Shire Value Stream Manager Lexington Downstream Ops - Buffer Prep/EM Sampling in Lexington, Massachusetts

Primary Duties

Reporting to the Manufacturing Department Head, the value stream manager is responsible for the following:

In collaboration with department heads schedule production activities to support the MA Bio Ops manufacturing schedule

Accountable to implement Safety CAPAs and quality systems such as CAPA, Change Controls and own process improvements for the department in collaboration with area management, Engineering, Technical Services and other support functions

Represent Manufacturing in key projects (e.x. capital projects, tech transfers, kaizen events, shutdown etc.). Collaborate with support functions to deliver projects accurately and within established timelines

Collaborate with support groups and area management to ensure training program is effective and efficient

Primary representative for department during audits and inspections. Accountable for implementation of regulatory commitments

Responsible to support deviation triage, investigation root cause analysis and development of CAPA plans

Support and/or lead continuous improvement projects identified through visual management system in partnership with area management

The Value Stream Manager is a member of the Department Leadership team and is accountable to participate in and contribute to appropriate cross functional teams

Responsibilities

40% Coordinate routine and non-routine suite activities related to manufacturing schedule. Support schedule governance meetings

40% Represent Manufacturing in key projects (e.x. capital projects, tech transfers, kaizen events, shutdown etc.). Collaborate with support functions to develop and deliver projects accurately and within established timelines utilizing project management tools and best practices

10% Collaborate with area management, Engineering, Technical Services and other support functions to improve manufacturing process, drive continuous improvement projects and training.

10% Provide support for Safety CAPAs and quality systems such as CAPA, Change Controls and own process improvements across shifts

Education and Experience Requirements

Bachelor's of Science degree, and 6 years industry experience or an equivalent level of education and/or related experience.

Cross-functional experience with focus on project management and execution of moderate to complex tasks

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 Takeda’s 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.

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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.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.