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Takeda Pharmaceutical Company Ltd. Senior Engineer II_ Manufacturing Sciences in Cambridge, Massachusetts
As a key member of Technical Services Manufacturing Sciences team, this individual will be responsible for providing technical and scientific leadership to support the purification processes of commercial manufacturing operations. Responsibilities will include monitoring of the process and containment of process failures and deviations that occur during purification 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 downstream Manufacturing Sciences group.
Floor Support – Troubleshoot process issues; monitor and evaluate process operation data for upstream or downstream operations including but not limited to cell culture roller bottle/bioreactor and capture step operations, filtration (NF, UF/DF) unit operations, chromatography column performance/integrity and drug substance formulation/bottling.
Process Monitoring – A key part of this role will be assisting with continued development of the process monitoring capabilities for manufacturing operations for purification operations. This will include helping to work on developing a real time multivariate process monitoring system for purification operations.
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.
Tech Transfer – Support the transfer of phase I, II/III clinical processes into the existing GMP manufacturing facilities as define by Tech Transfer group
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:
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.
Key Skills and Competencies:
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.
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:
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.
Serves as consultant to management and special external spokesperson for the organization on major matters pertaining to its policies, plans, and objectives.
The candidate will work under general direction and participate in determining objectives of assignment; plan schedules and arrange own activities in accomplishing objectives to meet customer needs.
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.
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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.
Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.