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Shire Manufacturing Support Lead (Associate Director, Manufacturing) in Los Angeles, California
The individual is responsible for manufacturing support activities, which include CAPA investigations, charge control management, production scheduling and materials management. The manufacturing support lead is responsible for ensuring B5 and B8 manufacturing meet safety, quality, operating costs and production goals for the department. He or she is responsible for hiring and development of the manufacturing support team as well as maintaining current training. The manufacturing support lead must be able to lead through the team to accomplish defined key metrics assigned to the team.
Essential Duties and Responsibilities
Ensure safety and quality to meet site production goals
Drive compliance team to ensure timely closure of events with high level of effectiveness
Ensure materials are provided to manufacturing on time to meet safety, quality and production goals.
Identify/prioritize/provide resources to assist core manufacturing to meet annual operating plan and budgetary commitments.
Manage daily support activities for both B5 and B8 production through subordinates
Ensure proper training of staff.
Drive improvements in the area of responsibilities to increase productivity/efficiencies, reduce errors and operating costs.
Manage overall coaching, training, development and succession plans for team.
Interfaces with other groups, locally and globally, to ensure smooth manufacturing activities.
Adheres to all applicable procedures and policies.
Perform analytical review of data to recommend corrective actions for manufacturing.
Support plant-wide strategic plans and activities.
Ability to manage activities through subordinates.
Ability to support manufacturing to meet safety, quality, cost and production initiatives.
Ability to interpret and analyze statistical data and information.
Ability to interface with manufacturing and other support groups such as Engineering and Technical Services to drive alignment on priorities to produce effective results.
Working knowledge of world-class pharmaceutical manufacturing methods such as Lean Manufacturing, Six Sigma, cGMP and CFR guidelines.
Ability to organize and present technical issues without assistance.
Ability to understand validation packages and regulatory licenses.
Education and/or experience
- BS or equivalent with 8-10 years of experience
- 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. (only for non-exempt positions)
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’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire 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 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 is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, 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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EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire 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.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.