Posted to MedZilla on 5/19/2019


Takeda Pharmaceuticals

US-CA, Manager of Manufacturing Technical Science SR0034410-MZ


 
 

This position is responsible for managing the Bulk Manufacturing Science group within the Technical Services function. The Manufacturing Sciences team provides technical support for commercial manufacturing operations for multiple recombinant protein therapeutics in order to meet plant goals for yields, capacity, and quality - specifically to ensure high process performance, capacity utilization and success rate. The primary focus of this position will be specific to drug substance manufacturing.

Specifically, the Manufacturing Sciences group is responsible for:

  • Leading process investigations and assessing product impact for all recombinant proteins produced at the site
  • Identification of optimization opportunities, evaluation of local impact and implementation of process changes
  • Provide process and equipment expertise for process fit evaluations, technology transfers, process validation, training, regulatory support, and inspection
  • Primary entry point for all process-related support requests from Manufacturing and Quality
  • Support QbD : provide input into pFMEA, process monitoring and validation strategy
  • Providing technical support during regulatory inspections

The candidate will utilize a solid understanding of theories and practices of a variety of disciplines to manage complex projects or programs within boundaries of quality, time and budget. Based on significant technical expertise, the candidate will review and approve complex design concepts and provide general direction to technical staff. It is expected that the candidate will be acknowledged outside of the business unit or division for input on programs of some magnitude. The candidate is expected to exhibit creativity and innovation in completing department tasks as well as exhibit creativity and innovation in completing divisional and cross-functional/business unit responsibilities.

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

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.