  • Perform isolation and identification of related compounds and impurities.
  • Perform relevant physical characterization of pharmaceutical products by development of discriminating dissolution methods.
  • Perform RLD evaluation, including reverse engineering principles.
  • Perform API characterization and raw material testing, including chemical and physical tests utilizing both Vendor methods and USP/NF monographs.
  • Troubleshoot, calibrate and maintain analytical instrumentation.
  • Write experimental protocols, summary reports, analytical methods, SOPs.
  • Maintain appropriate documentation (records and lab notebook) for all processes, observations and results as per SOPs and test methods.
  • Learn new techniques and solve complex analytical problems.
  • Perform training for team members. 
  • Provide expert review of technical issues and OOS investigations and develop appropriate action plans to deliver innovative solutions and definitive root cause analysis.
  • Provide continual benchmarking of methodology and technology platforms to make recommendations  for resource allocation, cost savings and increased efficiencies.
  • Interact effectively with multi cross-functional teams and work closely with other departments for preparation of regulatory filings.
  • Comply with lab SOPs, GLP, GMP, and company safety requirements.
  • Perform other related duties as assigned to meet departmental and company objectives.
  • Thorough understanding of and ability to apply QbD, SOP, GMP, GLP, ICH and compendia guidelines.
  • Familiar with current regulatory requirements for drug product manufacturing and ANDA submissions.
  • Ability to make literature searches and review raw material technical packets and correlate data to existing internal projects.
  • Proficiency in analytical instrumentation, including HPLC, GC, AA, FTIR, and ICP-MS.
  • Proficiency in analytical techniques, including physiochemical properties:  bulk tap density, hardness, solubility studies, particle size and morphology, and excipient compatibility studies.
  • Proficiency in raw material USP/NF monograph testing, including wet chemistry techniques.
  • Training skills to effectively develop and teach other team members.
  • Proven interaction skills to work effectively within multi cross-functional teams.
  • Ability to work independently.
  • Effective written and verbal communication skills.
  • 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 analytical method development and validation.

KNOWLEDGE/SKILLS/ABILITIES

  • Thorough understanding of and ability to apply QbD, SOP, GMP, GLP, ICH and compendia guidelines.
  • Familiar with current regulatory requirements for drug product manufacturing and ANDA submissions.
  • Ability to make literature searches and review raw material technical packets and correlate data to existing internal projects.
  • Proficiency in analytical instrumentation, including HPLC, GC, AA, FTIR, and ICP-MS.
  • Proficiency in analytical techniques, including physiochemical properties:  bulk tap density, hardness, solubility studies, particle size and morphology, and excipient compatibility studies.
  • Proficiency in raw material USP/NF monograph testing, including wet chemistry techniques.
  • Training skills to effectively develop and teach other team members.
  • Proven interaction skills to work effectively within multi cross-functional teams.
  • Ability to work independently.
  • Effective written and verbal communication skills.
  • 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 analytical method development and validation.

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 analytical method development and validation.

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
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