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.
The MSAT Scientist is an individual contributor who plays a key role in leading technical projects to support the Lonza GMP Manufacturing Site in Walkersville, MD. These projects may include tech transfer, process improvement, process validation (PPQ, Cleaning Validation/APS), and complex technical investigations. The MSAT Scientist works cross-functionally with Manufacturing, Quality, R&D, and Supply Chain to drive results.
The MSAT Scientist is a process SME in at least one fill-finish area such as bottle filling, bag filling, or vial filling with demonstrated experience performing fill line IQ/OQ/PQ including cleaning validation and APS qualification. Expertise across multiple areas is highly desirable. Additional experience in aseptic processing, packaging, lyophilization, tech transfer, and process validation is also valued.
Key Responsibilities
Perform facility fit and gap assessments including raw material assessment.
Author technical protocols/reports such as Continuous Process Verification, Process Performance Qualification, Cleaning Validation, APS, Engineering Runs, Packaging technologies assessment/evaluation, Pilot runs, and Investigations.
Lead projects across one or more pillars: tech transfer, process validation (PPQ, Cleaning Validation/APS), process improvement, packaging technologies, technical investigations, and Pilot Operations.
Support scale-up, investigations, customer requests, and tech transfer activities. Tasks may include assigning part numbers for new raw materials, preparing labels, SDS, Certificates of Test, assigning lot numbers, generating bills of materials, procuring materials, and submitting samples to QC.
Operate MSAT or Pilot Ops lab equipment following good laboratory practices such as 5S.
Manage Change Requests, Deviations/CAPAs per Lonza SOPs and Quality Systems tools, serving as SME during internal and external audits.
Identify and implement process improvements that reduce variability, streamline manufacturing, and improve efficiency.
Lead complex technical investigations and manufacturing process troubleshooting.
Perform process monitoring and statistical data analysis; prepare reports and presentations.
Train Manufacturing operators (as applicable).
Assess customer inquiries and production request forms, including batch scaling proposals and Customer Production Requests (CPRs).
Establish credibility and build strong relationships with key stakeholders and functional groups.
Key Requirements
At least 4 years of experience in fill-finish operations (bottle filling, bag filling, or vial filling; experience in multiple areas preferred).
Strong background in aseptic processing.
Proven ability in tech transfer and manufacturing support.
Compliance-minded with excellent technical writing skills.
Experience with Good Manufacturing Practice (GMP) in a regulated environment.
Experience with root cause analysis tools (e.g., Causal Branching, Fault Tree Analysis, Event and Causal Factor Charting).
Proficient in statistical and data analysis tools such as JMP, Minitab, or Statistica.
Skilled in reading and interpreting process/equipment P&IDs.
Strong analytical and problem-solving skills; able to work independently and in teams.
Demonstrated ability to influence, lead, and collaborate with stakeholders.
Hands-on, action-oriented approach with a willingness to take calculated risks.
Strong customer focus and business awareness.
We recognize that attracting, developing and retaining the best talent is key to our strategy and success as a company. As a result, we aim for flexibility in structuring competitive compensation offers to ensure that we are able to attract the best candidates. As required by law in this state, the quoted salary range for this on-site position is $83,000.00 – $133,000.00. We use broad salary ranges that reflect the competitive market for similar jobs, provide sufficient opportunity for growth as you gain experience and expand responsibilities; while also allowing for differentiation on performance based on the breadth of our ranges, most new hires will start at the company between the lower and the middle part of the applicable range. We tailor our offers within the range based on job-related factors, including organizational needs, internal equity, market data, geographic area and the selected candidate’s experience, education, industry knowledge, location, technical and/or communication skills and other factors that may prove relevant during the selection process. This range is only inclusive of base salary, and base pay is just one component of Lonza’s total compensation package for employees. Full-time employees are eligible to receive a performance-related bonus, as well as a comprehensive benefits package including medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.
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.