Analytical Development Scientist I – Temporary (R-ADS)

Analytical Development Scientist I – Temporary (R-ADS)

Location: Rochester, Michigan

Position Summary:

In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.

Performs HPLC method development and usage as needed to carry out ad-mix studies in support of MCP NDAs. Familiar with LC, plus all the other lab skills. Performs all activities following company policies.

  • Performs analytical method development per FDA, ICH, USP/NF and other applicable pharmacopoeias and/or guidelines.

  • Applies fundamental knowledge of Analytical Chemistry and advanced technologies in analysis, interpretation and understanding of the test results, for both qualitative and quantitative analyses.

  • Participates in the planning, writing and execution of protocols needed for ad-mix studies in support of MCP NDAs

  • Writes technical reports presenting the results of the ad-mix studies.

  • Writes, edits and revises analytical procedures and SOPs.

  • Performs routine maintenance, calibration, and performance verification on applicable instruments.

  • Performs routine and non-routine testing, as required following company policies and participates in overall compliance for the Product Development Laboratory.

  • Assists in training of laboratory staff.

  • The employee may need to be trained in handling controlled substances.

  • Establishes and maintains effective cross functional relationships.

Minimum Requirements:

Education / Qualifications / Certifications: Bachelor’s Degree in Chemistry or related science field with at least 4 years of analytical chemical laboratory experience. Pharmaceutical laboratory experience in analytical methods development and validation area will be extremely helpful. Equivalent combination of education and experience or training is acceptable.

If you possess the required background and are interested in being a member of this growing company, submit your resume and a cover letter and Apply Online

About MCP Pharmaceuticals, LLC:

MCP Pharmaceuticals is an integrated specialty healthcare company that specializes in sterile injectable products. MCP manufactures and sells brand aseptic injectable pharmaceuticals in hospital and clinical settings and provides contract manufacturing services for global pharmaceutical companies. MCP’s own product portfolio includes leading diagnostic, women’s health and anesthesia products. All products have a long track record of “gold standard” service and are at or near the front line of treatment in their therapeutic indications. Contract manufactured products include some of the leading global biologic products which involve liquid, lyophilized and suspension presentations.

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