Posted to MedZilla on 9/17/2019


Takeda Pharmaceuticals

US-MA, Manufacturing Sciences, Senior Engineer II SR0039884-MZ


 
 

Primary Duties

As a key member of Manufacturing Sciences team, this individual will be responsible for providing technical and scientific leadership to support the cell culture processes of commercial manufacturing operations. Responsibilities will include monitoring of the process, containment of process failures and deviations that occur during cell culture processes, and coordination and implementation of associated corrective and preventative actions. The individual will also participate and function as the Manufacturing Sciences lead on technology transfer and process improvement teams. This individual will also provide expertise and leadership to the upstream Manufacturing Sciences group.

Job Function and Description

35% Floor Support Support ongoing operations on the manufacturing floor.

  • Attend manufacturing morning meeting. Respond and troubleshoot process issues; evaluate process data including bioreactor performance.
  • Conduct batch review.
  • Provide training to manufacturing personnel. Identify and advance continuous improvement initiatives.
  • Provide inspection support as needed. Provide weekend call-in coverage as needed.

15% Continuous Improvement Work with manufacturing staff to identify opportunities to improve the consistency and robustness of process operations.

  • Provide leadership in the development of mfg. training initiatives.

15% Provide technical expertise and leadership to the upstream Manufacturing Sciences group.

15% Process Monitoring A key part of this role will be assisting with continued development of the process monitoring capabilities for manufacturing cell culture operations.

  • This will include support of a real time multivariate process monitoring system for bioreactor operations.
  • The individual will collaborate with key subject matter experts (SMEs) from the Manufacturing Sciences team as well as cross functional groups such as Automation Engineering, Process Development, Manufacturing and the Technical Knowledge Management to assist with the further development of this real time process monitoring system.

10% Tech Transfer Support the transfer of phase I, II/III clinical processes into the existing GMP manufacturing facilities as define by Tech Transfer group

10% Quality System Support Lead consistent and well documented response to process operations events to support investigations, deviation closure as well assistance to change control/CAPA as appropriate.

Education and Experience Requirements

Essential:

  • BS in Chemical/Biochemical Engineering or Chemistry with 8 to 12 years, MS with 6 to 10 years, or Ph.D. with a minimum of 2 years of process development / manufacturing experience with mammalian cell culture of recombinant proteins .

Desired:
  • Hands-on experience with large-scale cell culture/purification manufacturing processes, preferably with commercial or licensed products.
  • A working familiarity with single use process systems, automation (local and distributed control systems), and sterile/aseptic processing in a cGMP environment. A detailed knowledge of the science and technology for the major unit operations associated with manufacturing operations to include mammalian cell culture, bioreactors, fluid transfer, filtration, chromatography, CIP/SIP, and UF/DF processes.
  • Experience with troubleshooting / problem solving and risk assessment / mitigation.
  • Demonstrated experience making science based and/or data-driven recommendations for manufacturing operations. Experience with process / technology transfers.

Key Skills, Abilities, and Competencies

  • Candidate will make complex decisions regarding product impact on a regular basis.
  • Candidate will also be required to assess the requirements of processes against the capabilities of existing equipment/facilities interacting with cross-functional team members for review and resolution.
  • Candidate must be able to work in a dynamic environment, be able to set and balance priorities, and serve as a change agent.

The candidate will:

  • Lead cell culture process improvement, trouble-shooting and tech transfer supports. Identify and analyze complex technical problems and then find and implement solutions.
  • Develop solutions to complex problems which require the regular use of ingenuity and innovation. Ensures solutions are consistent with organization objectives.
  • Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
  • Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise.
  • Contributes to the development of new concepts, techniques, and standards. Considered expert in field within the organization.
  • Work is performed without appreciable direction. Exercises considerable latitude in determining objectives and approaches to assignment.
  • Effects of decisions are long-lasting and heavily influence the future course of the organization. Errors in judgment or failure to achieve results would result in the expenditure of large amounts of company resources.
  • Serves as consultant to management and special external spokesperson for the organization on major matters pertaining to its policies, plans, and objectives.

Other Job Requirements

  • Limited project-specific travel may be required for evaluation of new equipment.
  • Periodic weekend call-in coverage.May require on-site assistance if warranted

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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