Job Title: Sr Engineer II – MS Upstream Process Science
Location: Lexington, MA
About the role:
As a member of Manufacturing Sciences team, you will provide technical and scientific leadership to support the cell culture processes of commercial manufacturing operations. You will monitor the process, containment of process failures and deviations that occur during cell culture processes including coordinating and implementing associated corrective and preventative actions. You will participate and function as the Manufacturing Sciences lead on technology transfer and process improvement teams and provide expertise and leadership to the upstream Manufacturing Sciences group. You will report to the Associate Director, Upstream Manufacturing Sciences.
How you will contribute:
- Support ongoing operations on the manufacturing floor.
- Respond and troubleshoot process issues; evaluate process data including bioreactor performance.
- Provide training to manufacturing personnel, inspection support and weekend call-in coverage.
- Help with continued development of the process monitoring capabilities for manufacturing cell culture operations. This will include support of a real time multivariate process monitoring system for bioreactor operations.
- Collaborate with subject matter experts (SMEs) from the Manufacturing Sciences team and teams such as Automation Engineering, Process Development and Manufacturing to assist with the further development of this real time process monitoring system.
- Support the transfer of phase I, II/III clinical processes into the existing GMP manufacturing facilities as defined by Tech Transfer group
- Lead well documented response to process operations events to support investigations, deviation closure as well assistance to change control/CAPA.
- Lead cell culture process improvement, trouble-shooting and tech transfer supports. Identify and analyze complex technical problems and then find and implement solutions.
- Contribute to the development of new concepts, techniques, and standards. Considered expert in field.
- Effects of decisions are long-lasting and influence the future course of the organization. Errors in judgment or failure to achieve results would result in the expenditure of large amounts of company resources.
- Be a consultant to management and special external spokesperson for us on major matters about our policies, plans, and objectives.
What you bring to Takeda:
- BS in Chemical/Biochemical Engineering or Chemistry with 8 to 12 years, MS with 6 to 10 years, or Ph.D. with 2 years of process development / manufacturing experience with mammalian cell culture of recombinant proteins
- Hands-on experience with large-scale cell culture/purification manufacturing processes with commercial or licensed products would be ideal.
- Familiarity with single use process systems, automation (local and distributed control systems), and sterile/aseptic processing in a cGMP environment.
- 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 troubleshooting / and risk assessment / mitigation.
- Demonstrated experience making science based and/or data-driven recommendations for manufacturing operations.
- Experience with process / technology transfers.
- Experience with cell culture manufacturing or process development experience, including protein capture and recovery preferably with recombinant proteins.
- Working knowledge of cGMPs
- Familiarity with software based statistical analysis programs and statistical analysis methods.
- Training in quality improvement techniques, tools and project management would be ideal
What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs and company match of charitable contributions
- Family Planning Support
- Professional training and development opportunities
- Tuition reimbursement
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
- Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
- Limited project-specific travel may be required for evaluation of new equipment.
- Periodic weekend call-in coverage. May require on-site assistance if warranted.
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.
This posting excludes Colorado applicants.
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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
USA - MA - Lexington - BIO OPSWorker Type