ATCC

  • Director, Manufacturing

    Job Locations US-VA-Manassas
    Job ID
    2018-2035
    Department
    Operations Management
  • Overview

    Founded in 1925, ATCC is a non-profit organization with a mission to acquire, authenticate, preserve, develop, standardize, and distribute biological materials and information for the advancement and application of scientific knowledge.


    Works closely with Quality Systems, MSAT, Finance and Human Resources. The Director, Manufacturing is responsible for day-to-day manufacturing activities, process improvements and technical support of the ATCC product line produced in Manassas, VA.  Overall responsibilities include ensuring Operational Excellence in functional areas, develops strategic operating plans and responds to changing business conditions with respect to Manufacturing, directs the development of the manufacturing build plan, collaborates with MSAT on effective transfer and introduction of new products and processes into Manufacturing, develops and maintains an organization design that is aligned with the achievement of overall business objectives and meeting customer demands and demonstrates an understanding of key US and foreign regulations affecting Manufacturing Operations ensuring compliance with those regulations. The incumbent supports, complies with and enforces all ATCC corporate and program policies and procedures.

     

    This position must work and think independently; duties of this position are to be completed under minimal guidance. Erroneous decisions have a serious impact on the overall success of Organization operations. Discretion in handling assigned responsibilities, including the ability to resolve problems and exercise good judgment while maintaining confidentiality.  Functions are to be completed in a timely manner with acceptable quality.

    Responsibilities

    1. Lead all product formulation and finishing.       Ensure associated equipment and facilities are maintained to meet or exceed Quality System requirements and that the facility is clean and well organized. Areas of assigned responsibility may be changed at the discretion of leadership based on business needs.
    2. Lead from an expectation that ensures Quality, Compliance and Safety in all production activities.   Ensure operation runs consistently within compliance of ISO regulations and defined Standard Operating Procedures.
    3. Identify and select colleagues who have the right skill set and commitment to meeting elevated standards and our quality system requirements. Develop a culture that is positive and promotes engagement while maintaining an appropriate balance with respect to accountability.
    4. Establish strong working partnerships based on a commitment to teamwork and mutual accountability to ensure alignment on production goals. Establish production goals and schedules to ensure customer requirements are met.
    5. Drive efficiency through establishing realistic budgets, maintaining accurate bills of materials and driving cost saving initiatives. Identify and drive key variances (labor, material, scrap) to ensure operations are favorable to budget.
    6. Support investigations using proven techniques such as Six Sigma to solve problems. Monitor effectiveness of preventive actions and take action to ensure repeat failures are addressed.
    7. Establish and maintain baseline metrics in the areas of Quality, Cost, Efficiency and Delivery. In partnership with key stakeholders, develop and implement projects to drive improvements based on organizational priorities. The overall effort should be consistent with Lean Manufacturing Principles and serve to establish a lean manufacturing culture.
    8. Support and drive change within the operation by establishing partnerships with peers, cross functional stakeholders, assigned staff and shop floor colleagues to align their actions with the process improvement efforts. In partnership with leadership, peers and stakeholders pursue of culture of Continuous Improvement through implementation of 6 Sigma and Lean Manufacturing.
    9. Provide hands on leadership and a relentless focus on the details of product manufacture.   Establish a strong and trusted presence on the floor so as to ensure issues or concerns are raised in a non-threatening/open environment.
    10. Carries out supervisory responsibilities in accordance with ATCC’s policies and applicable external regulations. Has authority either directly or through recommendations for employment decisions to include selection, training, performance evaluations, counseling, promotions and terminations
    11. Must be able to work closely and communicate with other departments.
    12. Must be able to interface with regulatory agencies for site audits.

    Qualifications

    EDUCATION and EXPERIENCE: 

    • Master’s degree (MA) or equivalent in science and/or engineering with 15+ years related experience.
    • Six Sigma Certification Green Belt.
    • Prior experience leading technical manufacturing operations at the management level; minimum five (5) years of supervisory experience.

    KNOWLEDGE, SKILLS and ABILITIES:

    • Experience in an FDA regulated industry and working knowledge of GMPs.
    • Knowledge and experience in Aseptic Manufacturing to include filling operations.
    • Experience in both manual and automated Packaging Operations.
    • Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents to include the interpretation of an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
    • Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
    • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations – as well as apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance correlation techniques, sampling theory, and factor analysis of intellectual and practical problem.
    • Ability to define problems, collect data, establish facts, and draw valid conclusions.
    • Self-starter, motivated and takes initiative; strong interpersonal and problem-solving skills; able to work collaboratively with all levels of staff to resolve problems and external partners 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 strong project management skills.

    • Resourceful, diplomatic and professional; deliver outstanding customer service while managing relationships; a can-do attitude and work style that supports teamwork and lead teams when necessary, collaboration and positive relationships.
    • Adaptable; be able to shift priorities and focus as departmental and/or business demands change (including, but not limited to early/late hours and/or weekend hours).

    • 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 and procurement systems software.
    • Follow all company safety practices, Standard Operating Procedures (SOP’s) and policies.

    Preferred Qualifications:

    • Black Belt preferred.
    • Prior experience leading or supporting lean manufacturing implementation preferred.

       


     

    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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