MSAT Senior Scientist - Cell Therapy

Lonza•Portsmouth, NH

1d•Onsite

About The Position

The MSAT Sr. Scientist is responsible for being the primary technical support for manufacturing processes. This person has in-depth experience with supporting manufacturing processes and/or technical transfer. The supervisor 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 key 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. What you will get: Competitive salary and comprehensive benefits package. Opportunities for career development and advancement. Supportive and collaborative team environment. Access to cutting-edge technology and tools. Commitment to employee well-being and safety. Inclusive workplace culture. Recognition and reward for your contributions. Access to our full list of global benefits: https://www.lonza.com/careers/benefits

Requirements

Bachelor’s degree in Biotechnology, Biological Sciences, or Chemical Engineering.
6+ years of biotech experience (or equivalent with advanced degrees).
Experience in commercial manufacturing and GMP regulations.
Strong communication and technical writing skills.
Proficiency in data analysis and problem-solving.
Knowledge of cell culture and process development.
Willingness to provide 24/7 on-call support during manufacturing

Responsibilities

Process Transfer and Process Support: Performs all functions associated with process transfer and/or process support. Recommend improvements for MSAT practices and procedures. May provide guidance on process transfer and support activities to junior members of the team.
Deviations / Problem Solving / Data Analysis: Assess deviations that may impact multiple products. Identifies potential Root causes using a systematic approach. Expertise in use / application of variety of problem-solving tools. Able to identify potential solutions and lead multidisciplinary teams in developing and implementing solutions. Performs and is able to understand and interpret all types of complex data analysis.
Documentation and Change assessments: Authors and reviews process documents. Able to identify and create new documents that would aid in process transfer or support activities. Identifies process changes and assess change controls for impact of process/equipment or procedural changes that can affect both 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. Regularly interacts with site leadership on matters concerning several functional areas, divisions and/or customers. Independently engages with customers at the IPT, JPT, and JTT levels to provide technical expertise and support. Manages routine and moderately complex discussions with minimal oversight, escalating significant process-related or cross-functional issues to management as needed.
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 and completing all training in a timely fashion.
Perform other duties as assigned.