Posted to MedZilla on 8/25/2019


Takeda Pharmaceuticals

US-MA, Principal Engineer SR0034824-MZ


 
 

Primary Duties

As a key member of CMSL (Commercial Manufacturing Support Laboratory), this individual will be responsible for providing technical and scientific leadership to support downstream processes of commercial productions.

The position emphasizes leading lab-based activities to design and execute studies to support process investigations, troubleshooting, process continuous improvement, tech transfer, and life-cycle management. This individual will lead or contribute as a key member of various cross-function teams, who interacts extensively with other groups and departments within Takeda, including other PDTS groups, Manufacturing, PTS, QA, QC, Engineering and RA etc.

The individual will work with a significant degree of independence, thus should have excellent problem solving abilities. The successful candidate will be involved in a wide range of complex problems, requiring the regular use of ingenuity and creativity. Applies scientific and engineering knowledge to discover and implement highly innovative solutions and designs strategy in alignment with company objectives.

Responsibilities

Job Function and Description

  • 45% Provide technical expertise and leadership in identifying opportunities/areas, planning, designing and conducting experiments, analyzing data and documenting results
  • 25% Lead or participate as cross-function team member and/or represent PDTS-CMSL in various project teams for process improvements, investigations and manufacturing tech supports
  • 10% Responsible for high quality of written memos, study proposals, research and development reports
  • 20% Provide technical expertise and leadership in trouble-shooting and root cause analysis for process discrepancies and quality investigations with extreme complex technical nature

Education and Experience Requirements

This individual will have a minimum of:

  • PhD (8+ years), MS (10+ years) or BS (12+ years) in Chemical/Biochemical Engineering or related discipline with relevant product and process development experience in the biotechnology/pharmaceutical industry. PhD engineering degree with expertise in protein separations is the preferred qualification.
  • Recognized industry expert in the field of separations, including small-scale process development and optimization, scale-up, tech transfer and manufacturing support to large scale GMP operations. Thorough knowledge of advanced scientific theories, concepts, principles, experimental techniques and industry practices and standards. Proven record of technical leadership, including the ability to motivate and influence technical rigor.
  • Proven ability to work in a fast paced environment with demonstrated capacity to juggle multiple tasks and demands

Key Skills, Abilities, and Competencies

The successful candidate must:

  • Have excellent knowledge and experience with protein purification process development and GMP manufacturing support, including protein capture and recovery, chromatography purification, filtration, and UF/DF etc.
  • Have experience in design-of-experiment (DOE) and the ability to analyze and interpret data collected.
  • Demonstrate teamwork/collaboration and the ability to communicate appropriately and effectively
  • Be customer focused, result oriented, science driven and embrace Shire s values
  • Have the attitude to proactively learn new technologies and manage changes in purification process development and improvement
  • Have experience in GMP working environments
  • This person will have been involved in purification process development or manufacturing support, have technical leadership including the ability to influence, motivate, and drive technical rigor

Complexity and Problem Solving

This individual will be expected to:

  • Lead purification process improvement, trouble-shooting and tech transfer supports. Identify and analyze complex technical problems and then find and implement solutions
  • Apply fundamental scientific and biological principles to practical technical challenges
  • Independently, plan, design and direct experimental studies to be carried out by his/her direct reports and team members while also encouraging team work and career development
  • Work closely with his/her supervisor and coworkers in managing multiple work streams and projects. Make sound and timely decisions based on project priorities. Provide expert input to departmental and senior management towards making strategic and functional decisions

Internal and External Contacts

  • Internally, this individual will represent CMSL (Commercial Manufacturing Support Laboratory) in supporting MFG as customer with close and intensive interactions with internal business partners including PTS, other PDTS groups, QA, QC, RA and Engineering within Takeda
  • Externally, this individual will interact with vendors who may supply materials or equipment both used in small-scale development lab and in large-scale MFG.

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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