Manufacturing Science & Technology (MS&T) Associate

• Manage routine MS&T laboratory operations, including organization, material inventory, supply ordering, equipment coordination, and maintenance of a safe, inspection-ready workspace.
• Perform mammalian and stem cell culture activities, including media preparation, cell feeding, passaging, sampling, monitoring, and documentation.
• Execute laboratory studies in accordance with approved protocols, batch records, SOPs, and study instructions.
• Support the preparation and review of protocols, batch records, worksheets, and technical reports through data compilation, record verification, and documentation management.
• Collect, analyze, and summarize study data to support process understanding, troubleshooting, and continuous improvement.
• Support commercial readiness through process readiness studies, technology transfer activities, GMP readiness initiatives, documentation updates, and cross-functional coordination.
• Adhere to quality systems and good documentation practices, ensuring records are complete, accurate, and compliant with data integrity requirements.
• Collaborate effectively with MS&T, Manufacturing, Quality, Process Development, and other cross-functional stakeholders to achieve project and operational objectives.
• Provide support across laboratory, operational, documentation, and project activities based on business priorities.
• Duties, responsibilities, and activities may change at any time with or without notice.

The Manufacturing Science & Technology (MS&T) Associate supports laboratory operations, cell culture activities, study execution, technical documentation, and commercial readiness initiatives. This role requires a hands-on, detail-oriented professional who applies strong organizational skills, sound documentation practices, and a collaborative mindset in laboratory and GMP-support environments., * BS or MS degree in biology, bioengineering, cell biology, biochemistry, biotechnology, or a related scientific field with relevant laboratory experience appropriate for an associate-level role.

• Hands-on experience with mammalian cell culture and/or stem cell culture experience.
• Good aseptic technique and ability to follow established procedures, SOPs, batch records, and study instructions accurately.
• Strong attention to detail with demonstrated commitment to accurate documentation, record management, and data integrity.
• Strong organizational skills with the ability to manage multiple priorities and meet timelines in a fast-paced laboratory environment.
• Demonstrated flexibility to support laboratory operations, study execution, documentation, and related business needs.
• Good written and verbal communication skills and ability to work effectively both independently and as part of a team.
• Ability to work onsite and support flexible schedules, including occasional weekend or holiday work, based on cell culture or business needs.
• Proficiency with Microsoft Office applications.

Preferred:

• Experience in biotechnology, pharmaceutical, cell therapy, or GMP-regulated laboratory environments.
• Direct experience with human stem cell culture, differentiation systems, and related analytical techniques (e.g., FCM, IFA, qRT-PCR).
• Working knowledge of cGMP, quality systems, data integrity, and good documentation practices.
• Experience supporting technology transfer, process characterization/qualification, or manufacturing readiness activities.