Shire Director Manufacturing (Cell culture, Downstream Purification) in Thousand Oaks, California
Responsible for all direct manufacturing operations associated with commercial GMP production of bulk Drug Substance (DS) and final container Drug Product (DP) of purified recombinant protein(s) for worldwide distribution and sales. Responsible for a commercial chemical modification suite. Direct departments include Industrial Cell Culture, Industrial Purification, Chemical Modification, Aseptic Filling, and Final Packaging operations. Accountable for delivering quality product consistent to an annual budget, volumes, yields, and manufacturing plan. Responsible for close and consistent interaction with the Site Lead and functional groups at the facility, as well as within the Network (Bio OpU) and Corporation. Plan, organize, integrate and review staff resources with production requirements to successfully meet current and future production targets. Direct continuous improvement strategies to meet existing and planned commitments. Ensures budgets, schedules and performance requirements are met.
Essential Duties & Responsibilities
Responsible for the outgoing quality, safety and efficacy of all finished product, compliance with all applicable specifications, Standard Operating Procedures, FDA regulations (GMP’s) and New Drug Applications.
Ensures budgets, schedules, capacity, and performance requirements are met.
Improve product quality and cost and reduce customer complaints through a proactive program that includes interaction with internal and external suppliers. Utilize collected data from customers to enhance perceived product quality.
Ensure reliable operations through life cycle management of equipment, facilities, and processes.
Adheres to all environmental, health and safety SOP’s, equipment, policies and procedures, including any department specific requirements.
Propose and devise strategies for improvements through coordination with global process alignment teams and from the data gathered in manufacturing operations.
Responsible for resolving complex problems where analysis of situations or data requires an in-depth evaluation of multiple factors.
Must execute judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Regularly interacts with senior management or executive levels on matters concerning several functional areas, division, and/or customers.
Establish and maintain an environment that stresses and encourages teamwork.
May perform other duties as assigned.
Ability to manage activities of departments through subordinate managers who exercise full supervision in terms of cost, methods, and employees. Ability to interpret and analyze statistical data and financial reports, understand and resolve technical difficulties, interface with internal engineering/technical experts and external technical representatives, and manage multiple priorities in a manufacturing environment setting. Intermediate software application skills required.
Passion for Improving Lives. Must be able to put our patients at the center of everything we do.
Quest for Innovation. Must be able to operate with agility and a learning mindset so that we can accelerate breakthrough innovations.
Inspired Teams environment. Must be able to thrive in diverse high performing teams.
Engaged with the World Around Us. Must be able to embrace change and seek diverse perspectives and partnerships to benefit patients and make a positive impact on the world.
Education and/or Experience
Bachelor’s degree in a technical discipline is required. Master’s Degree or MBA preferred with 8 to 10 years of manufacturing experience required.
This role requires a minimum of 8 years leadership experience.
Strong interpersonal, problem solving, and communication skills are required.
Operational excellence skills (i.e. Six Sigma certification and lean) and supervisory skills would be considered a plus.
Normal office environment.
Will have interaction with other people.
Pace may be fast and job completion demands may be high.
Travel up to 10%.
This is a sedentary position.
Position requires the ability to gown to enter and observe the work areas on a regular basis.
Notice to Employment / Recruitment Agents:
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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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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.