Lead Production Associate

    • Madison, WI

Summary of Major Responsibilities

The Lead Production Associate requires a variety of skills necessary for Production Operations activities. This role will lead a variety of Production functions, including reagent production, process development, characterization, and validation. The position will work within defined protocols and procedures and may develop and document new procedures for Production. The Lead Production Associate is expected to possess a thorough understanding of laboratory procedures and conduct work within cGMP guidelines.

Essential Duties and Responsibilities

  • Lead complex Production activities, such as Capture Beads, Automated Fill / Cap / Label, Industrial Label Printing, Complex Buffers, and Hemoglobin Plates.
  • Develop Production Associates via operator training/certification programs, acting as a certified trainer.
  • Participate in developing, transferring, scaling and validating manufacturing processes, in accordance with company procedures, cGMPs, FDA, and ISO 13485 guidelines.
  • Responsible for driving process improvements, through the Change Request / Change Order process, or via other means.
  • Generate Nonconforming Material Reports, Process Change Orders, Out of Specifications, Investigations, and Corrective Actions including any deliverables associated with these items. 
  • Manage inventory via KANBAN system for raw materials, intermediates, disposables and spare parts related to the Production areas.
  • Participate with generating performance metrics and productivity metrics to drive process improvements and ensure visibility to leadership and team.
  • Generate the weekly Production assignments, following the pre-set plan established by Production management.  
  • Individual will lead continuous improvement projects and support other areas needs dependent on demand.
  • Evidence of strong analytical and problem-solving skills, ability to make rational decisions with limited information and operate independently.
  • Strong communication skills and ability to coordinate work with other teams.
  • Strong documentation skills and attention to detail necessary in a GMP environment. 
  • Leadership capability and ability to mentor and train others.
  • Capability to develop, transfer and thoroughly document new processes and production procedures.
  • Experience overseeing multiple projects with a strong ability to troubleshoot issues. Ability to plan, schedule and carry out work for successful project completion.
  • Ability to follow written procedures with minimal direction.
  • Demonstrates a basic theoretical understanding of the work tasks assigned.
  • Ability to complete assignments in expected time frames and independently seek out additional work with tasks are completed ahead of time.
  • Ability to troubleshoot and problem solve to initiate corrective action.
  • 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 work designated schedule.
  • Ability to work nights and/or weekends.
  • Ability to lift up to 40 pounds for approximately 25% of a typical working day.
  • Ability to work seated for approximately 20% of a typical working day. Ability to work standing for approximately 80% 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 50% 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 work on a computer and phone simultaneously.
  • Ability to use a telephone through a headset.
  • Ability to comply with any applicable personal protective equipment requirements.
  • Ability and means to travel between Madison locations.
  • Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

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Qualifications

Minimum Qualifications

  • Bachelor’s degree in life sciences or related field or an Associate’s degree in life sciences or related field and 2+ years of experience in lieu of a Bachelor’s degree.
  • 3+ years of experience in a relevant manufacturing setting.
  • 1+ years of coaching or mentoring.
  • Experience in using basic software applications including Microsoft Office.
  • Strong documentation skills and attention to detail necessary in a GMP environment.
  • Ability to understand and independently apply GMPs to everyday work with regard to documentation and instrument use.
  • Ability to utilize MS-Excel or MS-Word to perform basic calculations, tabulate data and prepare data.
  • 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, preferably in a GMP and/or ISO 13485 environment.
  • Project management experience.

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.


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