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Shire Associate Director, Downstream Manufacturing in Lexington, Massachusetts
The Associate Director of Alewife Downstream Manufacturing is responsible for 24/7 manufacturing activities related to the Purification and Support Operations for the manufacture of Drug Substance at the Alewife Manufacturing Facility.
The Associate Director of Alewife Downstream Manufacturing is responsible for developing staff capabilities and will also ensure staff members meet compliance and safety standards. This position will oversee budgets, projects and scheduling to meet business needs.
Execute the manufacturing of Drug Substance
According MA Bio Ops commitments outlined in the site supply plan
According to corporate Quality polices and regulatory requirements
Deploy Manufacturing goals in line with overall Site Goals and Operating Unit agenda
Ensure scheduling is appropriate to meet S&OP plan
Own and manage Operational budget to target
Support scheduled shutdown
Deploy aligned Operational Excellence (OE) methodologies throughout manufacturing operations to meet quality and efficiency targets for MA Bio Ops Site
Develop and sustain environment of continuous improvement
Develop capabilities of staff members around Lean Six Sigma and DMAIC methodologies
Develop talent and capabilities of the Manufacturing teams and individual talent
Ensure cultivation of right technical expertise
Develop and sustain environment of cross functional teams
Develop and sustain opportunity for high performing individuals to succeed
Provide support for portfolio management.
Meet Capital budget
Sponsor high priority cross functional projects
Maintain a state of inspection readiness
- Maintain accountability for facility and process inspections
Maintain and promote a safe working environment.
The Associate Director of Alewife Downstream Manufacturing is a member of the MA Bio Ops Manufacturing Leadership Team and is accountable to participate in and contribute to appropriate cross functional governance teams. This role is also responsible for developing strategic plans that support the goals, objectives and priorities of the Alewife Manufacturing Facility.
Establish operational directives
Oversee the manufacturing area schedule to ensure market and inventory demands are met.
Monitor expenses and maintain departmental budget.
Provide technical expertise to drive resolution of manufacturing exceptions
Identify and lead continuous improvement efforts
Provide support for project portfolio management (capital projects and technology transfers)
Support interdepartmental collaboration to provide continuity between manufacturing sites
Must be responsible and accountable for delivery of functional area objectives on time and within budget.
Participate in facility and process inspections by domestic and international regulatory agencies
Ensure that all SOPs and batch records are maintained to reflect current manufacturing methods and are in conformance with product licenses
Assure that production equipment and facilities are maintained in proper working condition and in a validated mode by assuring use of Change Control procedures
Ensure timely submission and completion of all area quality documentation to meet established timelines
Ensure that all compliance commitments are completed on time and provide documented evidence to support closure of each item according to the established timeline
Conduct routine staff meetings to ensure communication and engagement
Ensure staff development plans are in place and routine development discussions are held.
Establish department goals in accordance with site objectives
Ensure Departmental Safety Training is performed and personnel attend Site Safety Meetings
Maintain and promote a safe working environment.
Maintain audit readiness
Ensure adequate training of departmental personnel in cGMP and SOPs.
Education and Experience Requirements:
Bachelor's degree in Biology, Chemistry, Chemical Engineering or related field with a minimum of 10 years relevant experience or Master's degree in Biology, Chemistry or related field with a minimum of 7 years relevant experience
7 to 10 years of management experience leading large team(s) in a drug substance manufacturing environment.
Knowledge of cGMPs, other regulatory requirements and Intermediate/DS/API processing is required.
Strong communication and interpersonal skills are essential.
Strong comprehension of value-based production improvements
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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, 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.