Production Supervisor

US-WI-Madison
Req No.
2017-1971
Category
Manufacturing Operations
Type
Regular Full-Time

Summary of Major Responsibilities

The Production Supervisor will supervise, lead, train and assist a team in reagent manufacturing, dispensing using manual or automated processes, and packaging of final product.  This position will assist in developing and documenting new procedures for Production as well as updating work instructions and processes streamlining the overall production.  This position will be responsible for equipping, staffing and establishing systems for operations functions working closely with Production leadership and coordinating efforts. This is a first shift position with the potential for a modified shift in the future to accommodate business growth.

Essential Duties and Responsibilities

  • Develops day to day Production schedule, assigns personnel to complete scheduled tasks, and ensures on-time execution, coordinating with planning, Quality Control, and Quality Engineering.
  • Coordinates cleaning, maintenance and calibrations with facilities, metrology and engineering functions to not impact day to day operation.
  • Reviews, updates and develops SOPs, workflows, and training programs related to Production processes. Keeps all documentation up to date to meet the Quality Manual System and regulatory requirements.
  • Develop staff, maintain job descriptions, conduct 1:1s and performance reviews and manage tasks and duties for the team.
  • Provides leadership for all personnel within the Production team in order to ensure the successful, effective, efficient and safe preparation of quality finished goods.  Leadership capabilities include mentoring, motivating, coaching and providing direction and clarity to employees.
  • 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.
  • Assist in qualifying and validating manufacturing equipment and processes.
  • Address investigations, non-conformances, and CAPAs as they relate to operations production areas.
  • Manage KANBAN inventory related to the Production areas.
  • Maintain performance metrics and productivity metrics to drive process improvements and ensure visibility to leadership and staff.

Occasional Duties and Responsibilities

 

  • Individual will lead the team in continuous improvement projects and support other areas needs dependent on demand.
  • Performs other related duties as assigned by management.

Qualifications

Mandatory Skills

 

  • Evidence of 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 other teams.
  • Ability to accurately follow procedures with minimal direction.
  • Able to communicate clearly to other depts. as necessary to drive alignment and visibility.
  • Strong leadership capability and ability to mentor and train others. 
  • Demonstrated ability to develop/transfer and thoroughly document new processes and production procedures.
  • Strong documentation, attention-to-detail and procedure writing skills suitable for a GMP environment.
  • Experience in a GMP and/or ISO 13485 environment. 
  • Experience supervising a team and overseeing multiple projects with a strong ability to troubleshoot issues.
  • Excellent oral and written communication, strong interpersonal skills.

 

Preferred Qualifications:

  • Experience in a biotech manufacturing environment. .
  • Experience with ERP systems such as SAP.

 

Education and Experience

  • Bachelor’s degree in Life Sciences, or related field or the equivalent combination of education and experience.
  • Minimum of 3 years’ leadership experience. Experience managing in a GMP manufacturing environment preferred.
  • Hands-on experience in molecular biology techniques.
  • Experience in using basic software applications including Microsoft Office.

Physical Requirements

  • Ability to frequently and accurately communicate with employees and teams working different hours.
  • Ability to utilize lab equipment and moving machinery for extended periods of time (includes pipetting, traying robots etc.).
  • Ability to use and wear safety protective gear/equipment (e.g. safety glasses, lab coat, gloves, beard nets, hair nets, booties, hearing protection, etc.) and follow safety guidelines while in the lab etc, for extended periods of time
  • Ability to work at a laboratory bench or fume hood for extended periods of time.
  • Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste.
  • Ability to use computers daily in an interactive manner for extended periods of time.
  • Ability to sit, stand and/or walk for extended periods of time.
  • Ability to travel (by land) on occasion.
  • Constant walking or motion to coordinate work and interact with employees.
  • Ability to perform fine manipulation and simple grasping using hands for extended periods of time.
  • Ability to lift and move up to 40 pounds on an occasional basis.
  • Regularly sets up, adjusts, assembles, controls, tests, positions and operates objects and equipment weighing up to 20 pounds.

 

Exact Sciences is 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. The Company’s affirmative action program is available to any applicant or employee for inspection upon request.

 

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