Senior Biotechnologist(Nights) (Biotech)
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.
Check out this video about what a career at our Portsmouth NH facility could look like for you: Your Career with Lonza in Portsmouth, NH (youtube.com)
Shift Schedule: The shift schedule is 7pm-7am on a rotating schedule each week:
· Week 1: MON/TUE/FRI/SAT/SUN
· Week 2: WED/THUR
· Shift differentials are included for weekends worked
· 4 Hours of OT built into schedule bi - weekly
· Initial 4-week training period on day shift Monday-Friday for new hires
The Senior Manufacturing Associate is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Senior Associates are expected to demonstrate expertise and breadth of knowledge in executing process recipes across a variety of production activities, following written procedures (SOPs), monitoring equipment and processes, independently performing laboratory tasks, including pH, conductivity testing, product sampling, and conducting routine sanitization tasks to maintain facility and equipment and train other operators on these tasks. They are expected to demonstrate expertise and technical leadership in cGMP compliance and an in-depth understanding of process flow and be able to make decisions based on that experience. Senior Manufacturing Associates are able to troubleshoot complex and non-routine equipment events, initiate and assess deviations, review batch records and logbooks. May be asked to assume responsibilities for covering shift supervisor absences/vacations.
• Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), troubleshooting issues and review documentation as appropriate.
• Demonstrate mastery and strong understanding of suite specific production activities and laboratory tasks such as bioreactor inoculation, chromatography column operation, product sampling, etc. and the scientific theory behind the operations and microbial controls.
• Administrative tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects, demonstrate strong technical writing abilities (deviation initiations, SOP creation, etc.).
• Train other personnel on equipment operation, cGMPs, documentation, technical theory, microbial controls or other tasks. Maintain individual training plan.
• Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as required.
• Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.
• Maintain facility and equipment through routine cleaning and sanitization, support 6S programs.
• Perform other duties as assigned.
