- Delivers leadership and excellence in manufacturing processing and scheduling to meet sitedemands.
- Manages the floor operations to ensure safety and compliance with cGMPs are maintained at all times.
- Oversees the planning, implementation and maintenance of manufacturing operations for new and/or existing products and technologies in a cGMP environment.
- Collaborate with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations.
- Integrate best practices, where appropriate, into manufacturing. Ensures the efficiency of material, equipment and personnel in day to day operations.
- Monitor departmental operating expenses (OT, Equipment, Supplies) and assist in developing budgets.
- Responsible for daily operations on the production floor, including scheduling, staffing, training, material use and troubleshooting to ensure that all operations are in full compliance with applicable MBRs/FPs, SOPs, and safety guidelines.
- Develop technical expertise in area of responsibility and provide technical instruction on new/improved processes to appropriate audiences, primarily Manufacturing personnel
- Will monitor and control labor (absence, vacation and OT) and other group expenses.
- Responsible for interviewing and selecting candidates
- Provide effective leadership through:
- Assess performance and make recommendations for annual programs such as Talent Review and Year End Compensation
- Individual goal setting/performance reviews
- Ensure appropriate staffing levels and skill sets are maintained
- Effectively manage employee performance issues and corrective actions
- Ensure the use of safe work practices and behaviors
- Recognize and appreciate employee contributions and support workforce diversity
- Ensure that employees are working in a safe and compliant manner
- Ensure that staff Individual Training Record (ITR s) targets are met
- Schedule and track training attendance
- Evaluate training effectiveness
- Day to day training and coaching employees
- Issue deviations or investigations of various complexities and work with cross-functional departments to evaluate root cause, close them and implement appropriate corrective actions.
- Provide technical expertise to resolve manufacturing issues and interact with support groups to ensure production targets are met and product and process comply with cGMPs, product licenses and corporate policies.
- Ensure operational metrics and business systems (ERP, Inventory) are maintained.
- Revise, author and review Standard Operating Procedures/Batch Records
Education and Experience Requirements:
- Bachelor s of Science degree and 2-4 years related industry experience or an equivalent level of education and/or related experience is acceptable.
- Experience as a Lead or Supervisor in a GMP Manufacturing facility required
- Experience in executing moderate to complex schedules preferred
- Experience with systems such as SAP, LIMS and TrackWise is a plus
Key Skills, Abilities, and Competencies:
- Must possess effective leadership skills
- Operational knowledge of aseptic technique, clean-in-place (CIP) and steam-in-place (SIP) and general biopharmaceutical production equipment
- Knowledge of cGMP s and applicable agency regulations (such as the FDA, EMEA) to ensure inspection readiness of department.
- Good interpersonal skills and ability to work in a team environment
- Effective communication skills throughout all levels of the organization
- Proven organizational and time management skills.
- Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure.
Complexity and Problem Solving:
- Responsible for technical problem solving, operational improvements, and efficiency improvements
- Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations.
- Demonstrated application in practical root cause analysis methodologies.
- Internal and External Contacts
- Advises, consults and collaborates with cross-functional teams including but not limited to:Facilities and Engineering, Manufacturing Sciences and Operations Support, Quality, Validation, PMO Process Development and Health, Safety & Environment.
Notice to Employment / Recruitment Agents:
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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.