MSAT Process Scientist III - Cell Therapy (Night Shift)

Lonza • Portsmouth, NH

1d • Onsite

About The Position

The MSAT Scientist III is responsible for being the primary technical support person for Cell Therapy manufacturing processes. This scientist has experience with more than three manufacturing processes and performing more than one process transfer. 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 three aspects of the role and it is expected that questions on processes, equipment, tasks or issues will be raised by this individual when clarification or greater technical expertise is required.

Requirements

• Bachelor’s degree in Biotechnology, Biological Sciences, or Chemical Engineering.
• 6-10 years of biotech experience (6-8 years for M.S. degree or up to 5 years for Ph.D.).
• 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.

Nice To Haves

• Experience with more than three manufacturing processes.
• Performing more than one process transfer.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• 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.
• Relocation assistance is available for eligible candidates and their families, if needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior