MSAT Senior Scientist

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.

Lonza Portsmouth, is looking for a MSAT Senior Scientist to support the MSAT Group in Portsmouth.

POSITION:                 MSAT Senior Scientist

JOB LOCATION:      101 International Drive Portsmouth, NH 03801 [and various unanticipated locations throughout the U.S.; may work from home]

DUTIES: Serve as the primary technical support person for manufacturing processes. Perform all functions associated with process transfer and process support. Develop process understanding, perform gap analysis and FMEA, and generate process models. Write and review process descriptions, batch records, planned deviations, change controls, definitive formulations, and raw material listings. Perform process monitoring including manufacturing data summary, analysis, and data presentation. Create campaign summary reports and perform activities for lot release including assessing deviations and process changes. Recommend improvements for MSAT practices and procedures. Assess all major deviations including those that impact product quality as well as post lot release deviations that may impact multiple products. Identify potential root causes using a systematic approach. Utilize Fishbone and Kepner-Tregoe. Identify potential solutions and lead multidisciplinary teams in developing and implementing solutions. Understand and interpret complex data analysis including multiple linear regression analysis, ANOVA, and multivariate analysis. Write, review, and modify the corresponding templates. Identify and create new documents that would aid in process transfers and support activities and support documentation preparation for regulatory purposes. Author and review process descriptions, definitive formulations, batch records, raw material listings, and change controls and author, review, and modify the corresponding templates. Identify and create new documents that aid in process transfer and support activities. Identify process changes and assess change controls for impact of process, equipment, and procedural changes that can affect both process performance and product quality. Support documentation preparation for regulatory purposes. Represent MSAT on project teams and interface with customer technical and quality representatives. Participate in customer and regulatory audits. Interact with site leadership on matters concerning several functional areas, divisions, and customers. Utilize experience in process development, MSAT, and process scale up and manufacturing. Support large scale manufacturing. Utilize Mammalian Manufacturing Processes and current Good Manufacturing Practices (cGMP). Demonstrate the ability to interface and communicate extensively with internal and external clients. Recommend improvements for MSAT practices and procedures. Provide guidance on process transfer and support activities to junior members on the team. Supervise one (1) MSAT Scientist I, three (3) MSAT Scientist II, one (1) MSAT Scientist III, and one (1) MSAT Associate Scientist.  

MINIMUM REQUIREMENTS: Requires a Bachelor’s degree, or foreign equivalent degree, in Biochemistry or Biomedical Engineering and two (2) years of experience in the job offered or two (2) years of experience in a related occupation developing process understanding, performing gap analysis and FMEA, and generating process models; writing and reviewing process descriptions, batch records, planned deviations, change controls, definitive formulations, and raw material listings; recommending improvements for MSAT practices and procedures; identifying and creating new documents that would aid in process transfers and support activities and supporting documentation preparation for regulatory purposes; utilizing experience in process development, MSAT, and process scale up and manufacturing; supporting large scale manufacturing; utilizing Mammalian Manufacturing Processes and current Good Manufacturing Practices (cGMP); and demonstrating the ability to interface and communicate extensively with internal and external clients.

In lieu of a Bachelor’s degree, the employer will accept an additional two (2) years of experience in a related occupation developing process understanding, performing gap analysis and FMEA, and generating process models; writing and reviewing process descriptions, batch records, planned deviations, change controls, definitive formulations, and raw material listings; recommending impro