MSAT Scientist II (Downstream)

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.

Job Summary:

This position is responsible for being the primary technical support lead during technology transfer activities and/or process support lead for manufacturing
processes. Preferably, this person has prior experience supporting manufacturing processes and/or process transfer activities. The supervisor/manager provides direction and oversight, as this level of Process Scientist is expected to have a good grasp of the requirements of the role. The individual is a subject matter expert for several aspects of the role and it is expected that questions on tasks or issues will be raised by this individual when clarification or greater technical expertise is required. 

Key Responsibilities:

• Process Transfer and Process Support: Performs all functions associated with process transfer and/or process support, e.g. develop process understanding, perform gap analysis / FMEA, generate

• process models, author / review Process Descriptions and Batch Records, author / review change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, perform activities for lot release (assess deviations and process changes). May provide guidance on process transfer and support activities to junior members of the team

• Deviations / Problem Solving / Data Analysis: Assess major deviations including those that impact product quality. Identifies potential root causes using a systematic approach. Experience performing root cause analysis. Able to identify potential solutions. Performs or is able to understand all types of complex data analysis, such as interpreting process trends and data in the context of prior runs

• Documentation and Change assessments: Authors and reviews process descriptions, definitive formulations, batch records, raw material listings, change controls independently, and authors/reviews/modify the corresponding templates. Assesses change controls for impact of any change to the process, equipment or procedures that can affect process performance and product quality. Supports documentation preparation for regulatory purposes

• Represent MSAT: Represents MSAT on project teams and interfaces with customer technical and quality representatives. Represents MSAT on internal teams (e.g. Deviation and Run Daily Management System meetings). Participates in Customer and Regulatory Audits

• Training: Follows all training and policy guidelines established for the facility as well as all cGMP requirements. Ensures employee training profile is up to date at all times by regular monitoring of training lists (e.g. ComplianceWire, SAP Learning Portal) and completing all training in a timely fashion

• Perform other duties as assigned

Key Requirements:

• Minimum of Bachelor of Science degree required, preferred in Biotechnology area, Biological Sciences, or Chemical Engineering. Typically requires 3+ years of experience (2+ years with Masters) in process support role, process development, and/or process scale up and manufacturing

• Experience with commercial manufacturing (mammalian preferred), current Good Manufacturing Practices, US / EU regulations

• A range of experience with biotech, process development, process scale up, tech transfer and/or manufacturing

• Strong communication, technical writing, organizational and interpersonal skills

• Strong computer skills

• Knowledge/Experienced in chromatography and filtration

• Analytical and problem-solving skills; Attention to detail and high level of accuracy

• Ability to share 24/7 on-call support while process is being manufactured

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.