The Head of Alewife Upstream Manufacturing is responsible for 24/7 manufacturing activities related to the Cell Culture Bioreactor and Roller Bottle and Support Operations for the manufacture of Unpurified Bullk (UPB) at the Alewife Manufacturing Facility.The Head of Alewife Upstream 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 UPB
- 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 Head of Alewife Upstream 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
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 is required
- 7 to 10 years of management experience leading large team(s) in a drug substance manufacturing environment is required
- 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
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takedaâs Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, 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.
EEO is the Law – https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law â Supplement – https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy – https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Reasonable Accommodations
Shire, a wholly-owned subsidiary of Takeda, 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.
Job ID SR0044507
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