Principal Scientist (Cell Based Bioassay) Domnic Lewis has been mandated to hire for Principal Scientist (Cell Based Bioassay) We are looking for a highly experienced Principal Scientist/Senior Principal Scientist to join our Analytical R&D team, focusing on the development and evaluation of biosimilars and biologics. This role offers a unique opportunity to lead critical research activities related to the design and execution of both in vivo and in vitro assays, assessing the quality, functionality, and potency of therapeutic proteins, such as monoclonal antibodies (mAbs) and hormones. Key Responsibilities : Lead and contribute to the design, development, and execution of in vivo and in vitro assays for the quality evaluation and functional assessment of therapeutic proteins. Design in vivo assays to demonstrate the mechanism of action or estimate product efficacy, in collaboration with animal testing labs. Plan and execute various in vitro assays, such as ADCC, CDC, receptor binding assays, and other cell-based assays, to evaluate functional properties of proteins. Ensure a thorough understanding of regulatory requirements for demonstrating the functional and quality aspects of mAbs, hormones, and biosimilars. Independently plan, design, and implement experiments, analyze results, draw conclusions, and compile data for reporting. Coordinate with external laboratories for outsourcing activities when necessary. Support method qualifications and method transfers to Quality Control (QC), as well as provide ongoing analytical support. Prepare and review developmental protocols and reports in compliance with ICH, USP, EP, and IP guidelines. Lead and manage a small team of scientists at mid and junior levels, providing guidance and support for their development. Oversee data reviews and trend analyses to support ongoing investigations and ensure compliance with data integrity and good documentation practices. Qualifications and Experience : For Master's candidates : 10-15 years of relevant experience. For PhD candidates : 4-8 years of relevant experience. Master's or PhD in Biotechnology, Biochemistry, or related scientific field. Extensive hands-on experience in developing and performing immunoassays and cell-based assays for therapeutic proteins. Strong understanding of regulatory frameworks and guidelines related to mAbs, hormones, and biosimilars. Required Skills : Expertise in the development and execution of in vitro assays for biosimilars and therapeutic proteins. Proficiency in MS Office for documentation, data analysis, and reporting. Excellent troubleshooting skills and the ability to solve complex analytical challenges. Strong written and verbal communication skills for effective collaboration and reporting across functions. Analytical mindset with the ability to assess data critically and draw clear conclusions. Key Competencies : Leadership skills with experience in mentoring and managing a team of scientists. Analytical thinking and problem-solving abilities to address complex research challenges. High attention to detail and a commitment to data integrity and regulatory compliance. Strong ability to work in a collaborative, cross-functional environment. Required Skills : Expertise in protein sample preparation techniques (centrifugation, concentration, extraction, etc.). Proficiency in the operation and troubleshooting of LC and CE systems. Experience with common laboratory instruments (e.g., UV-Vis Spectrometer, weighing balances). Strong analytical thinking and data evaluation skills, with a solid understanding of statistical methods. Proficiency in using MS Office tools for documentation and data analysis. Commitment to maintaining data integrity and adhering to good documentation practices. Key Competencies : Strong attention to detail and quality-focused mindset. Ability to collaborate effectively within cross-functional teams. Excellent organizational and time-management skills. Ability to independently plan and manage multiple experiments and tasks.
