Scientist, Manufacturing Sciences and Technology

Scientist, Manufacturing Sciences and Technology (MSAT)

The Scientist-Engineer, MSAT performs process and analytical experimental studies as part of a team that is effectively delivering cell therapy services to clients in accordance with defined scope of work, timelines, and budgets. This includes leading projects in assay development, qualification and validation for technology transfer of our client's novel manufacturing processes. Our goal is to support our clients in developing commercially viable cell therapy products, so that they can become accessible to all.

Essential Functions and Responsibilities

• Accountable for the design and execution of experimental studies in the laboratory, for example:
• Perform laboratory experiments for client projects
• Perform analytical testing for client projects
• Preparation and scheduling of laboratory equipment for experiments
• Provide technical leadership of client products during manufacturing and development, for example:
• Direct technical communication with clients during manufacturing and development
• Support manufacturing in identifying and resolving manufacturing process constraints
• Lead the generation of manufacturing and development documentation, for example:
• Generating experiment protocols and reports for development projects
• Generating assay qualification/validation protocols and reports
• Generating manufacturing risk assessments, such as FMEA
• Perform data analysis to reach actionable conclusions, for example:
• Compile and analyze experimental data
• Present experimental data internally and externally to clients

Qualifications

• Minimum of a Bachelor's degree in relevant life science or engineering discipline
• Minimum of 3 years' experience in aseptic cell processing, cell culture and cell analytics under the guidance of scientific protocols
• Demonstrated ability to deliver projects to specific timelines and budgets
• Experience in working effectively and delegating tasks in a team-based environment
• Demonstrated ability in technical writing and the preparation of, protocols and reports, presentations and/or other communications
• Basic understanding of the technical principles, theories and concepts of cell therapy or similar products

Competencies/Candidate Profile

Collaboration, Accountability, Adaptability, Can-do, Technical Capacity, Problem Solving, Customer-centric, Communication

Supervisory Responsibility

No supervisory responsibilities

Minimum Required Training (optional)

Aseptic processing, Good Manufacturing Practice (GMP), communication skills, specific process and analytical equipment

Working Environment

This job may require occasional evening and weekend work

Physical Requirements

N/A

Direct reports

N/A

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.