ATCC

  • Director, Manufacturing

    Job Locations US-VA-Manassas
    Job ID
    2018-2035
    Department
    Operations Management
    Posted Date
    5/30/2018
  • 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.


    The Director, Manufacturing is responsible for all day-to-day cell and micro manufacturing, process improvement and technical transfer activities relating to ATCC products. This is to be accomplished through leadership, management and communication within a highly dynamic function in order to meet functional and corporate metrics and goals.  Responsibilities include development and execution of strategic operating and personnel plans that ensure Operational Excellence in all functional areas, responding appropriately to changing business conditions with respect to Manufacturing and effectively managing, motivating, coaching, evaluating and rewarding staff.  The Director, Manufacturing works closely with cross-functional units such as Quality Assurance, Quality Control, Regulatory, Finance, IT and HR in order to meet functional and corporate objectives.  This position is responsible for maintaining quality standards within the function including ISO standards and compliance with key US and foreign regulations that affect ATCC products and customers.  The incumbent supports, complies with and enforces all ATCC corporate and program policies and procedures.

    The Director, Manufacturing must work and think independently; duties are accomplished primarily autonomously within established guidelines. Erroneous decisions have a serious impact on the overall success of Organization operations. The incumbent has authority either directly or through recommendations for employment decisions to include selection, training, performance evaluations, counseling, promotions and terminations. This position requires discretion in handling some assigned responsibilities including the ability to resolve problems and exercise good judgment while maintaining confidentiality.  Expectations are that the Director, Manufacturing will consistently set and achieve time, budget and quality metrics and goals that produce measurable organizational improvements.

     

    Responsibilities

    1. Develop and execute a manufacturing strategy that balances functional and Corporate priorities and resources in order to meet production, budget and quality goals for both internal and external customers. This position is accountable for meeting production demand that supports Corporate top line and improving efficiency to drive bottom line growth.
    2. Build and lead a manufacturing function leadership team that drives a positive culture of Operational Excellence and Continuous Improvement through industry standards (Six Sigma and Lean Manufacturing) and demonstrates measurable improvement based on metrics.       Ensure that the Manufacturing Leadership team owns and drives Performance Management best practices throughout the function.   
    3. 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 and foster a lean manufacturing culture.
    4. Drives accountability within the function for adherence to established Standard Operating Procedures (SOPs) and Quality Systems and creates a culture where Continuous Improvement to reduce time and effort while maintaining quality is the norm
    5. Lead from an expectation that ensures Quality, Compliance and Safety in all production activities. Ensure operation runs efficiently, effectively and consistently within compliance of ISO regulations and defined Standard Operating Procedures.  Ensure associated equipment and facilities are maintained to meet or exceed Quality System requirements and that the facility is clean and well organized.
    6. 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.
    7. Foster and maintain a culture of technology sensing, testing and integration in order to continuously modernize and improve manufacturing processes
    8. Actively participate in functional and cross-functional activities such as budgeting, site audits, capacity planning, sales and operations planning and other audit and planning activities as they pertain to the manufacturing function
    9. Effectively and efficiently, communicate both up and down within the manufacturing function. Escalate issues appropriately and in a timely manner in order to maintain schedules, metrics and goals. Establish strong cross-functional communication and working relationships based on a commitment to teamwork and mutual accountability to ensure alignment on functional goals.
    10. 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 appropriately addressed
    11. Establish a strong and trusted presence on the shop floor as well as availability practices to ensure issues or concerns are raised in a non-threatening/open environment
    12. Carries out supervisory responsibilities in accordance with ATCC’s policies and applicable external regulations
    13. Other duties as assigned

    Qualifications

    EDUCATION and EXPERIENCE: 

     

    • Master’s degree (MA) or equivalent in science and/or engineering with 15+ years related experience
    • A successful history of taking on roles of increased responsibility and accountability

    • Six Sigma Certification Green Belt

    • Prior experience leading multi-product technical biomanufacturing operations at the management level; minimum five (5) years of direct and indirect supervisory experience within a tiered organization

    • 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 ISO 9001 certified facility, knowledge and experience in aseptic manufacturing that includes both manual and automated filling operations
    • Self-starter, motivated and takes initiative; strong interpersonal, communication and problem-solving skills; able to work collaboratively with all levels of leadership and staff to resolve problems and external partners to maximize performance, creativity, problem solving and results
    • Working knowledge of cell and/or micro culture and scale up methods
    • Experience in a manufacturing environment that produces and utilizes SOPs, batch records, deviations, change control, equipment FAT, IQ/OQ/PQ, equipment calibration and other Quality Systems documents and procedures
    • Ability to work and communicate effectively and make informed decisions under time constraints and in ambiguous situations
    • Ability to define problems, collect data, establish facts, and draw valid conclusions. Seeks, learns, and applies new skills/knowledge to perform job responsibilities
    • Ability to read, analyze and interpret common scientific and technical journals, business plans, financial reports, legal agreements and other documents to include the interpretation of an extensive variety of information and/or instructions in verbal, mathematical or diagram form and deal with several abstract and concrete variables
    • 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 respond to common inquiries or complaints from customers, regulatory agencies or members of the business community
    • 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, 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)
    • 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, ERP and procurement systems software

     

    Preferred Qualifications:

    • Experience in manufacturing both cell and microbes at scale required for commercial distribution
    • Experience in an ISO 13485 or GXP certified manufacturing facility
    • Six Sigma Black Belt
    • Prior 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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