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Production Scientist

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Company :
Exact Sciences Corporation

Location :
Madison, Wisconsin

Expiry Date :
Sat, 06 Feb 2021 23:59:59 GMT

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Description :
SunIRef:Event141 Summary of Major Responsibilities: The Production Scientist will lead, train, and assist a team in reagent manufacturing and dispensing using manual or automated processes. This role may also lead, train, and assist with packaging of final product. This position will take a lead role in updating work instructions and processes streamlining the overall production process. This position will lead and assist projects or initiatives to drive performance and improve efficiency within the Production department, working closely with Production leadership and coordinating efforts. The Production Scientist is expected to possess an extensive understanding of laboratory procedures and conduct work within cGMP guidelines. This role will lead through influence of indirect team members and may also provide direct leadership oversight for a role or small team. Essential Duties and Responsibilities: Develop the day-to-day Production schedule, assign personnel to complete scheduled tasks and ensure on-time execution, coordinating with planning, Quality Control, Quality Engineering, and other Production leadership. Lead in the generation and timely execution of Production operator training schedules, ensuring alignment with the Production schedule. Perform classroom and on-the-job training of Production staff. Review, update, and develop SOPs, workflows and training programs related to Production processes. Keep all documentation up-to-date to meet the Quality Manual System and regulatory requirements. Lead efforts to improve classroom and on-the-job training of Production staff. Provide in-lab leadership as a technical expert for all personnel within the Production team to ensure the successful, effective, efficient, and safe preparation of quality finished goods. Act as Subject Matter Expert (SME) on core functions of the Production organization (e.g., reagent manufacturing, product finishing). Mentor, motivate, coach, and provide direction and clarity to other Production staff. Lead or assist execution of investigations, non-conformances, and CAPAs as they relate to operations production areas. Develop performance metrics and productivity metrics to drive process improvements and ensure visibility to leadership and team. Lead efforts or projects to maintain or improve laboratory support processes, such as laboratory stocking or laboratory cleaning. Represent Production in routine cross-functional team settings (e.g., Material Review Board) or on project-based teams. Act as a lead in continuous improvement projects. Assist in developing, transferring, scaling, and validating manufacturing processes, including formulation, filling, labeling, and packaging, in accordance with company procedures, cGMPs, FDA and ISO 13485 guidelines. Strong analytical and problem-solving skills; ability to make decisions with limited information and operate with autonomy. Strong communication skills and ability to coordinate work with other Production leadership. Ability to accurately follow procedures with minimal direction. Ability to communicate clearly to other depts. as necessary to drive alignment and visibility. Excellent oral and written communication, strong interpersonal skills. Strong ability to mentor and train others. Strong documentation, attention-to-detail, and procedure writing skills suitable for a GMP 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. Attend work regularly and reliably. Ability to comply with any applicable personal protective equipment requirements. Ability to use various types of laboratory equipment including overhead mixers, scales, automated filling equipment, and pipettes for extended periods of time. Ability to work at a laboratory bench or fume hood for extended periods of time. Ability to work in a lab environment that will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 50% of a typical working day. Ability to work seated for approximately 50% of a typical working day. Ability to work standing for approximately 50% of a typical working day. Constant walking or motion to coordinate work and interact with team members. Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height. Ability to lift up to 40 pounds for approximately 5% of a typical working day. Ability to lift up to 20 pounds for approximately 10% of a typical working day. Ability and means to travel between Madison locations. Qualifications: Minimum Qualifications Bachelor’s degree in Life Sciences, or other field related to the essential duties of the position; or high school degree/general education diploma and 4 years of relevant experience in lieu of Bachelor’s degree. 5+ years of relevant work experience. 3+ years of experience mentoring or coaching team members in a laboratory or project management setting. 2+ years of experience in a GMP and/or ISO 13485 environment. Advanced experience in using 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 Experience in a biotech manufacturing environment. Experience with ERP systems such as SAP. EEO Disclosure: 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.