US-MA, Senior Engineer II_ Manufacturing Sciences SR0029977-MZ
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 for purification of recombinant proteins.
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.
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. Candidate must have working knowledge of cGMPs and statistical analysis methods.
Candidate should be experienced with writing CMC sections of regulatory filings and supporting inspections by health authorities. A familiarity with software based statistical analysis programs as well as training in quality improvement techniques, operational excellence tools and project management is a plus.
As an active participant on multiple cross-functional teams, the candidate must demonstrate teamwork and collaboration skills. The candidate must also possess the ability to communicate appropriately and effectively both in verbal and written communications. This person will have been involved in purification process development or manufacturing support, and have technical leadership including the ability to influence, motivate, and drive technical rigor.
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
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