Job Title: Senior Operations Project Lead - Alachua, Florida
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.
Location/Division Specific Information
As part of Thermo Fisher (Patheon) Alachua, FL Gene Therapy Site's manufacturing organization, the Senior Operations Project Lead (OPL) is responsible for Partnering with Manufacturing, Process Development, Engineering, Facilities, Quality Control, and Quality Assurance. The Senior OPL will ensure operational readiness and provide efficient and effective manufacturing production and technical support/troubleshooting for all processes and products in manufacturing. In addition, the individual is responsible for partnering across site(s) to evaluate and/or complete facility fit, author technical master batch records, drive change control and process improvement, data collection and campaign summary reports by providing expertise in equipment design, function, and process capability. The incumbent will continuously drive improvements to Safety, Quality, Delivery, Cost, and People metrics.
How will you make an impact?
The OPL is responsible for leading cross functional asset and process focused operational and/or technical assessments as part of a team ensuring consistent and reliable supply of released viral vector drug substance and/or drug product.
What will you do?
- Lead manufacturing, engineering, site services, quality units by providing expertise in equipment/process design, function, and capability
- Drives technical transfer from Process Development to Manufacturing
- Lead operational readiness for clinical manufacturing of cell/viral banks, drug substance and/or drug product by coordinating with program core teams and client representatives
- Manage investigations of process and equipment related deviations, identifies root cause as part of a cross-functional team, and drives CAPA to sustainable implementation
- Manage change control for process changes/improvements to ensure robust risk assessment and mitigation
- Provides support to manufacturing for complex problems and issues not limited to but including process/equipment
- Proactively identify and escalate key risks and issues to site leadership. Coordinate with cross-functional teams to develop risk mitigation plans
- Oversee draft and approval process for master batch records, technical guidance documents, campaign summary reports
- Establish and manage KPIs such as on-time delivery, right-first-time, yield, etc.
- Evaluates equipment and processes for Safety and Quality through Job Hazard Analysis and Failure Mode and Effects Analysis in partnership with Safety, Process Development, Technical Transfer, and Engineering personnel
- Lead and sustainably drive continuous improvement projects that increase compliance, simplify/standardize and/or gain efficiencies
- Remain current with modern process technologies and science.
- Others as assigned or needed to support operational readiness
How will you get here?
- Bachelor's degree and 7+ years of related work experience or Master's degree and 5 years of work experience
- 2+ years in management and/or leadership positions in small and medium technical and/or capital projects
- Preferred experience working in 2 or more functional areas. (Upstream, Downstream, Drug Product)
- Preferred experience with program management and customer interaction
Knowledge, Skills, Abilities
- Strong analytical and problem-solving skills; great attention to detail
- Expertise in managing small and medium technical and/or capital projects
- Knowledge of working in a regulated environment. Familiarity with cGMP manufacturing and FDA guidelines
- Strong leadership skills to oversee and organize cross-functional teams
- Outstanding planning, organization, multitasking, and strong interpersonal communication skills
- Familiarity with gene therapy vectors and knowledge of local, state and national regulations for working with biologics is a plus
- Strong verbal and written skills in English required
- Demonstrated ability in cGMP bioprocess operations
- This position will start as full-time, Mon-Fri 40-hour work week (8 am - 5 pm).
- Night and weekend work will be required as needed.
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.