Job Information
Mallinckrodt Pharmaceuticals Team Lead, Medical Device Production in Madison, Wisconsin
Job Title
Team Lead, Medical Device Production
Requisition
JR000014063 Team Lead, Medical Device Production (Open)
Location
CC-Madison - USA503
Additional Locations
Madison, WI
Job Description
The Team Lead, Medical Device Production provides leadership, ensures safety, quality, and productivity goals are met. The Team Lead, Medical Device Production supports GMP Manufacturing processes, handle operational tasks, and drive continuous improvement. Acting as a subject matter expert, t he Team Lead, Medical Device Production oversees equipment maintenance and effectively communicate priorities to the team. The Team Lead, Medical Device Production ensures work aligns with quality standards and regulations.
Essential Functions
Provide operational guidance for day-to-day cGMP device manufacturing production and service activities.
Make necessary judgment call to align with schedule changes by prioritizing specific duties to stay on schedule.
Communicate with production leadership and warehouse teams to ensure materials are ready and staged each day.
Oversee training of new employees
Communicates with quality and facilities any time there is an issue with the product or equipment.
Perform and document all assembly, test and repair work per established work rules, policies, and procedures.
Provide guidance in problem diagnosis and resolution with team members.
Successful completion of all training in a timely fashion.
Serve as a key part of new hire selection and onboarding process.
Assist in development and revisions of Standard Operating Procedures (SOP), Work Instructions (WI) device history records, or other quality documentation, as necessary, to support production processes.
Minimum Requirements
5+ years of experience in Medical Device cGMP manufacturing or equivalent combination of manufacturing experience.
Ability to work independently and motivate staff to meet required deadlines.
Problem solving and process improvement skills.
Demonstrated excellence in leadership, coaching and communication skills.
Ability to facilitate change, foster innovation, and achieve results.
Preferred Qualifications:
Bachelor’s degree in related field.
Strong SAP skills and experience.
Six Sigma belt or LEAN ideology.
Organizational Relationship/Scope:
The role of the Team Lead, Medical Device Production is primarily an entry level management role within the Device Manufacturing department; this position will perform hands on value-add operations for device manufacturing in addition to providing help and guidance to other team members. Work will be split between executing plant-based device manufacturing operations and providing training, assigning tasks, setting priorities with direction from site leadership, team member guidance and troubleshooting help for other team members.
Working Conditions:
Clean, temperature-controlled environment. Ability to work scheduled or expanded shifts, holidays and/or off-shift duties, as necessary.
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Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.
Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.