Job Title: Manufacturing Science & Technology (MS&T) Associate
Duration: 6 months
Location: Westborough, MA 01581
Description:
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.
Essential Job Responsibilities:
- 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.
Required:
- 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.
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