Posted to MedZilla on 2/20/2019


Takeda Pharmaceuticals

US-MA, Downstream Development Engineer II SR0032509-MZ


 
 

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Shire Human Genetic Therapies Inc., a Takeda company, for the following job opportunity:

JOB LOCATION: Lexington, MA

POSITION: Downstream Development Engineer II

POSITION DESCRIPTION: Shire Human Genetic Therapies Inc., a Takeda company, is seeking a Downstream Development Engineer II with the following duties: perform purification process development, including timely completion of small-scale experiments, scale-up, technology transfer and technical support for programs at different phases, including pre-clinical, clinical and commercial phases; conduct all aspects of downstream process unit operations primarily at bench scale, including depth filtration, chromatography, tangential flow filtration, viral inactivation and viral filtration to support process development, optimization and characterization; contribute to the evaluation of new technology/equipment that can be applied across multiple programs; participate in technology transfer of programs, including discussions of process scale, facility fit, troubleshooting of issues; document data accurately in laboratory notebooks as per established company guidelines and procedures; draft technical reports, memos, procedures, protocols and presentations; provide organizational support and cross-functional project team participation; present to department and at project team meetings; perform scale-up and technology transfer for chromatography/filtration operations and provide support for trouble shooting and facility fit assessments; design and execute studies at lab and manufacturing scale for chromatography and filtration; perform troubleshooting at lab and manufacturing scale using chromatograms, PI data historian, Delta V, batch records, LIMS and Statistica (data analysis software) and provide technical consult for deviations, CAPA s and change controls; act as a downstream Subject Matter Expert (SME) in regulatory audits and submissions (FDA, EMA etc.) and provide technical consult for process validation strategy.

REQUIREMENTS: Bachelor s degree in Chemical Engineering, Biochemical or related field or foreign academic equivalent and 2 years of related experience. Alternative requirements: Master s degree in Chemical Engineering, Biochemical or related field or foreign academic equivalent plus 0 years of experience. Will accept any level of experience in the following skills: perform scale-up and technology transfer for chromatography/filtration operations and provide support for trouble shooting and facility fit assessments; design and execute studies at lab and manufacturing scale for chromatography and filtration; perform troubleshooting at lab and manufacturing scale using chromatograms, PI data historian, Delta V, batch records, LIMS and Statistica (data analysis software) and provide technical consult for deviations, CAPA s and change controls; act as a downstream Subject Matter Expert (SME) in regulatory audits and submissions (FDA, EMA etc.) and provide technical consult for process validation strategy.

Full time. $71,500.00 - $92,600.00/year. Competitive compensation and benefits.

Qualified applicants can apply at Takeda careers page at: www.takeda.com. Please reference job #R0032509 EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Foreign Labor Certification National Processing Center, Harris Tower, 233 Peachtree Street, Suite 410, Atlanta, GA 30303.

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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