Biotech Manufacturing - Biotechnologist 2 (Days - B Shift) (Biotech)
Today, Lonza is a global leader in life sciences operating across three 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.
The Manufacturing Associate Level 2 is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level III associates are expected to be fully proficient in executing process recipes, 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 a significant knowledge of cGMP compliance and an in-depth understanding of process flow and be able to make decisions based on that experience. Level III Operators are able to troubleshoot routine and non-routine equipment events, initiate deviations, review batch records and logbooks.
Shift Schedule: The shift schedule is from 7am-7pm, on a rotational schedule every other week:
Week 1: M/T/F/SAT/SUN
Week 2: W/THand nights work
Shift differentials are included for weekends
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Initial 2 week training period on day shift Monday-Friday upon hire
Key Responsibilities
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 proficiency and 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. May train other associates on these tasks and theory.
Administrative tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects, technical writing (deviations, document change forms, etc.).
Attain qualification for all assigned tasks and maintain individual training plan
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.
Support Site Data Integrity Plan by actively participating in projects, by completing deliverables and by attending training.
Apply Data Integrity principles into routine tasks by following DI policies, guidelines and procedures.
Identify and communicate DI issues to management
Perform other duties as assigned.
Key Requirements
High School Diploma or Equivalent minimum; AS/BS preferred;
Preferred area of study: Science related discipline
Working experience in manufacturing; cGMP setting preferred, and/or some experience as an Associate Level I in bio-pharma industry.
Prior experience in a laboratory or academia research environment is a plus.
Proven logic and decision making abilities, critical thinking skills.
Strong written and verbal communication skills are required.
The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities. Is open to and actively seeks out feedback on their performance and translates that feedback into action.
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
