The position will support a fill/finish processing facility that is in growth mode bringing Takeda additional cGMP capacity for flexible intravenous bag production for its biologic medications. Through subordinate supervisors, incumbent manages shift or multiple shift operations within the site s manufacturing department. Incumbent is responsible for meeting budget, quality, and production goals, setting standards, and making employment and staffing decisions. Interprets manufacturing policies, procedures, and programs. Communicates seamlessly up and down the organization and is a role model for success.
The Round Lake facility is a 24/7 operation. This is a 12 hour shift 2-2-3 configuration. 5:00am - 5:30pm, OR 5:00pm - 5:30am shift. This position is for Nights.
During Qualification, Validation and Commercial Production phase:
- Advanced supervisory and leadership skills.
- Ability to interpret and analyze data and write technical reports.
- Manage multiple priorities seamlessly.
- Lead the workforce hiring process and effectively communicate work execution strategies.
- Accountable for ensuring employee work-time management software is accurate on a daily basis for manufacturing hourly employees.
- Promote and support a perfect equipment culture, by assisting maintenance team during implementation of programs such as Total Preventive Maintenance (TPM), equipment reliability, Preventive Maintenance (PM) and Predictive Maintenance (PdM) programs, etc.
- Review and approve SOPs and Job aids, associated to manufacturing processes.
- Actively drive Electronic Batch Management (EBM) process steps development and implementation.
- Support process technical transfer and any change with BOM materials.
- Drive the implementation of appropriate measures to ensure availability of all materials and consumables and lead the implementation of Kanban and 5S systems to assist from CQV to Full production environment
- Build a culture of safety first in compliance with Environmental, Health, and Safety (EHS) through all manufacturing associates and production engineers. Support development and communication of Job Hazard Analysis (JHA) packets.
- Support project deliverables to completion and meet timeline and budget objectives.
- Coordinate availability of manufacturing resources to execute qualification activities and execute production batches per schedule.
- Responsible for reviewing and modifying related training material and support training of manufacturing personnel.
- Through regular visits to the manufacturing floor (Gemba), assist in the generation of punch list on associated discrepancies and lead/support the resolution of them.
- Assist the development of Key Performance Indicators (KPI s) such as process yields, plan attainment, conversion loss, manufacturing events, safety, etc.
- Manage daily OMT meetings (shift change, daily production meeting) as required.
- Responsible for meeting production plan & delivering high quality products to customers in a timely fashion and cost-efficient manner.
- Lead the daily manufacturing operations across multiple shifts and/or department.
- Drive operational excellence on the shop floor using lean tools like 5S, Kanban, visual management, SMED.
- Emphasize training and implement control systems on the shift or multiple shifts 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 Mfg 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.
- Lead by example and production floor presence and focus. Mentor supervisors and production engineers/SMEs 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 leadership focusing on technical background of issue as well as consequences considered when making decision.
- Build trust and unwavering collaboration with key support personnel and peers.
- 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 manager 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.
- Advanced supervisory and leadership skills. Must have a demonstrated track record of successfully executing within manufacturing environment supporting production issues, in a FDA-regulated manufacturing environment.
- 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. Experience with aseptic processing, packaging machinery, programmable logic controllers, and electronic batch management systems is desirable.
- 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 emphasizing the Takeda Shared Values: Respect/Responsiveness/Results.
- Self-driven individual that requires minimal supervision
- Ability to solve routine and challenging manufacturing problems without assistance.
- Ability to travel at a minimum of 5%.
- Must have proficient computer skills and be experienced using MS Office software (Word, Excel, PowerPoint, MS Project).
Education and/or Experience:
Requires a B.S. or equivalent, with a scientific or engineering degree preferred. 3-5 years of manufacturing process experience in a regulated industry. Direct manufacturing leadership experience desired, preferably in a Superintendent, Shift Manager, or Supervisory role.
- 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.
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Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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