The Manager, Production will lead, train, assist and support teams in labeling, reagent manufacturing and dispensing, kitting and packaging as well as drive process improvements, lean manufacturing philosophy, validation and transfer of new processes and systems into production. This position will lead or support the teams in developing and documenting new procedures for each work-stream. The Manager, Production will lead or support equipping, staffing and establishing systems for labeling, production and dispensing including work-in-process and finished goods kitting and packaging assembly. This position will lead investigations and non-conformances associated with processes within their work-stream as well as support other Supervisors within the area.
Essential Duties and Responsibilities
Collaborate with Manufacturing Sciences, Tech Transfer and Validation team in developing, transferring, scaling and validating manufacturing processes, including formulation and dispensing, in accordance with company procedures, cGMPs, FDA and ICH guidelines.
Represent Production in routine cross-functional team settings (e.g. Material Review Board) or on project-based teams.
Specify, procure, install, qualify and assist in the validation of manufacturing equipment and processes.
Manage schedule of production work closely with Production Planner.
Ensure inventory of intermediates, disposables and spare parts are available for work-streams coordinating with Buyers, Metrology and Engineering.
Coordinate, lead, and support process improvement projects.
Assist and/or lead investigations associated with production processes.
Assist and/or lead in budget planning activities.
Lead and/or support activities or projects designed to maintain employee engagement and facilitate development of non-production related skills.
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.
Strong analytical and problem-solving skills.
Ability to make decisions with limited information and operate with autonomy.
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.
Ability to work effectively in team situations as well as independently.
Excellent oral, written communication and interpersonal skills.
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 5% of a typical working day.
Ability to work with hazardous or flammable materials (e.g. chemicals, radioactivity, electrical equipment) so as not to endanger oneself or others.
Ability to work seated for approximately 70% of a typical working day. Ability to work standing for approximately 30% 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 80% 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.
Qualifications
Minimum Qualifications
Bachelor’s degree in Life Sciences or related field; or an Associates degree and 2+ years of experience in lieu of a Bachelor’s degree.
8+ years of experience in a manufacturing or life sciences environment.
3+ years of direct management experience in a manufacturing environment.
Professional working knowledge in molecular biology techniques.
Professional experience with budgetary planning in a Production/Operations setting.
Experience leading diverse teams.
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
Experience in a biotech manufacturing environment, GMP and/or ISO13485 environment.
Working knowledge of PCR and molecular biology.
Experience with SAP.
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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.
