Senior Research Associate

Senior Research Associate, Manufacturing Science & Technology

6 Months

Marlborough, MA

Job Summary

This individual will be responsible in planning, and execution of projects to ensure timely and successful transition of products from development groups to cGMP manufacture operations. The individual will be response to assess production process robustness at sufficient scale with the appropriate level of compliance and documentation suitable for cGMP manufacture.

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.

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 Astellas 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.

Education & Qualifications

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.