Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Lead a collaborative team of Process Engineers in delivering technical excellence with a focus on timely, right-first-time, customer-centric execution. Support successful technology transfer, process optimization, and process validation activities while ensuring regulatory compliance and continuous improvement. Partner with cross-functional teams and external global clients to deliver robust manufacturing processes that meet quality standards and customer requirements. Promote innovation and operational excellence while developing the team and fostering a culture of safety, quality, and scientific rigor.

REQUIREMENTS:
• More than 8 years of experience in technology transfer, process development, or large-scale manufacturing in mammalian cell culture and/or biologics downstream bioprocessing; or equivalent skills and experience. At least 3 years in a leadership role.
• Preferred Fields of Study: Chemistry, Biochemistry, Biology, Chemical Engineering, or related scientific/technical field
• Comprehensive knowledge of cGMP regulations & applicable global regulatory requirements, including FDA and EMA requirements
• Demonstrated success leading technology transfer, process validation, and continuous improvement initiatives
• Strong project management skills and ability to oversee multiple concurrent projects
• Experience with root cause analysis, CAPA, change control, and deviation management
• Excellent verbal and written communication skills for engaging with internal teams and external clients

• Business-level proficiency in English, both written and spoken

• Demonstrated ability to build, develop and support successful technical teams
• Proficiency with statistical analysis tools and data management systems
• Strong problem-solving capabilities and analytical thinking skills
• Experience authoring and reviewing technical documentation and regulatory submissions
• Understanding of equipment qualification requirements
• Ability to manage multiple priorities effectively
• Availability to provide after-hours MSAT on-call support or on-site troubleshooting in critical cases
• Proficient with Microsoft Office suite and relevant manufacturing/quality systems