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Manager, Manufacturing - Fractionation (Night Shift)
The position will support the development of a new, state-of-the-art plasma fractionation facility that will bring the company additional capacity for fractionation, purification, and fill and finish for its biologic medications. Through subordinate supervisors, manages shift or multiple shift operations within the manufacturing department. Responsible for meeting budget, quality, and production goals, setting standards, and making employment and staffing decisions. Interprets manufacturing policies, procedures, and programs.
Responsible for meeting production plan & delivering high quality products to customers in a timely fashion and cost-efficient manner.
Supervise the daily manufacturing operations for their respective shift and cell.
Emphasize training and implement control systems on the shift to eliminate product discrepancies.
Lead and support manufacturing event investigations from initiation to closure in a timely manner to assure compliance with plan. Serve as Manufacturing main point of contact / SME for product impact decisions as appropriate.
Drive and ensure the right KPIs are implemented and tracked on a regular basis for their shift and cell responsibility.
Lead by example and maintain production floor presence and focus. Mentor junior level personnel on projects and activities.
Coordinate necessary manufacturing resources and rally support groups to resolve production-related issues.
Rapid and relentless approach to address production-related issues by providing sustainable long-term solutions.
Conduct impartial assessment of shift performance – main priority is overall performance of applicable business unit.
Constant calibration with other managers focusing on technical background of issue as well as consequences considered when making decisions.
Commit to employee feedback and developmental processes.
Manage shift/team and investigate and resolve disciplinary issues.
Support and emphasize the Safety and Quality commitments of department.
Identify/prioritize/provide resources to assist the department director to meet the annual operating plan and budgetary commitments.
Will be responsible for driving operational excellence and flawless execution in day to day operation of the plant through Visual Management processes.
Education and Experience Requirements
Typically requires a bachelor’s degree, preferably in Science, Engineering or other related technical field.
6+ years of related experience with 3+ years in a manufacturing, supervisor role.
Key Skills, Abilities, and Competencies
Advanced supervisory and leadership skills. Must have a demonstrated track record of successfully executing within manufacturing environment supporting manufacturing/production issues, in a FDA-regulated manufacturing environment.
Experience with implementation and driving accountability through visual management
Possess knowledge of core principles in various manufacturing disciplines (i.e. cell culture / fractionation / purification / aseptic filling / packaging / cGMP facility design), support systems (WFI / RO / clean steam / compressed gases / HVAC) and facility design.
Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
Must have the ability to effectively lead manufacturing production floor and drive results. Direct experience with manufacturing operations and biotechnology processes is strongly preferred.
Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
Provide a positive and equitable working environment.
Self-driven individual that requires minimal supervision.
Ability to solve routine and challenging manufacturing problems without assistance.
Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint).
Other Job Requirements
Must be willing and flexible to work Fixed or Rotating, Day or Night, Short term, Long Term, or Permanent Shift.
Ability to travel and spend training time at sending site(s) (up to 25% of time for first year).
Must be able to lift, push, pull and carry up to 50 lbs.
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. Some clean room and cool/hot storage conditions.
No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the work environment.
May be working in a loud area that requires hearing protection and other protective equipment to be worn.
Will work around chemicals such as alcohol that may require respiratory protection.
May be required to work or be assigned to a different shift as needed.
Must be able to work overtime as required.
This job posting excludes CO applicants.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.