Shire Head of Manufacturing in Milford, Massachusetts
The Head of Manufacturing has oversight and full responsibility for the planning, implementation, execution and maintenance of manufacturing operations for new and existing products and processes at Shire’s Milford, MA CGMP biomanufacturing facility including the production of Obizur, a commercially approved biologic drug treatment for Hemophilia A. This oversight entails responsibility for the efficacy, safety and quality of all material leaving the Milford Site, strict compliance with GMP and other regulatory guidelines, SOP’s, and applicable specifications, ensuring that performance standards are consistently met or exceeded. Additionally, the scope of the role responsibility includes budget management, process improvements, manufacturing policies & procedures, production schedules, regulatory submissions, internal and external audits and people management.
The Head of Manufacturing is a key member of the Milford Site Leadership Team and participates in Shire’s global manufacturing network.
Lead the Drug Substance manufacturing operation according to site supply plan, quality systems and regulatory requirements
Ensure the effective use of material, equipment, and team in producing quality products
Ensure products are provided to customers on time so that product quality, yield, operating costs, process efficiencies and documentation are met
Collaborate with Supply Chain planning to create 24/7 production schedule and ensure adherence to meet production delivery goals
Collaborate with other departments, particularly Technical Operations and Engineering to drive process improvements, investigations and analyses to ensure maximum efficiency of production processes
Identify and track metrics for monitoring manufacturing performance and regularly report results to site, division and corporate entities
Create and Track departmental annual goals in alignment with site, division and corporate goals
Prepare manufacturing budgets and forecasts
Formulate/recommend manufacturing policies, procedures, and programs, consulting with other relevant functional areas as appropriate.
Oversee Manufacturing department preparation for internal and external audits including representing the manufacturing function and managing audit responses
Drive aligned Operational Excellence methodologies throughout manufacturing operations to meet quality and efficiency targets
Develop talent and capabilities of the manufacturing teams and individual talent and ensure cultivation of right technical expertise. Develop and sustain environment of cross functional teaming and opportunities for high performing individuals to succeed.
Responsible for assuring compliances to all regulatory requirements such as but not limited to FDA, EMEA, OSHA, and EPA.
Responsible for resolving issues and making recommendations to meet site production plan in a safe, compliant, and financially sound manner. Solicits input from other functions as required to facilitate timely decisions. Acts as the point person for issues related to process and equipment.
Key Skills, Abilities and Competencies:
Must be able to collaborate with and understand the needs of customers, stakeholders, and support functions in order to work effectively and achieve alignment
Results driven and business oriented
Ability to inspire and motivate site staff through leadership and implementation of effective management tools
Ability to rapidly pivot between strategic and tactical thinking/planning and manage multiple priorities in order to achieve department and site objectives
Knowledge of Lean tools and DMAIC problem solving approaches
Excellent team management and presentation skills. Frequently communicates to senior level internal and external management through written and verbal communications
Education and Experience Requirements:
Bachelor’s degree in Biology, Chemistry, Chemical engineering or related field with a minimum of 8 to 10 years experience of biologics manufacturing in pharmaceutical, biotechnology or comparable environment.
Knowledge of cGMPs, regulatory requirements and Intermediate/DS/API processing is required.
5 to 8 years of progressive management experience leading manufacturing teams in bioprocessing manufacturing environment
Multiproduct facility and/or CMO experience preferred.
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.