Sr. Associate, Manufacturing Operations (CMOs, Vendor Management, CMC, Validation, Tech Transfer) in Gaithersburg, MD at Apex Life Sciences

Date Posted: 8/9/2018

Job Snapshot

Job Description


We are searching for a Sr. Associate-Manufacturing Operations to join a rapidly growing team for one of our Pharmaceutical clients in Gaithersburg, MD!  This is a direct hire opportunity with opportunity for much growth within the organization!  (CMOs, Biologics, Tech Transfer, Validation, Product development, Manufacturing, Pharmaceutical)

SUMMARY:

Technical and Scientific oversight of Manufacturing Operations for all marketed products, including routine commercial manufacturing activities, technology transfers, and process and equipment validations.  The group works externally with Contract Manufacturers and internally with all levels of the organization to ensure delivery of a consistent and reliable supply of drug product that meets GMP specifications over the product lifecycle.

Under the direction of the Senior Manager, Manufacturing Sciences, the Senior Manufacturing Operations Associate will coordinate manufacturing activities carried out by Contract Manufacturers (CMOs) for assigned commercial products.  The position will support process investigations for manufacturing-related issues and is expected to evaluate and resolve technical problems of moderate complexity.  The Senior Manufacturing Operations Associate will also support continuous improvement initiatives by researching products/processes identified as needing improvement, recommending strategies for improvement, and supporting the implementation of those strategies once approved.

ESSENTIAL FUNCTIONS:

  • Supports the Senior Manager, Manufacturing Sciences, with the technical and scientific oversight of manufacturing operations for assigned marketed products.
  • Works with external contacts (Contract Manufacturers, Labs, etc.) and collaborates cross-functionally with Quality Assurance, Supply Chain, and Scientific Affairs groups to ensure the timely execution of cGMP activities in manufacturing operations.
  • Functions as a technical and scientific resource in support of manufacturing activities at Contract Manufacturing Organizations (CMOs).  Leverages technical expertise in support of manufacturing process evaluations, technology transfers, process validations, training, Regulatory/CMC support, and in support of Health Authority inspections.
  • Engages with Contract Manufacturers to troubleshoot and effectively resolve technical and scientific problems using Engineering and Scientific principles. 
  • Actively participates in investigations of deviations and variations in Manufacturing and/or Packaging that relate to equipment and process issues.  Contributes to the development and implementation of corrective actions to unplanned (atypical) manufacturing events.
  • Supports investigations into product technical complaints. 
  • Compiles process and product data obtained from Contract Manufacturers and ensures that data are formatted appropriately for analysis. 
  • Assesses the technical and operational feasibility of change controls for assigned products.
  • Actively participates in the creation and revision of production documentation, protocols, reports and other GMP documents by Contract Manufacturers.  Reviews and provides feedback on Validation and Manufacturing procedures, Master Batch Records, protocols, and CMC studies. 
  • Contributes to the production portion of the Chemistry, Manufacturing, and Controls (CMC) section of Regulatory Submissions and attends Regulatory meetings as the technical product owner.
  • Reports on the status of Commercial Manufacturing activities at internal meetings.  May periodically present on the status of major projects to the Senior Leadership Team.
  • Assists with the design and execution of shipping validation studies. 
  • Coordinates finished product logistics and release with Supply Chain and QA, respectively.

REQUIREMENTS:

  • BS/BA OR Associates degree in Biological Sciences, Chemical Sciences, Engineering or Equivalent technical discipline. 
  • 3-5 yrs. Exp. in Pharmaceutical Production Lifecycle Management including:
    • Product development
    • Manufacturing processes
    • Validation
    • cGMPs
    • FDA regulations for Pharmaceutical industry
  • 2-3 years interfacing or working with Contract Manufacturing Organizations (CMOs)
    • Technical transfer
    • Validation
  • Working knowledge of Quality Systems such as Deviation, CAPA, Change Control Systems

For immediate consideration please forward a copy of your resume to Jessica Corliss at JCorliss@apexlifesciences.com!

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.