How will you make an impact?
This role will lead process engineering for an exciting new business unit focused on microbial manufacturing. Successfully manages departmental resources in order to deliver on customer commitments and expectations. Ensure process equipment deliveries, ISO-Class cleaning, and buffers & media deliveries in support of clinical and commercial GMP plasmids. Demands are met in accordance with established quality, efficiency and regulatory standards. This involves oversight of all resources including personnel, equipment, and capital. Collaborative interaction with peers both within and outside of department is necessary for success. Management and development of direct reports is also critical to this role. Demonstrated leadership inside of the department is also an expectation.
What will you do?
Strong understanding of microbial production processes and the production environment including upstream, downstream, PD, scale up and filling
Relevant technical knowledge
Strong understanding of cGMP and other regulatory requirements
Mechanical & technical ability/aptitude
Analytical problem solving skills
Good business decisions using both cost and risk analysis
Organized, Efficient, and Results oriented
Good people coaching and development skills
Good communication and presentation skills (verbal and written in English)
Basic computer including report writing and graphing
Quality and/or Financial software (SAP, NextDocs, ComplianceWire, etc) skills a plus
How will you get here?
Bachelor degree with 7-10 years industry experience (preferably in a cGMP environment) or equivalent combination of education and experience
5-10 years of proven Management experience
Demonstrated leadership skills
Able to sit, stand, walk, lift, push, pull
Able to gown per cGMP requirements and work in a gowned condition for extended periods of time in a cleanroom environment (including various temperatures and noise conditions)
Able to work with chemicals and don appropriate PPE
Able to hear, see, smell
Able to work potentially long, flexible hours and be reachable for consultation 24 hrs. per day.
Startup experience a plus
Knowledge, Skills, Abilities
Handle multiple tasks, issues, projects
Work independently and as a part of a team
Handle difficult situations with tact and diplomacy
Distill and solve issues
Build agreement via collaboration at Thermo Fisher Scientific, each one of our 70,000 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.
Thermo Fisher Scientific Inc.