Posted to MedZilla on 5/19/2019


Takeda Pharmaceuticals

US-MA, Senior Cell Bank Technical Operations Scientist SR0032752-MZ


 
 

Primary Duties

With minimal supervision this self-motivated individual will deliver leadership and excellence in

manufacturing processing, leading/or supporting technical transfer of projects to meet GMP Cell Bank

production for clinical and commercial programs. A key area of responsibility will include the identification

and implementation of technologies to ensure alignment of cell culture processes from Development to

Cell Banking to Biologics Manufacturing and ensuring execution of method transfers related to cell banking

across the global network. The incumbent will also have responsibilities in supporting site selection and

interacting with External Site Operations group for management of external CMO cell banking projects.

The successful candidate is expected to author technical documentation and justifications for new process

introductions.

The individual is expected to 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

Network. 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

Lead or support technology transfers by coordinating team activities and providing schedules, technical knowledge and documentation for new manufacturing processes and other portfolio projects (e.g. Capital projects).

Design/conduct laboratory studies aimed at Cell Bank method transfer support for storage stability studies, and other laboratory studies aimed at increasing cell culture process knowledge and improving process robustness

Identify, recommend/Implement process changes/improvements, efficiency gains or safety/ergonomic improvements. Enhance established processes and to be in step with industry practices.

Identification and implementation of technologies to ensure alignment of cell culture processes from Development to Cell Banking to Biologics Manufacturing.

Assemble and analyze manufacturing data aimed at both long-term trending and resolution of investigations. Collaborate closely, provide hands-on support as necessary and provide input to other departments e.g. manufacturing, PDTS, QC lab as required.

Support Change Control activities 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 on-the-floor technical issues and provide risk assessments if required.

Contact for troubleshooting and issue resolution or escalation.

Ensure work is carried out in a safe manner, notifying management of safety issues and risks. Stays current with biotechnology industry best practices.

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 Continuous Improvements

Review and write SOPs, as needed, to support GMP manufacturing

Collaborate across departments at site and globally in support of network Cell Banking.

10% Quality

Provide documentation for proposals, protocols, reports and risk assessments

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

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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