Associate Director, MTS (Manufacturing Technical Support) in Cranbury Township, NJ at Apex Life Sciences

Date Posted: 10/9/2018

Job Snapshot

Job Description


Associate Director- Manufacturing (Biologics Technical Support)

Position Responsibilities:

  • Lead a multi-disciplined group responsible for process engineering, equipment qualification, tech transfer, and process scale-up
  • Manage creation of RFP's and URS' for customized automation and integration of packaged systems such as single use bioreactors and upstream equipment, chromatography systems, TFF systems, and depth filtration systems
  • Lead evaluation of electronic systems for manufacturing operation including a process historian data acquisition system in the context of 21 CFR Part 11 compliance
  • Execution of site VMP to ensure a constant state of compliance in a multi-product/ multi-phase Manufacturing facility
  • Manage coordination of equipment qualification and validation program
  • Manage drafting, review, and/or approval of documentation, including but not limited to validation/qualification protocols, master batch records, standard operating procedures, production bill of materials, process flow diagrams, sampling plans, and campaign summary reports
  • Troubleshooting of all equipment and processes
  • Manage investigations of process and equipment related deviations
  • Serve as the MTS representative on the Change Control Review Committee and other committees and task forces as assigned by the Vice President, Manufacturing
  • Ensure seamless and rapid technology transfers from Process Development to Manufacturing
  • Team with PD to draft and review/approve technology transfer protocols
  • Lead and/or support activities in participation on project development teams
  • Provide technical support to Quality for the material specification process
    • Review and approval of material specifications for completeness and accuracy.
    • Provide technical advice on raw material monographs to ensure compliance with applicable region's compendia
  • Compilation of process data from clinical batches to establish critical processing parameters and PAR
  • Team with PD to lead data review meetings and provide data analysis

Requirements:

  • B.S. or M.S. in Chemical Engineering, Life Sciences or equivalent
  • 8+ years progressive industry experience with biologics drug substance scale-up and manufacturing
  • Demonstrated ability in clinical cGMP bioprocess operations, particularly processes of mammalian expressed glycoproteins, mAbs, or ERTs
  • Knowledge of process scaling from process development to clinical manufacturing to commercial manufacturing
  • In-depth knowledge of single-use technology
  • Working knowledge of equipment qualification and process validation including 21 CFR Part 11 compliance
  • Experience with development or manufacturing as it relates to biosimilars is a plus
  • Excellent communication skills, both verbal and written
  • Ability to interface effectively with analytical, process, business development, manufacturing, sales and marketing, and administration departments
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized and able to work independently and in teams
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done
  • An assertive, take-charge, proven leader with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done; however with the ability to listen, learn about, and build upon organizational best practices and successes
  • A mature thinking and acting leader with good common sense and judgment, and a broad business perspective to build, motivate, and manage a strong MTS organization
  • A solid people manager who can also serve as a team mentor and staff developer

For immediate consideration please email your resume to ESchaffer@apexlifesciences.com with the subject 'Associate Director'

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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 844-463-6178.

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 844-463-6178.




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