Pharmaceutical Manufacturing Specialist
Summit Biosciences Inc. - Lexington, KY

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Responsible for performing and leading manufacturing and validation related activities in a cGMP environment. The scope of the position includes writing and revising SOPs, Production Batch Records (PBRs), Forms and validation documents, training Manufacturing Technicians to perform work in a safe, accurate and timely manner, assuring cGMP compliance, performing routine maintenance and troubleshooting of equipment and processes, independently performing validation activities, including writing protocols and reports and compiling data and attachments into comprehensive validation packages. Also responsible for assisting with the development of processes, specifications, validation protocols and other validation and engineering related documentation. May also perform routine preventive maintenance activities and manage validation and revalidation projects.

Essential Duties:

  • Lead activities to manufacture sterile nasal spray products in a cGMP environment.
  • Maintain areas and manufacturing documentation in compliance with SOPs and cGMPs.
  • Write or revise maintenance, operating and safety procedures.
  • Coordinate planned and emergency maintenance in all assigned areas.
  • Coordinate and assist with the performance of maintenance, calibration and validation activities in the manufacturing areas.
  • Train technicians on safety, PBRs, SOPs, and cGMPs.
  • Maintain an inventory of supplies necessary for manufacturing and validation activities.
  • Assist or conduct investigations to resolve deviations.
  • Participate in administrative tasks such as budgeting, recruiting and performance evaluations.
  • Work on multiple validation projects simultaneously and coordinate test work with various other departments.
  • Write protocols and reports for manufacturing, utility and lab equipment and processes.
  • Execute validation work according to protocol instructions and procedures.
  • Plan, coordinate and track the progress of validation projects.
  • Compile validation packages and assure all required documentation is complete.
  • Review validation data for other staff.
  • Champion process improvement projects and ensure equipment and systems remain in a qualified state.
  • Assist with the implementation of a validation training program and the training of new personnel and contractors.
  • Assure compliance with quality policies and procedures related to validation activities.
  • Lead investigations related to validation deviations and assure thoroughness of investigation, identification of root cause, documentation and closure.


  • BS in Biology, Chemistry, Engineering or related science or equivalent experience
  • 3-7 years of experience in a cGMP manufacturing environment including hands-on manufacturing or validation experience
  • Experience with sterilization processes and aseptic technique preferred
  • Excellent technical writing and organizational skills
  • Good mechanical aptitude
  • Good interpersonal skills and the ability to work well in a team environment
  • Self-starting with outstanding work ethic; must be able to perform in a fast paced multi-product environment
  • Extremely detail oriented
  • Ability to work with cross functional teams and meet performance requirements

How to apply:

Please submit resume and cover letter.

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