Biotech Specialist

Position Overview

This is a full-time position, working 40 hours per week. The role involves collaborating with the PTCC team to develop and/or improve cell-based assays for cell product characterization and release. We are seeking an experienced Associate Scientist or Research Associate to join our Analytical Development team. The ideal candidate has a proven track record of innovation and a demonstrated skill set in process and analytical development. In addition to strong scientific skills, the successful candidate must be able to communicate effectively and work collaboratively as part of a team. This is a challenging and rewarding opportunity for someone who is passionate about making a difference in the field of biotechnology.

Key Responsibilities

• Develop analytical test method procedures in accordance with relevant guidelines from ICH, USP, and EP for cell therapy product GMP release testing and characterization.
• Support analytical routine testing, qualification, and validation.
• Evaluate reagents and supplies to meet QC standards.
• Co-author test methods (SOPs), technical reports, and analytical sampling plans.
• Document laboratory procedures and experiments with attention to detail in laboratory notebooks.
• Perform assays for process assessment and product characterization.
• Participate in assay transfers to QC and provide lifecycle support.
• Evaluate alternative technologies to create robust and reproducible analytical methods.
• Set up, monitor, sample, and analyze cell culture processes.
• Collaborate with R&D teams to enhance the understanding of analytical methods for product critical quality attributes.

Required Qualifications

• Proven track record of innovation and expertise in process and analytical development.
• Strong scientific skills with the ability to develop and improve cell-based assays.
• Excellent communication skills and the capacity to work collaboratively within a team.

Benefits & Perks

• Compensation: Highly competitive package including salary, bonus, and stock options.
• Benefits: Comprehensive benefits package including medical, dental, and vision insurance.
• Paid time off and holidays.
• Generous 401(k) matching program.