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Director, Internal Oligonucleotide Manufacturing Services

Exact Sciences Corporation

This is a Full-time position in Phoenix, AZ posted October 31, 2021.

The Director, Internal Oligonucleotide Manufacturing Services will oversee manufacturing of custom GMP oligonucleotides supporting IVD products and NGS platforms.

This position will provide strategic on-site leadership for the oligonucleotide manufacturing function by defining the strategy and roadmap for investment in people, process, and infrastructure to support rapid business growth and the creation of an oligonucleotide manufacturing service center of excellence.

The Director, Internal Oligonucleotide Manufacturing Services will define the layout of the manufacturing operation for the initial offering and long-term growth, will design the internal customer service offering, lead initial troubleshooting of nonconformances or out of specifications, and will lead the implementation and documentation strategies for new procedures, systems, and processes designed to increase quality and efficiency.

This role is located in Phoenix, Arizona.

Essential Duties and Responsibilities

• Initial staffing and equipping of the manufacturing operation leading up to additional shifts based on business needs and drivers.

• Development and implementation of internal ordering capability and infrastructure, from order receipt through manufacture and quality control testing to release.

• Partner with internal and external teams to implement, scale and improve oligonucleotide manufacturing processes.

• Hire and retain key talent to meet strategic and tactical goals.

• Develop metrics and key performance indicators critical to Operations success.

• Support, facilitate, identify, and lead continuous improvement or efficiency initiatives within a cross-functional team to improve COGs, drive reliability in processes and procedures, and deliver quality and productivity within Operational settings collaborating with key stakeholders including Finance partners to quantify savings.

• Manage and support generation of departmental budget and allocate resources per company objectives.

• Provide clear communication across the Operations organization aligning on expectations, goals, objectives, and project deliverables to ensure success for employees and company initiatives.

• Provide visibility and supporting information to assist leadership in prioritization of projects and efforts based on changing needs, resource capacity constraints, risk exposure, and ensuring clarity in project interdependencies.

• Stay informed of industry leading trends and new solutions being applied with the ability to analyze for possible application and implementation internally.

• Develop flexible, but consistent processes to support clear expectations regarding communication and manufacturing deliverables to all levels within the organization.

• Collaborate with Manufacturing Sciences, Tech Transfer, and Validation team in developing, transferring, scaling and validating manufacturing oligonucleotide manufacturing processes in accordance with company procedures, cGMPs, and regulatory (e.g., FDA, ISO) guidelines.

• Support efforts related to specifying, procuring, installing, qualifying and assisting in the validation of manufacturing equipment and processes.

• Ensure clear communication of requirements to Buyers, Metrology, and Engineering teams for adequate inventory availability of raw materials, intermediates, disposables and spare parts within a dynamic work environment.

• Oversee investigations, non-conformances and out of specifications associated with operational processes documenting root cause using quality system tools (5 Whys, FMEA, fishbone diagrams etc.).

• Oversee and support quality training for all employees within the function, following best practices to drive first time right production and batch record documentation.

• Support CAPAs and deviations across operational teams partnering with cross-functional areas to drive resolution.

• Ensure systems are in place to monitor performance in production to drive robustness.

• 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.

• Maintain morale and support employee engagement initiatives.

• Strong analytical and problem-solving skills.

• Ability to work effectively in team situations as well as independently.

• Excellent leadership skills to be a leader for a diverse team of individual contributors and people leaders with specialized expertise.

• Ability to effectively communicate to all levels within the company and thrive in a fast-paced, ever
– changing environment.

• 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.

• Ability to lift up to 40 pounds for approximately 5% 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 Phoenix, AZ locations.

• Ability to travel 10% of working time away from work location, may include overnight/weekend travel.

Qualifications

Minimum Qualifications

• Bachelor’s degree in chemistry, biochemistry, molecular biology or a field related to the essential duties of this role.

• 10+ years of experience in an oligonucleotide manufacturing service environment.

• 8+ years of direct and indirect management experience in a manufacturing environment.

• 5+ years of experience in a GMP (FDA and/or ISO13485) environment

• Strong proficiency in oligonucleotide manufacturing techniques.

• Strong proficiency in budgetary planning in a Production/Operations setting.

• Proficient in basic software applications including Microsoft Office.

• 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

• MS or PhD in chemistry, biochemistry, molecular biology or related field. 

• 7+ years of experience with Project Management principles and practice. 

• 2+ years of experience with next-generation sequencing technology

• Professional working knowledge in basic and advanced continuous improvement methodologies/ principles such as LEAN Six Sigma and/or Practical Process Improvements (PPI).

• Experience with SAP.

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