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Analytical Development Manager

Philadelphia Metro Area, Pennsylvania

Post Date: 03/20/2017 Job ID: JN -032017-18626 Industry: Analytical Chem - Scientific
  • Oversight to all functional Analytical Development areas
    PhD in Chemistry / Pharmaceutical sciences with 5+ years of pharma laboratory experience, coupled with a minimum of 3 year of supervisory experience

  • Manage resources and activities to complete method development, enhancement, validation and documentation for ANDAs and product launches.

  • Respond to FDA comments or deficiency letters.

  • Maintain the laboratory in compliance with SOPs, CGMPs, FDA and OSHA.

  • Investigate and troubleshoot analytical issues.

  • Review notebooks and raw data for CGMP compliance.

  • Review USP/NF supplements, PF, European Pharmacopeia and other compendia, as applicable, to provide and implement proposed recommendations.

  • Perform Critical Review of Drug Master File, Technical Packages, Raw Material Specification and Certificate of Analysis for conformance to USP for ANDA/NDA submission.

  • Write SOPs, technical documents (Finished product specifications, packaging product specification, stability specifications, test methods, protocols and reports).

  • Periodically review SOPs for compliance with CGMPs and revise SOPs, if necessary.

  • Write and execute EQ protocols and set up Qualification program for new instruments.

  • Manage calibration and maintenance on existing equipment.

  • Design of experiments including Dissolution / Drug Release procedures in support of early stage product development.

  • Ensures continuous improvement in work processes through application of statistical thinking and appropriate computer-based technology.

  • Ensures ICH and regulatory agency standards are anticipated, evaluated, and met for all development work. Take primary responsibility for the preparation and completion of CTD documentation appropriate to projects.

  • Assist the head of analytical chemistry in the effective orientation of new staff and the updating of existing staff through training in equipment use, testing procedures, and standard processes.

  • Ensure the safe operation of laboratories and respond to safety observations.

  • Ensures continuous improvement in work processes through application of statistical thinking and appropriate computer-based technology.

  • Ensures ICH and regulatory agency standards are anticipated, evaluated, and met for all development work. Take primary responsibility for the preparation and completion of CTD documentation appropriate to projects.

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