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Analytical Research and Development Chemist

Alkem Laboratories Ltd.
Fenton, MO
Closing date
Jun 24, 2022

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Science, Chemistry, General Chemistry
Organization Type
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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. Provide full Analytical support to achieve Alkem's goal. A strong familiarity with FDA and ICH regulations is required.

Primary Responsibilities and Essential Functions of the Position:
  • Develop new analytical methods for finish products of various formulations (Assay, Related substances, Dissolution, residual solvents, and others if any).
  • Qualify, validate, and transfer analytical methods for API, raw materials, and finish products in QC, with appropriate documentation of these activities.
  • Provide analytical support to Formulation Development on various formulations.
  • Analysis of various R&D samples at initial and during stability.
  • Work with outside vendors to transfer established methods.
  • Understand US FDA requirements for generic drug product development, create API, Raw material, and finish product specifications.
  • Aware 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 and coordinate with different departments for product filing and to solve problems.
  • Maintain control substance inventory as needed basis.
  • Procurements of the chemicals, reagents, and standards as needed.
  • Provide support to close OOS, investigations as needed.

Skills and Abilities Required:
  • Ability to develop in vitro assays to characterize critical quality attributes of potential development products
  • Experience with HPLC, GC, spectrometers, AAS, Dissolution apparatus, wet chemistry techniques etc.
  • Knowledge and awareness of cGLP, cGMP, and FDA submission.
  • Strong verbal and 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, Organic Chemistry, analytical chemistry, or related field with 1 year of laboratory experience.
  • Strong chromatography and wet chemistry background preferred.
  • Experience in solid oral extended-release formulations is preferred.
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