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Director, BioProduction

Company: ATCC Biotechnology
Location: Gaithersburg
Posted on: January 26, 2023

Job Description:

Overview
The Director, BioProduction will establish and lead a team responsible for new product tech transfer, ATCC-catalog manufacturing, as well as documentation and process improvements. The position in located at ATCC's Gaithersburg, Maryland site.
The ideal candidate will serve as a hands-on leader in manufacturing to assess, develop, and implement process and product improvements for virology, molecular and cellular biology products. They will have demonstrated success in process development and/or scale-up, implementation of new production technology and process improvements, in building new teams as well as experience setting up new lab space. The Director will work collaboratively with Operations, Quality, Product Development, and other SMEs.
The newly established bioproduction team will collaborate to tech transfer new products into manufacturing, improve manufacturing workflows, evaluate critical attributes of key manufacturing processes, perform root cause analysis of failure modes, and create appropriate manufacturing documentation. Additional duties include defining project scope, estimating cost and timelines, and providing regular briefings to leadership and operations.
Responsibilities
The candidate for this role must work and think independently; duties of this position are to be completed under general administrative guidance. - Exceptional communication and decision-making are key components of this position, and the outcome of their decisions will have an impact on the overall success of the organization. -


  • Establish a cross-functional team dedicated to bioproduction and process improvement projects with the goal of increasing product quality, consistency, and yield
  • Demonstrate leadership and sound judgement in recruiting, managing, mentoring, and motivating staff and other resources to achieve goals
  • Build a culture committed to quality and continuous improvement, ensure accordance with applicable regulatory requirements, internal product and quality standards, and customer needs
  • Role model leader who encourages employee engagement and employee recognition
  • Develop roadmaps of emerging technology application areas for standardization readiness and impact
  • Develop, implement and manage production projects with team and direct the daily workload to ensure on-time completion while maximizing utilization and efficiency
  • Communicate pertinent corporate and departmental information to their team
  • Communicates issues to management appropriately and in a timely manner to ensure timelines, budget and goals are consistently met
  • Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. - Has authority either directly or through recommendations for employment decision to include selection, training, performance evaluations, counseling, promotions, and terminations
  • Embraces the ATCC Mission, directives, and corporate goals.

    The incumbent will be responsible for managing, motivating, developing, evaluating, and mentoring a team in alignment with ATCC performance management practices and for actively supporting, complying with, and enforcing all ATCC corporate policies and procedures. - - -
    Qualifications
    Education and Experience:

    • Bachelor's degree within molecular biology, biology, biochemistry, chemistry, or material science and 12 or more years' experience, including 6 or more years' supervisory experience or equivalent experience
    • Advanced degree in related disciplines preferred
    • Experience with process or method development and/or tech transfer is required
    • Experience in managing a team is required
    • Hands-on experience in virus production and cell culture required (BSL-1 and BSL-2)
    • Experience working with a broad set of laboratory instruments is preferred
    • Experience in statistical software (e.g. JMP) preferred
    • Experience with ERP and electronic notebooks preferred
    • Experience working in a regulated environment (FDA/USDA/GMP/ISO) is required
    • Experience in the biotechnology industry is required
    • Has analytical and statistical skills to perform data analysis
    • Strong written and oral communication skills
    • Excellent time management and project management skills
    • Excellent interpersonal skills with the ability to interact with all levels of the organization both orally and in writing; consistent track record of working multi-functionally
    • Understands good laboratory practices and good manufacturing practices
    • Ability to multitask and complete projects in a fast-paced environment
    • Must be self-motivated, meticulous, organized, a critical thinker, a problem solver, and have the ability to collaborate well with a team
    • Embraces change and is results driven
    • Proven ability to effectively manage up and down, apply discretion, maintain confidences, and demonstrate organizational savvy
    • Solid leadership, personnel management, coaching, delegating and evaluation skills
    • Strong commitment to excellence and a passion for cultivating strong cross-functional relationships and championing business growth
    • 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
    • Must be proficient in MS Office Applications

      Other Duties:

      • Perform other duties as assigned.

        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.
        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.

Keywords: ATCC Biotechnology, Washington DC , Director, BioProduction, Executive , Gaithersburg, DC

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