Senior Manager, Cell Derivation Unit

ATCC
Gaithersburg, MD Full Time
POSTED ON 12/10/2021 CLOSED ON 2/21/2022

What are the responsibilities and job description for the Senior Manager, Cell Derivation Unit position at ATCC?

Overview

 

The Senior Manager, Cell Derivation Unit is responsible for the management of the activities related to the derivation of cells from human tissue sources for the production of primary cell lines and conducting the Cell Banking activities in the generation of master and working cell banking used as the source of Biopharmaceutical production.  The Senior Manager will assure that all activities conducted within the CDU-Cell Banking facility are in strict compliance to cGMP as described by the US Food and Drug Administration and in accordance with the ATCC Quality System. 

Responsibilities

  • Oversee the isolation and culturing of primary cell lines from human tissue samples and the culturing of customer cell lines for the production of master and working cell banks; Maintain the facility to the highest level of compliance to cGMP, ATCC’s Quality System, and customer expectations; oversee general lab management.
  • Develop and maintain detailed standardized operating procedures in alignment to validated procedures and in accordance with cGMP or as described in customer-specific Statements of Work (SOW); Prepare written documentation and training as necessary to facilitate transfer of manufacturing processes to staff.
  • Ensure that all service activities are compliant with ATCC’s Safety Standards and OSHA requirements.
  • Build, train, sustain and motivate a multi technology services team capable of achieving all productivity targets and output requirements to fully meet customer expectations.
  • Maintain the certification of facility systems and equipment; assure the departmental SOP’s and Work Instructions are up to date and accurately reflect the work activity.
  • Assist in the technical transfer of new products and services.
  • Develop and manage the budget requirements for each fiscal year.
  • Ensure all company and site policies are adhered to and ensuring appropriate company disciplinary policies are followed consistently.
  • Other ancillary duties as assigned.
  • Qualifications

    Education and Experience:

    • BS/BA/MS degree in Chemistry/Life Science, Engineering or equivalent with minimum of ten (10) years’ experience, with a minimum of five (5) years’ successful supervisory experience.
    • Experience in working in BSL2 laboratories.
    • Work within a cGMP/ISO regulated environment for 10 years

    Knowledge, Skills and Abilities:

    • Experience in working in an aseptic environment.
    • Self-starter, motivated and takes initiative; strong interpersonal and problem-solving skills; able to work collaboratively with all levels of staff to resolve problems to maximize performance, creativity, problem solving and results.
    • Seek, learn, and apply new skills/knowledge to perform job responsibilities.
    • Attentive to detail with a high level of accuracy; exercise sound judgment and demonstrates leadership qualities and success in management of change.
    • Resourceful, diplomatic and professional; deliver outstanding customer service; a can-do attitude and work style that supports teamwork, collaboration and positive relationships.
    • Adaptable; be able to shift priorities and focus as departmental and/or business demands change
    • Strong analytical skills and organized; completes tasks ahead of schedule.
    • Excellent written and verbal communication skills, including excellent listening skills and presentation skills to communicate clearly, concisely and effectively.
    • Position-relevant computer experience including Microsoft Office.
    • Follow all company safety practices, Standard Operating Procedures (SOP’s) and policies.
    • Strong business orientation and financial skills.

    Preferred Qualifications: 

    • Six Sigma Certification: Green Belt/Black Belt Preferred.
    • Prior experience leading technical manufacturing operations at the managerial level.
    • Prefer experience leading or supporting lean manufacturing implementation.

    ATCC is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

     

     

     

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