Job Title: Senior Scientist - MSAT

Job Description

We are seeking a skilled Scientist for our Manufacturing Science and Technology (MSAT) team. You will be accountable for the design and execution of experimental studies in the laboratory, providing technical leadership for client products during manufacturing and development, and generating essential documentation. The role also involves data analysis to reach actionable conclusions and effective internal information transfer.

Responsibilities

• Design and execute experimental studies in the laboratory.
• Perform laboratory experiments and analytical testing for client projects.
• Prepare and schedule laboratory equipment for experiments.
• Provide technical leadership during manufacturing and development.
• Communicate directly with clients during manufacturing and development.
• Support manufacturing in identifying and resolving process issues.
• Generate experiment protocols, reports, draft batch records, and other manufacturing documentation.
• Perform manufacturing risk assessments, such as FMEA.
• Compile and analyze experimental data.
• Present experimental data internally and externally.
• Facilitate team building for effective information transfer.

Essential Skills

• 6+ years of experience in bioprocess, cell culture, validation protocols, and laboratory work.
• Experience with cell banking, GMP, MSAT, and technical research.
• Aseptic processing, Good Manufacturing Practice (GMP) knowledge.
• Strong communication skills.
• Specific process and analytical equipment proficiency within 90 days of hire.
• Subject Matter Expert (SME) in Cell Therapy manufacturing.
• 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.
• Ability to deliver projects to specific timelines and budgets.
• Experience in team-based environments and task delegation.
• Proficient in technical writing and preparation of protocols, reports, and presentations.
• Basic understanding of cell therapy or similar products.

Work Environment

• This role operates within a professional office environment of a manufacturing operations plant.
• The work environment includes standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.
• Seating arrangements include open space seating, cubicles, and office space.
• The role requires the ability to work in a team-oriented environment and with clients.
• It may require working during weekends, holidays, and as needed.
• The environment includes exposure to infectious diseases, moderate noise levels, hazardous materials, and chemicals.
• The role requires gowning, hair net, safety glasses, gloves, and foot coverings.