Senior Manufacturing Associate IV
United States, Hayward (California)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 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 (USP, DSP and EM as applicable), following written procedures (SOPs), monitoring equipment and processes, independently performing laboratory tasks, including pH, conductivity testing, product/process sampling, environmental monitoring, 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.
- The demands described below are those essential functions that an employee must be able to accomplish in order to perform this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Marginal or non-essential functions should not be listed. Please note that regular and reliable attendance is an essential function of every position and should not be listed separately below.
- Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Employee owns their own safety and the safety of others.
- Quality Responsibility Adherence to cGMPs is required at all times during the manufacture of 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
- Environmental Demands The normal working environment is: Production Floor setting, requiring PPE, gowning, safety shoes and glasses.
- Must have the ability to comprehend process flow and identify factors which influence the process. Must 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.
- High School Diploma or Equivalent minimum; AS/BS preferred area of study: Science related discipline
- Advanced years of experience in manufacturing; GMP setting preferred, and/or 24 months’ experience as an Associate Level III in bio-pharm industry.
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.