The production supervisor position is responsible for implementing and supervising all activities in the production area to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply. Focus is on optimization for the use of raw materials, equipment and personnel in producing quality products. May monitor and control labor and capital expenditures. May assist in developing budgets. Recommends manufacturing policies, procedures and programs.
Essential Duties and Responsibilities
Supervisor is expected to provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
Responsible for supervising the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities to meet customer requirements including deadlines and quality standards.
Interview, hire, coach, motivate, develop and discipline staff. Conduct annual performance reviews for all direct reports. Assist in setting performance objectives and development plans. Monitor progress.
Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.
Emphasize training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to cGMPs and EHS regulations.
Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality. Implement changes as needed based on assessments.
Perform/lead technical reviews, investigations and process improvement projects. Provide manufacturing input into integration and validation of new equipment and processes.
Resolves technical, material and cGMP problems that may impact project deadlines. Provide guidance and troubleshooting assistance as needed during a deviation in the process.
Represent the company during FDA inspections. Provide information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs.
Provide a positive and equitable working environment emphasizing the Takeda Shared Values: Respect /Responsiveness / Results.
Demonstrated interpersonal and leadership skills with ability to interface well with other departments, and lead effectively and efficiently in a team environment.
In-depth process knowledge of related manufacturing equipment and processes.
Ability to manage multiple priorities in a manufacturing plant setting.
Ability to analyze and interpret scientific, and statistical data.
Strong professional writing skills and ability to prepare technical reports.
Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
Strong assessment and troubleshooting skills.
Ability to respond to detailed inquiries, and present information to groups and senior management.
May be required to supervise multiple groups/shifts.
Overtime may be required at times.
Good computer skills.
Education and/or experience
BS degree in a scientific or engineering discipline with 3-5 years of manufacturing experience or AA degree or equivalent manufacturing experience. Plus 4-6 years supervisory related experience required.
Must be able to lift, push, pull and carry up to 25 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.
No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
Will work in a cold, wet environment
Must be able to work multiple shifts, including weekends.
Must be able to work overtime as required (APPLICABLE TO SNE only).
May be required to work in a confined area.
Some Clean Room and cool/hot storage conditions.
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.