About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Synthetic Molecule Process Development (SMPD) is responsible for the development of robust and cost-effective processes for the manufacture of new small molecule pharmaceuticals, along with methods for achieving and controlling high standards of purity and quality.
The successful candidate will be responsible for the process safety evaluation of chemical processes by independently planning and executing relevant experiments. He/She will lead process safety related technology transfer activities to vendors as well as independently interpret and communicate process safety results.
Additionally, the successful candidate will be responsible for maintaining SMPD's kilolab facilities to ensure the safe demonstration of the developed chemical processes ahead of technical transfer to the manufacturing organization.
How you will contribute:
- Work with process chemists and engineers to perform a thorough evaluation of all known and potential hazards for the safe scale-up of chemical processes for preparing pharmaceutical intermediates and active products in Takeda's research and manufacturing facilities.
- Prepare complex experimental protocols.
- Collect and integrate relevant process safety data (e.g., calorimetry, pressure build-up, off-gassing), using for e.g. DSC, ARC, TSU, EasyMax, RC-1 and ARC into digital platforms for seamless data analysis and sharing, ensuring data complies with FAIR principles (Findable, Accessible, Interoperable, Reusable).
- Work with external vendors to collect relevant process safety data.
- Summarize and document results in an ELN as well as generate process safety test reports.
- Conduct a HAZOP analysis and support phase appropriate process safety testing.
- Partner with internal & external manufacturing organizations to ensure the safe scale-up of Takeda's processes.
- Draft operating procedures, train SMPD staff and ensure adherence to quality standards.
- Maintain SMPD's kilolabs, ensuring that they are safe, clean and functional.
- Manage the kilolab inventory (including chemicals, reagents, equipment & consumables) and ensure adequate supplies are available.
- Coordinate with contractors, vendors, and internal stakeholders to oversee the installation, commissioning, and qualification of kilolab equipment and systems.
- Oversee internal manufacturing campaigns (e.g. review batch records, set-up equipment, support execution & cleaning).
- Support local initiatives as directed by his/her supervisor and participate in global functional initiatives as appropriate.
Minimum Requirements/Qualifications:
- Bachelor’s degree in Materials Sciences, Chemical Engineering, Mechanical Engineering with 5+ years relevant industry experience in process safety, manufacturing; chemical or pharmaceutical industry preferred.
- Master’s degree in Materials Sciences, Chemical Engineering, Mechanical Engineering with 3+ years relevant industry experience in process safety, manufacturing; chemical or pharmaceutical industry preferred.
- Previous experience working in a lab setting.
- Previous experience working in a pilot plant setting a plus.
- Previous experience in process safety in the pharmaceutical, agrochemical, fine chemical or related industry preferred.
- Previous experience with HAZOPs and/or PHAs preferred.
- Experience using relevant process safety equipment (e.g. DSC, RC1, Easymax HFCal, ARC, Tsu) preferred.
- Previous experience with software packages for process safety prediction (e.g., AKTS, Aspen Plus, gPROMS) a plus, focusing on the prediction of thermal, chemical, and kinetic properties.
- Understanding of FAIR data principles (Findable, Accessible, Interoperable, Reusable) to drive efficient data management for safety modeling and analytics.
Knowledge and Skills:
- Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information.
- Teamwork - Ability to work well in a highly cross-functional team environment.
- Communication - Able to express oneself clearly and concisely within team; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor; technical writing skills to support contributing to internal technical documents.
- Organization - Exercises good time management and prioritization skills and is able to successfully manage multiple tasks simultaneously.
- Knowledge Sharing - Ability to capture organizational knowledge; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use.
- Technical - Advanced proficiency in use of applicable lab equipment and operations.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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