Exact Sciences Corporation

Associate Director, Manufacturing Sciences, NGS

Job Locations US-CA-San Diego
Req No.
2021-9393
Category
Manufacturing Operations, Facilities & Security
Type
Regular Full-Time

Summary of Major Responsibilities

The Associate Director, Manufacturing Sciences-NGS role will lead a diverse team within Operations responsible for Design Transfer of new products, post-launch product support, complex issue resolution, process improvement/enhancement, and risk mitigation activities primarily within next-generation sequencing (NGS)This role will be responsible for study design, execution, reporting and will equip, staff, and establish systems and procedures in close coordination with R&D, Manufacturing, Supply Chain, and other stakeholders.  The Associate Director, Manufacturing Sciences NGS role will oversee cross-functional projects and implement best practices to ensure the area meets business needs and will lead the Manufacturing Sciences team by setting direction and creating a work environment that encourages goal realization and employee growth.

Essential Duties and Responsibilities

  • Lead a Manufacturing Sciences team driving initiatives that align with business needs.
  • Provide technical leadership and support for NGS based reagents and products.
  • Serve as Operations core team member for new product pipeline projects collaborating with R&D in developing, transferring, scaling, and validating manufacturing processes and quality control test methods for commercial release as part of Design Transfer.
  • Oversee activities related to developing, qualifying, and troubleshooting analytical and functional test methods, manufacturing processes, and materials associated with oligonucleotides, enzymes, antibodies, and molecular biology reagents used in complex molecular diagnostics products.
  • Lead and support troubleshooting of Out Of Specifications (OOS), non-conformances (NCMRs), and corrective action preventive action (CAPA) plans through root cause investigation, experiment design, study execution, data analysis, and reporting.
  • Provide technical leadership and assistance in Supplier Change Requests (SCR), raw material feasibility, alternative supply evaluation, and risk mitigation activities.
  • Interact with vendors on a technical level to resolve challenges with raw materials or processes established and/or develop new processes to implement with our strategic partners to improve reliability of incoming materials.
  • Generate clear and accurate experimental protocols, draft procedures, characterize and develop test methods and test method improvements summarizing activities through technical or investigative reports.
  • Provide needed visibility and supporting information to assist leadership in prioritization of projects based on changing functional needs, resource capacity constraints, risk exposure, and ensuring clarity in project interdependencies.
  • Oversee design and execution of complex studies and designed experiments using appropriate statistical techniques.
  • Oversee design and execution of stability studies according to recognized standards.
  • Provide thought leadership in design for manufacturability for future products and test methods in collaboration with R&D.
  • Oversee teams conducting bench level experiments within several product or technology areas to identify problems and discrepancies.
  • Mentor next level managers and leaders within the functional work-streams to continue to grow talent within our organization.
  • Lead and manage several varied projects at one time, with frequent changing priorities.
  • Supervise staff including but not limited to organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
  • Communicate goals clearly to employees to ensure understanding and success in achieving them.
  • Motivate and inspire employees to do their best work through coaching.
  • Maintain morale and support employee engagement initiatives.
  • Communicate to all levels within the company and thrives in a fast-paced, everchanging environment.
  • Evidence of strong analytical, problem-solving skills and negotiating skills and ability to make decisions with limited information and operate with autonomy.
  • Strong documentation, attention-to-detail and procedure writing skills suitable for a GMP environment.
  • Excellent oral, written communication and strong interpersonal skills.
  • Demonstrated ability to develop/transfer and thoroughly document new processes and production procedures.
  • Ability to interpret technical data and present findings to management.
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
  • Support and comply with the company’s Quality Management System policies and procedures.
  • Regular and reliable attendance.
  • Ability to lift up to 50 pounds for approximately 5% of a typical working day.
  • Ability to utilize lab equipment for 10% of a typical working day.
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
  • Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
  • Ability to comply with any applicable personal protective equipment requirements.
  • Ability and means to travel between CA locations.
  • Ability to travel 10% of working time away from work location, may include overnight/weekend travel.

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Qualifications

Minimum Qualifications

  • Bachelor's degree in Chemistry, Molecular Biology or a field related to the essential duties of this role; or an Associate's degree and 2 years of relevant experience in Chemistry, Molecular Biology or field related to the essential duties of this role in lieu of bachelor’s degree.
  • 10+ years of experience with biochemical and molecular based products.
  • 5+ years of direct leadership experience.
  • 2+ years of experience with next-generation sequencing technology
  • Professional working knowledge in Microsoft Office.
  • Professional working knowledge with 21 CFR Part 820, ISO 13485, and/or cGMP structured environments.
  • Authorization to work in the United States without sponsorship.
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

  • 10+ years of experience with Medical Device Products in a Product Development, Product Support, or Quality Control role.
  • 7+ years of experience with Project Management principles and practice. 
  • 3+ years of experience leading or directing people and/or project teams utilizing NGS.
  • Professional working knowledge in statistical and mathematical methods in biology/genetics, including experience with JMP software.
  • Professional working knowledge in Design for Six Sigma and Statistics.
  • Professional working knowledge in basic and advanced continuous improvement methodologies/ principles such as LEAN Six Sigma and/or Practical Process Improvements (PPI).

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

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