Shire Director, Manufacturing Operations in Cambridge, Massachusetts
The Head of Alewife Manufacturing is responsible for 24/7 manufacturing activities related to the Cell Culture (Bioreactor, Roller Bottle) and Purification Processes and Support Operations for the manufacture of Unpurified Bullk (UPB) and Drug Substance (DS) at the Alewife Manufacturing Facility.
The Director is responsible for developing staff capabilities and will also ensure staff members meet compliance and safety standards.
The Director will oversee budgets, projects and scheduling to meet business needs.
Execute the manufacturing of UPB and DS through DS freeze
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 Director 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. The Director is also responsible for developing strategic plans that support the goals, objectives and priorities of the Alewife Manufacturing Facility.
In collaboration with the Head of MA Bio Ops Manufacturing and other members of the Leadership Team develop goals and drive and monitor performance against those goals, objectives and KPIs.
Lead the respective manufacturing organization to ensure that production targets and budgets are met, that product and processes comply with cGMPs, product licenses and corporate policies, that quality documentation is complete and on time, and regulatory inspections are managed through satisfactory completion.
Develop organizational capabilities throughout the manufacturing organization to ensure continued staff development.
Provide technical expertise for the resolution of issues in the purification areas.
Promote and maintain a safe work environment.
Education and Experience Requirements
Bachelor's degree in Biology, Chemistry, Chemical Engineering or related field with a minimum of 12 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 progressive 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
Key Skills, Abilities, and Competencies
Leads a large team consisting of biologics manufacturing from UPB thaw through DS production. Ability to inspire, develop and motivate teams through leadership and implementation of effective management tools.
Must be able to collaborate with and understand the needs of customers, stakeholders, and support functions in order to work effectively and achieve alignment.
Ability to manage and influence multiple priorities in order to achieve department and MA Bio Ops site objectives. Ability to drive operational discipline through proven OE methodologies and behaviors.
Excellent team management and presentation skills. Ability to influence partners and develop productive relationships across MA Bio Ops Site and Technical Operations. Frequently communicate to senior management through written and verbal communications.
Complexity and Problem Solving
- 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.
Internal and External Contacts
Interacts regularly with all site support functions:
MA Bio Ops leadership team
Manufacturing Sciences & Technology
Facilities & Engineering
Production Technology & Support
Materials Management & Warehousing
Environment, Health & Safety
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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 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.