Sr Manufacturing Associate (Upstream/ Downstream)
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.
Our Lexington, MA facility is seeking experienced Manufacturing Associates from the Biotech, Pharmaceuticals, and Life Science industries. This could be a Manufacturing Associate 2, Manufacturing Associate 3, or Senior Manufacturing Associate depending on years of experience, areas of specialty, and any relevant educational qualifications. We are looking for any combination of experience: Downstream, Upstream (Small Scale Cell Culture), or Upstream (Large Scale Cell Culture).
These Manufacturing Associates are responsible for the manufacture of therapeutic exosomes (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.
Standard Work Week is Monday-Friday with approximately 7AM start time (may vary based on client process requirements):
Key Responsibilities:
- Set up and operate equipment including, flask cultures, rocking and single-use stirred bioreactors (SUBs), clarification/depth filtration, AKTA chromatography and TFF-based UF/DF systems
- Execute and monitor production processes and document tasks and results in paper-based process documents in accordance with good documentation procedures (GDPs), troubleshooting issues as required.
- Train other personnel on equipment operation, cGMPs, documentation, technical theory, 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.
- Administrative tasks – may leading shift exchange, meetings, sending/receiving emails, participating in projects.
- Perform other duties as assigned.
Key Requirements:
- High School Diploma or Equivalent minimum; AS/BS preferred
- Preferred area of study: Science related discipline
- Experience in biotech/life science/pharmaceuticals manufacturing. Preferred to have 24 months’ experience as a Manufacturing Associate or Manufacturing Technician in these fields.
- Upstream or Downstream manufacturing experience will be considered. Experience in both areas is ideal.
- Proven logic and decision making abilities, critical thinking skills.
- Quality Responsibility Adherence to cGMPs is required at all times during the manufacture of Active Pharmaceutical Ingredients (APIs). All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and relevant actions
- Must have the ability to comprehend process flow and identify factors which influence the process.
- Be able to read and follow defined SOPs and policies, work independently on basic manufacturing tasks, identify and communicate non-routine events, and review more complex decisions with Supervisors. Must be able to use automated process equipment and tools.
- Strong written and verbal communication skills are required.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievement 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.