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Job ID :
61777BR
Location :
US - California - Fremont
:
Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.


How will you make an impact?

The Senior Manager of Biologics Manufacturing is responsible for leading the Biologic and Particle Manufacturing Departments tasked with manufacturing biologic materials and flow cytometry particles in a controlled and regulated environment. Reporting to the Senior Director of Operations, this position will lead and mentor Biologic Operations Scientists and Specialists as they execute existing batch records and protocols to manufacture materials in support of IVD diagnostic assays.


What will you do?

  • Provide strong leadership to Biologic and Particles Operations Scientists and Specialists
  • Assure all material produced meet quality specifications
  • Drive productivity by improving material and yields while improving equipment, processes and quality
  • Identify and drive implementation of projects to reduce scrap and technical failure
  • Coordinate scheduling to assure adequate production and inventory
  • Support change control processes by providing review and approval for changes to operating procedures
  • Ensure effectiveness and timeliness of nonconformance and CAPA investigations related to Manufacturing activities
  • Provide project updates or presentations to site leadership regarding status of key projects or programs.
  • Select, hire, train and develop Biologics Operations Staff
  • Work with cross-functional teams to drive project timelines and deadlines, ensuring escalation process and critical path are followed
  • Assure teams are aligned with operations strategy and goals
  • Continually help to improve the company culture by practice and example to the 4”I” values of Thermo Fisher Scientific – Integrity, Intensity, Innovation and Involvement


How will you get here?

  • Bachelor’s degree in a Scientific discipline; advanced degree is big plus.
  • At least 10 years of experience in Operations or Engineering roles with extensive experience in a biologic and/or purification diagnostic manufacturing environment.
  • Advanced understanding and ability adhere to established quality standards and regulatory compliance requirements for medical device or diagnostics.
  • Technical skills in manufacturing techniques, FDA & GMP compliance, process improvement and process development.
  • Extensive experience in industry-standard protein manufacturing, purification and characterization including experience sourcing, maintaining and using animal source materials and characterization techniques.
  • Experience with flow cytometry particles and test/manufacturing equipment when used in IVD assays.
  • Proven experience driving change and continual process improvement using industry standard techniques.
  • Superior organizational skills with ability to multi-task and balance complex and routine work activities.
  • Demonstrated ability to lead, direct and manage cross-functional teams, influence business partners and get results through others. High-level business acumen.
  • Advanced interpersonal and communication skills, both written and verbal, with the ability to work as a team player and team builder.
  • Excellent communication skills for group presentations and intercompany written and verbal communications.


At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.


Apply today! http://jobs.thermofisher.com


Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

*LI-KP1




Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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