Woodfield Pharmaceutical: Research and Development Scientist

Job Description:
The Research and Development Scientist develops and validates analytical methods per USP, ICH and FDA guidelines for new products. Perform product development and write method validation protocols and reports.

Directly Reports: Research and Development Manager

Duties and Responsibilities:

  • Perform analytical method development, optimization and perform validation according to in-house, USP, ICH or FDA guidelines
  • Supervise Research and Development Chemists and assist in completing group tasks
  • Perform peer review of analytical data
  • Perform product and process development for liquid and semi-solid dosage forms
  • Write protocols and reviews validation, pharmaceutical product and process development reports
  • Conduct stability tests on new product development for both laboratory batches or pilot/commercial lots
  • Write new analytical methods and optimizes/revises/revalidates existing methods, when necessary
  • Execute related duties as may be required by supervisor
  • Follow company policies and procedures
  • Observe and follow cGMPs and cGLPs

Job Requirements:

  • Knowledge of the principles and operation of various laboratory equipment (HPLC and GC systems, UV-Vis Spectrophotometer, Densitometer, pH-Meter, Viscometer, Polarimeter, Karl Fisher laboratory scales, etc.)
  • Knowledge in wet chemistry
  • Familiarity with USP/NF and AOAC procedures
  • Proficiency with computer and basic Microsoft Office tools (Word, Excel, Access) or any other required software that supports daily activities
  • Knowledge of the principles of cGMP and cGLP (current good manufacturing/laboratory practices) as outlines by the FDA
  • Knowledge about the FDA’s IND/NDA/ANDA submission process
  • Ability to be pro-active in order to anticipate potential needs that might affect the
  • Manufacturing Department activities
  • Knowledge of arithmetic, stoichiometry, statistics and other mathematical conversions of numbers
  • Ability to use deductive and inductive reasoning in problem-solving to come up with realistic answers
  • Ability to use strong verbal and written communication skills
  • Ability to anticipate potential problems so as to avoid and minimize out-of-specification investigations, along with strong problem solving and organization skills
  • Synthesize complex or diverse information
  • Pursue training and development opportunities
  • Strive to continuously build knowledge and skills
  • Write clearly and informatively
  • Present numerical data effectively; Able to read and interpret written information
  • Exhibit sound and accurate judgment. Demonstrates accuracy and thoroughness
  • Ability to work independently
  • Observe safety and security procedures
  • Report potentially unsafe conditions; Uses equipment and materials properly

Education:
Ph.D. degree or Masters degree in Analytical Chemistry, related degree or equivalent experience at least two years of pertinent and related industrial experience
Experience in wet chemistry analyses and USP/NF procedures
Trained and experienced with cGMP/cGLP
Experience in automated HPLC and GC systems and chromatographic software, FT-IR, UV-Vis Spectrophotometer

Physical Demands:
While performing the duties of this Job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel and to talk and hear

Work Environment:
While performing the duties of this job, the employee may be exposed to toxic or caustic chemicals and protective clothing or gear such as gloves and shoe covers may be required. The noise level in the work environment is usually moderate.

Eligibility Requirements:
Prospective employees are required to prove that they are legally entitled to work in the United States. WDPrx verifies work eligibility and the identity of new hires according to rules established by the Department of Homeland Security (DHS) and the Social Security Administration (SSA). Original documentation is required to verify your eligibility to work in the U.S.

How to Apply:
Send resume to careers@wdsrx.com

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