Nesher Pharmaceuticals (USA) LLC
  • 25-Jun-2018 to 24-Aug-2018 (CST)
  • R&D - Analytical
  • St. Louis, MO, USA
  • Full Time

Competitive Benefits Package


Summary

Perform basic routine analysis on limited equipment, complying with all applicable SOPs, GLP, GMP, housekeeping and safety regulations. Perform basic wet chemistry techniques and sample preparation for raw materials, intermediates, finished dose products and stability. With supervision, operate equipment as well as perform basic calibration and preventive maintenance for equipment. Support formulation development activities using QbD approach. Participate in some method validation activities. Provide team leaders and supervisors with project status and testing updates.

Essential Duties and Responsibilities

Perform basic routine analysis on limited equipment. Perform basic wet chemistry techniques and sample preparation for raw materials, intermediates, finished dose products and stability. Participate in some method validations. Provide team leaders and supervisors with project status and testing updates.

· Comply with all applicable SOPs, GLP, GMP, housekeeping and safety regulations.

· Follow good laboratory practices (GLP) and SOPs maintaining thorough, complete, accurate and timely record of laboratory data.

· Complete chemical, physical or instrumental assay accurately on any pharmaceutical product, in-process material, raw material, cleaning swab or stability as directed.

· Participate in some method validation activities to support R&D product development.

· Provide necessary analytical technical support of R&D product development.

· Participate in instrument calibration and preventive maintenance as directed.

· Document critical observations pertaining to analytical testing in support of product development.

· Participate in API and raw material testing, including chemical and physical tests utilizing both Vendor methods and USP/NF monographs.

· Interact effectively with team members.

· Participate in OOS investigations and help identify root cause.

· Learn new skills/techniques in order to progress to the next level.

· Participate in continuous improvement of methodology and technology and finding ways to save cost and increase efficiency.

· Perform other related duties as assigned to meet departmental and company objectives.

KNOWLEDGE/SKILLS/ABILITIES

Working knowledge of analytical instrumentation commonly used in pharmaceutical testing such as HPLC, UV-VIS, Dissolution.Knowledge of wet chemistry techniques and equipment.Thorough understanding of current SOPs, cGMP, GLP and ICH guidelines.Ability to follow direction and work under supervision.Understanding of QbD in drug product development.Familiar with regulatory agencies such as FDA, USP and DEA.Effective written and verbal communication skills.

EDUCATION/EXPERIENCE

Bachelor's degree in chemistry or a related field in science.

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:

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

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.

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:

Individual is in a proximity to moving mechanical parts and exposure to chemicals.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?

    I agree to AAIM's Applicant Information Use Policy.*
  • Sign Up For Job Alerts!

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