Shire Supervisor, Manufacturing in Los Angeles, California

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, Ophthalmic, 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.

This position reports to Grave (3) shift. This shift schedule is Monday to Friday 10:00 PM to 6:30 AM. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.

The Purification Building 8 Supervisor is responsible for implementing and supervising daily activities in Building 8 to ensure manufacturing goals and project deadlines are met by the commitment date while maintaining compliance with the current manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply. He/she is expected to drive results to support plant strategic imperatives. He/she must enforce company rules and regulations and promote Shire Values within his/her shift. He/she is expected to coach/mentor employees to drive performance. He/she must be able to prepare and present technical reports and trends. He/she must have the ability to manage multiple priorities in a manufacturing plant setting, and prioritize responsibilities of self and direct reports appropriately. He/she must have organizational and administrative skills. He/she is expected to set the example for all other employees of Shire. The direct reports of supervisors observe the behavior of their leadership and interpret that behavior as acceptable. Supervisors must promote the appropriate behavior, compliance, cleanliness, and culture of Shire.

Essential Duties and Responsibilities

  • Supervise the daily manufacturing operations in B8 Manufacturing – maintain (audit, refine, improve) equipment and processes within this area.

  • Provide a positive and equitable working environment emphasizing the Shire Leadership Behaviors – Be Positive, Accountable, Results-Driven and Excellent Manager of Self and Others.

  • Support and Emphasize the Safety and Quality commitments of the department – make decisions concerning these commitments within the area.

  • Ability to utilize resources and raw materials in the most efficient and productive manner possible.

  • Identify/prioritize/provide resources in an area to assist the superintendent to meet the annual operational plan and budgetary commitments.

  • Facilitate and verify appropriate training for employees in the area (including but not limited to GMP, job skills, safety).

  • Ensure compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements as required.

  • Commit to employee feedback and developmental process – support Talent Management goals, conduct recognition and disciplinary action for employees, facilitate employee representation throughout the organization.

  • Submit and/or maintain and distribute reports related to attendance, labor, efficiency, safety, scrap and others as needed.

  • Ability to utilize resources and raw materials in the most efficient and productive manner possible.

  • Provide leadership to assess and provide guidance and risk assessments regarding requirements for the design of the manufacturing and pilot plant facilities.

  • Create and Update Manufacturing Standard Operating Procedures.

  • May supervise more than one group.

Qualifications

  • Experience in pharmaceutical manufacturing, specifically Plasma fractionation and purification and design, installation and commissioning for projects.

  • Experience implementing Lean Manufacturing concepts.

  • Expertise in Batch Processing.

  • Experience in CIP and scheduling of Process Operations would be a plus

  • Successful track record of managing wide-ranging activities within the business unit.

  • Demonstrates leadership skills.

  • Recognized as a technical expert by peers and other personnel within the business unit.

  • Extensive cross-functional team experience, including technical and non-technical work.

  • Ability to organize and present technical and project mgt. overviews without assistance.

  • Demonstrated interpersonal and leadership skills with ability to interface well with other departments, and lead effectively and efficiently in a team environment.

  • Interact with all levels of personnel to analyze and solve problems related to manufacturing, Quality, documentation, and personnel issues.)

  • Ability to manage multiple priorities in a manufacturing plant setting.

  • Ability to understand GMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.

  • Strong assessment and troubleshooting skills.

  • Good computer skills.

  • Collect and analyze data and information to determine paths for process improvement and potential root cause/corrective actions in the case of exceptions.

  • Ability to respond to detailed inquiries, and present information to groups and senior management.

Education and/or experience

  • B.S. Degree in Science or Engineering with minimum of 1 year related manufacturing/work experience.

  • Previous leadership experience strongly preferred.

Physical Demands

  • 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.

Working Environment

  • 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 work environment.

  • Will work in a cold, wet environment with climbing to access platforms and/or equipment.

  • Will be working in a loud area that requires hearing protection and other protective equipment to be worn.

  • Will work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.

  • May be required to work or be assigned to a different shift as needed.

  • May be required to work in a confined area.

  • Inside working conditions.

  • Some Clean Room and cool/hot storage conditions.

  • 0-5% travel

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, 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/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

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.