Posted to MedZilla on 3/23/2019


Takeda Pharmaceuticals

US-MA, Sr. Cell Bank Manufacturing Scientist SR0033244-MZ


 
 

Primary Duties

With minimal supervision this self-motivated individual will deliver leadership and excellence in manufacturing processing, technical transfer of processes and new technologies, as well as hands on operations to meet site demands for cell bank production for clinical and commercial programs in the GMP cell bank manufacturing area. A key area of responsibility will include the identification and implementation of technologies to improve efficiencies, enable new processes and implement platform processes. The successful candidate is expected to author technical documentation and justifications for new process introductions.


The individual is expected to ensure safety, aseptic operations and compliance with cGMPs are maintained at all times. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Provide support to integrate best practices, where appropriate, into manufacturing as part of the Global Cell Bank Center of Excellence. Cross functional collaboration is a must.


Expertise with mammalian cell culture and cell cryopreservation (master and working cell banks) in a cGMP manufacturing environment is highly desirable.

Responsibilities

70%: Processing

  • Responsible for hands on Cell Bank operations on the production floor and troubleshooting to ensure that all operations are in full compliance with applicable MBRs/FPs, SOPs and safety guidelines.
  • Identify, recommend/Implement process changes/improvements, efficiency gains or safety/ergonomic improvements. Enhance established processes for efficiency gains and to be in step with industry practices.
  • Provide technical instruction on new/improved processes to Manufacturing team
  • Support technology transfers by coordinating team activities and providing technical knowledge and documentation for new manufacturing processes.
  • Collaborate closely, provide hands-on support and provide input to development
  • Ensure alignment of cell bank processes between development up to manufacturing.
  • Collaborate with Materials Management to ensure raw material planning and release for timed use in manufacturing.
  • Generate proposals, protocols and reports, and present data internal meetings.
  • Act as the lead on technical issues and provide risk assessments if required.
  • Manufacturing data management and statistical analysis of data aimed at process knowledge development/ownership and resolution of investigations.
  • Contact for troubleshooting and issue resolution or escalation.
  • Execution of routine and critical operations as well as commissioning and validation activities for technology transfer and continuous improvements.
  • Ensure work is carried out in a safe manner, notifying management of safety issues and risks.
  • Responsible for transfers of processes and new technology into the Cell bank facility and other portfolio projects (e.g. Capital projects).
  • Assemble and analyze manufacturing data aimed at both long-term trending and resolution of investigations.
  • Stays current with biotechnology industry best practices
  • Collaborate and provide hands-on support and input to other departments e.g. PDTS, QC lab as required

20%: People

  • Act as a role model (Lead by Example)
  • Provide timely feedback on staff s performance
  • Act as a resource/SME for staff and improvement projects
  • Ensure the use of safe work practices and behaviors
  • Lead/Support Tier 1 board communications and Tier 2 as required and suggest CI.
  • Review and write SOPs, as needed, to support GMP manufacturing
  • Collaborate across departments at site and globally in support of the network.

10%: Quality

  • Initiate deviations or investigations and work with cross-functional departments to identify root cause or reach closure
  • Implement appropriate corrective actions
  • Complete action items for GMP investigations, audit responses and CAPA s in accordance to established timeline
  • Revise and author Standard Operating Procedures/Batch Records as required
  • Communicate any quality issues/concerns to Supervisor and QA
  • Participate in facility and process inspections by domestic and international regulatory agencies

Education and Experience Requirements
Master s of science with 4 or Bachelor s of Science degree and 6 years or PhD with 0-1 years of relevant industry experience or an equivalent level of education and/or related experience is acceptable.
Experience in Cell Banking operations is a plus.

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.


Please visit our website at takedajobs.com

 
 


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