Shire Manufacturing Lead - Flexbumin (Associate Director, 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 the Director of Manufacturing for Purification and is responsible for the Flexbumin bulk purification and final formulation activities within Building 8 at the Los Angeles facility. The manufacturing lead is responsible for ensuring that safety, quality, operating costs, and production goals are met for the department. He or she is responsible for hiring and development of the manufacturing team as well as maintaining current training. The manufacturing lead must be able to lead through his team to accomplish key metrics assigned to the department.
Essential Duties and Responsibilities
Ensure products are provided to customers on time so that product quality, yield, operating costs, and process efficiencies are met.
Identify/prioritize/provide resources to meet the annual operating plan and budgetary commitments
Manage the daily manufacturing operations across the department on multiple shifts through subordinates
Ensure proper training of all staff that is part of the production process
Drive improvements in the area to reduce safety risks, improve product quality, eliminate production discrepancies, and reduce operating costs
Manages overall coaching, training, development and succession plans for his or her team
Interfaces with other groups, locally and globally, to ensure the department is successful
Prepare and follow documented budget plans
Relentlessly drive a high GMP and safety operating standard that is compliant with all applicable regulatory bodies: FDA, EMA, Chinese FDA, OSHA, etc.
Adheres to all applicable procedures and policies
Perform analytical review of data to recommend and implement corrective actions to improve the area of operations
Support plant wide strategic plans and activities
Other duties as assigned
Ability to manage activities of department through subordinates
Ability to drive safety, quality, cost, and production initiatives through a large multi-shift organization
Ability to interpret and analyze statistical data and information
Ability to work in a highly automated production environment
Ability to interface with 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 a 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
- Bachelor degree in Science or Engineering required. 8-10 years of relevant experience.
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
Must be able to gown and enter manufacturing areas.
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.
May be required to work in a confined area.
Some clean room and cool/hot storage conditions.
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.
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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.