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hands-on experience in cell culture is a must.
Activities will focus on optimizing manufacturing processes for cell-based products destined for various clinical applications.
This individual will be responsible in developing, scaling up, and codifying processes for existing and new cell-based products suitable for cGMP manufacture.
Essential Job Responsibilities
• Perform short and long-term stem cell culture and differentiation experiments including new method/technology evaluation and process optimization/scale up to improve GMP production efficiency.
• Able to assess underlying technical challenges and defining the best approaches to achieve suitable processes for cGMP manufacture.
• Establish process parameters and improving manufacturing efficiencies
• May perform assays such as FCM and RT-qPCR to monitor cell culture quality and stem cell differentiation efficiency.
• Ability to execute experiments and summarize results independently and write study report.
• Successfully collaborates with Process Science and Technology (PST) team members, as well as with R&D, Technical Operations and GMP Manufacturing departments to ensure smooth integrated process and product development.
• Participate in technology transfer from CMC development groups or other company sites to GMP operations including technical training to MFG personnel.
• Support manufacturing department activities including training MFG associates, supporting MBR development and review, trending key process parameters across manufacturing batches.
• Assist in lab material inventory management and equipment maintenance.
Required:
• BS or MS degree in biology, bioengineering, or related scientific field with relevant experience of 4+ years for BS, 2+ years for MS, 0-3 year for PhD in stem cell field and/or in a biotechnology or pharmaceutical industry focusing on cell therapy development.
• Proficient at small to medium scale cell culture process development with solid knowledge of cell biology, drug product/substance manufacturing.
• Excellent aseptic skills.
• Able to develop, revise, and review SOPs, protocols, batch records, cell culture process development and technical reports.
• Excellent written and verbal communication skills.
• Detail oriented with good organizational skills and documentation practices to maintain accurate records.
• Ability to work productively in a collaborative and cross functional team environment with internal and external partners across multiple scientific disciplines.
• Able to manage priorities and maintain timelines for multiple projects in a fast-pace setting.
• Ability to work effectively independently, as well as part of a team.
Preferred:
• Knowledge and direct experience with various human cell culture platforms, specially in human pluripotent stem cell culture and differentiation towards products for regenerative medicine.
• Experience in process development of cell-based products and automation solutions.
• Experience with molecular- and cell-based assays such as RT-qPCR, Flow cytometry.
• Knowledge and direct experience in technical transfer and/or GMP manufacturing process and good documentation practices a plus.
• Proficiency using Microsoft Office software (Excel, PowerPoint, Word).
• Able to work flexible hours including working in weekends.
Research Associate
33 Locke Drive Marlboro, MA 01752 US
Posted: 07/30/2024
2024-07-30
2024-09-05
Employment Type:
Contract
Job Category: Scientific
Job Number: 610216
Is job remote?: No
Country: United States
Job Description
hands-on experience in cell culture is a must.
- Work closely with other Manufacturing Science and Technology (MST) team members, conduct laboratory experiments, and tabulate results
- Perform short and long-term cell culture experiments of established process protocols
- Assist in planning and implementing the development of new processing materials, procedures, and products
- Assist in lab material inventory and lab operation
Activities will focus on optimizing manufacturing processes for cell-based products destined for various clinical applications.
This individual will be responsible in developing, scaling up, and codifying processes for existing and new cell-based products suitable for cGMP manufacture.
Essential Job Responsibilities
• Perform short and long-term stem cell culture and differentiation experiments including new method/technology evaluation and process optimization/scale up to improve GMP production efficiency.
• Able to assess underlying technical challenges and defining the best approaches to achieve suitable processes for cGMP manufacture.
• Establish process parameters and improving manufacturing efficiencies
• May perform assays such as FCM and RT-qPCR to monitor cell culture quality and stem cell differentiation efficiency.
• Ability to execute experiments and summarize results independently and write study report.
• Successfully collaborates with Process Science and Technology (PST) team members, as well as with R&D, Technical Operations and GMP Manufacturing departments to ensure smooth integrated process and product development.
• Participate in technology transfer from CMC development groups or other company sites to GMP operations including technical training to MFG personnel.
• Support manufacturing department activities including training MFG associates, supporting MBR development and review, trending key process parameters across manufacturing batches.
• Assist in lab material inventory management and equipment maintenance.
Required:
• BS or MS degree in biology, bioengineering, or related scientific field with relevant experience of 4+ years for BS, 2+ years for MS, 0-3 year for PhD in stem cell field and/or in a biotechnology or pharmaceutical industry focusing on cell therapy development.
• Proficient at small to medium scale cell culture process development with solid knowledge of cell biology, drug product/substance manufacturing.
• Excellent aseptic skills.
• Able to develop, revise, and review SOPs, protocols, batch records, cell culture process development and technical reports.
• Excellent written and verbal communication skills.
• Detail oriented with good organizational skills and documentation practices to maintain accurate records.
• Ability to work productively in a collaborative and cross functional team environment with internal and external partners across multiple scientific disciplines.
• Able to manage priorities and maintain timelines for multiple projects in a fast-pace setting.
• Ability to work effectively independently, as well as part of a team.
Preferred:
• Knowledge and direct experience with various human cell culture platforms, specially in human pluripotent stem cell culture and differentiation towards products for regenerative medicine.
• Experience in process development of cell-based products and automation solutions.
• Experience with molecular- and cell-based assays such as RT-qPCR, Flow cytometry.
• Knowledge and direct experience in technical transfer and/or GMP manufacturing process and good documentation practices a plus.
• Proficiency using Microsoft Office software (Excel, PowerPoint, Word).
• Able to work flexible hours including working in weekends.
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Ready to kickstart your career in the vibrant region around Marlborough, Massachusetts? This area boasts a perfect blend of historic charm and modern opportunities, making it an ideal place to grow both personally and professionally. From the picturesque views at Ghiloni Park to the thriving arts scene at the New England Sports Center, there's something for everyone here. Indulge in delicious seafood at the landmark restaurant, Evviva Cucina, catch a performance at the famous New Repertory Theatre, or enjoy a day out at the Solomon Pond Mall. Join us in Marlborough, where endless possibilities await – explore our job listings today and take the next step towards an exciting career in this captivating area!
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