Analytical R&D Chemist

MAC Incorporated

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Analytical R&D Chemist Fenton, Missouri
Job Ref:
36427

Analytical Research and Development Chemist

 

Department:     Analytical R&D

 

FLSA Status:   Salaried

 

Function:         Responsible for developing analytical methods to study the physical or chemical properties of drug                           substances and formulations, with a view to determining the quality and stability of drug products. A                               strong familiarity with FDA and ICH regulations is required.

 

Primary Responsibilities and Essential Functions of the Position:

  • Analysis of R&D and its stability study sample.
  • Provide analytical support to Formulation Development.
  • Develop a new analytical methods for finish products (Assay, Related substances, Dissolution).
  • Qualify, validate methods and transfer methods to QC as needed.
  • Work with outside vendors to transfer established methods.
  • Understand US FDA requirements for generic drug product development and awareness of cGMP practices, ICH guidelines to manufacture quality products.
  • Work independently with minimum supervision and as a member of a multidisciplinary, international and culturally diverse research team.
  • Interact with colleagues with in department and with other departments to solve problems.
  • Sample organization as per internal procedure and per DEA requirements.

 

Skills and Abilities Required:

  • Experience with HPLC, Dissolution, GC, spectrometers, AAS etc.
  • Ability to develop assay, dissolution and impurity method to characterize critical quality attributes of potential development products.
  • Knowledge and awareness of cGLP, cGMP, and FDA submission.
  • Strong protocol, report writing skills
  • Experience developing analytical methods for pharmaceutical drug products.
  • Pharmaceutical analytical development/R&D experience.

 

Minimum Education and Experience Required:

  • BA, BS or MS in Pharmaceutical Sciences, Physical Chemistry, and Organic Chemistry, or related field with 1 year of laboratory experience.
  • Strong chromatography background preferred.

 

Physical Requirements:

  • While performing the duties of this job, the employee is regularly required to, stand, sit; use hands and fingers to operate a computer and telephone keyboard reach.  Light to moderate lifting.

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