MSAT Scientist (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.
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. Some of the technical projects can include tech transfer, process improvement, process validation (PPQ, cleaning Validation/APS) and complex technical investigations. The MSAT Scientist champions positive relationships with collaborators like Manufacturing, Quality, R&D and Supply Chain. The MSAT Scientist is a process SME in at least one of the following areas of expertise: Powder milling, liquid filtration, liquid mixing, Aseptic processing (fill-finish), Packaging, Lyophilization, Tech Transfer and Process Validation.
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
Responsible for tasks associated with at least one of the following pillars: tech transfer, process validation (PPQ, cleaning Validation/APS), process improvement, packaging technologies technical investigations and Pilot Operations
Complete all tasks to generate materials (including non-GMP) for scale-up, investigations, customer requests, TTs. These tasks include (but are not limited to) assign part number for new raw materials, create labels, prepare SDS, prepare Certificate of Test (COT), assign lot numbers, generate bill of materials, procure materials, submit samples to QC
Run MSAT or Pilot Ops lab equipment following good laboratory practices such as 5S
Runs Change Requests, Deviations/CAPAs following Lonza's SOPs and Quality Systems tools and acts as SME during internal and External audits
Find opportunities for process improvement such as reducing process variability, streamlining manufacturing processes, growing efficiency
Accountable for project results including planning and monitoring from initiation through completion
Lead complex technical investigations as well as MFG process troubleshooting
1Follows all training and policy guidelines established for the facility as well as all cGMP requirements
1Establish credibility and a strong relationship with the key stakeholders and functional groups
1Perform process monitoring and data analysis using applicable statistical tools performing data mining, analyzing data preparing reports and making presentations
1Train MFG operators (as applicable)
1Assess customer's inquiries and production request forms including batch scaling proposal and Customer Production Requests (CPRs)
Generate Bill of Materials and raw material specification sheet
Key Requirements:
proven ability with at least 4 years or experience in Tech Transfer, Powder milling, Packaging and Aseptic processing. Experience in Powder milling is a plus
Compliance minded excellent technical writing skills
Experience with Good Manufacturing Practice (GMP) and Manufacturing support
Experience with root cause analysis tools such as Causal Branching, Fault Tree Analysis, Event and Causal Factor Charting and Defense Analysis
Proficient in using data analysis tools such as JMP, Minitab or Statistica
Proficient in reading process/equipment P&IDs with excellent communication skills
Able to translate opportunities into workable solutions
Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment
Demonstrates strong business awareness
Leadership: ability to lead and influence team and stakeholders
Hands-on attitude to get things done and ability to take calculated risks
Strong customer focus: dedicated to providing high-quality products and services that meet all expectations
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.
