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Senior Manufacturing Scientist Manager, Cell Therapy

Lexington, Massachusetts

Overview

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Senior Manufacturing Scientist Manager, Cell Therapy

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Job ID SR0052661 Date posted 10/01/2020 Location Lexington, Massachusetts

Primary Duties

The Cell Therapy Operations team in Lexington, MA, is establishing internal capabilities to commercially manufacture programs for in-human programs to provide life changing medicines to patients. This position’s primary role is to transfer processes and provide technical input in bringing these programs to commercialization. The focus will be on becoming the primary process expert and lead new design and planning of a Manufacturing Sciences lab to support commercial manufacturing operations. In this role you will be expected to initially closely integrate with the Cell Therapy Pharmaceutical Sciences and Operations team on-site in Cambridge, MA to transfer processes to the Commercial Lexington, MA site. The final location of the incumbent will be at Lexington. You will be working with cross functional groups including GMP manufacturing, Tech Transfer, Process Analytics, Quality and Supply Chain groups, closely interacting with Development, Technical Operations to onboard new processes and instrumentation, and support robust deployment and implementation to a commercial GMP facility.

Responsibilities

  • Primary Sr. Manufacuring Sciences SME for commercial programs
  • On-site engagement with Cell Therapy Pharmaceutical sciences and Clinical Operations Teams
  • Transfer new processes into cGMP manufacturing
  • Set up design, planning of new Manufacturing Sciences lab
  • Assist in the integration and implementation of digital data enterprises, including electronic Batch Record and data systems
  • Support Process validation and author reports
  • Engage in training of operators and other teams as needed
  • Lead/support technical problem solving in manufacturing new processes, investigations and technical deviations and recommending efficiency and/or operational improvements in cooperation with other teams and functions
  • Required to make process decisions including the trouble shooting of equipment, corrective action to process deviation
  • Support execution of Life Cycle Management process activities, and define/coordinate the related Change Control Activities, and perform risk assessments
  • Promote and maintain a safe work environment

Education and Experience Requirements

  • Bachelor's degree in life science-related discipline with 5 of experience in biotech or life sciences. Master's degree or higher with 3 years of experience in biotech or life sciences
  • Preferred having 2-5 years of industry experience in Cell Therapy manufacturing, including at least 2 years hands-on experience with GMP requirements, quality assurance and technical process transfer
  • Process validation knowledge preferred
  • Advanced knowledge of Cell Therapy-related processing and analytics, including IPCs, release and safety assays highly desirable
  • Must be familiar with GMP Change Control requirements

Key Skills, Abilities, and Competencies

  • Teamwork – Ability to work well in a highly cross-functional team environment soliciting input from other function areas as required to facilitate timely decisions.
  • Provide guidance and coaching to team members.
  • Excellent oral and written Communication - Effectively communicates ideas, project goals, and results to Management and to team members. Communicates issues and/or concerns concisely with supervisor and colleagues; in a timely manner. 
  • Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information
  • Organization – Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously
  • Motivated – Self-motivated and willing to accept temporary responsibilities outside of initial job description
  • Incumbent is responsible for resolving issues and making recommendations to meet plant production plan in a compliant manner
  • Makes Decisions for the support the manufacture of high quality biopharmaceuticals to our patients
  • Promote and maintain a safe work environment

.Internal and External Contacts

  • Interacts regularly with all site support functions:
  • Manufacturing management at all sites
  • SLT members
  • Process Development
  • Manufacturing Sciences and Operations Support
  • Facilities Operations
  • Quality Assurance & Control
  • Validation
  • Engineering
  • Supply Chain
  • Health, Safety & Environment

Other Job Requirements

  • Work is may require extended periods of standing (4 hours) in GMP facility
  • Ability to work weekends when necessary

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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – 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 SR0052661

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