JOB OVERVIEW
We are seeking Scientist, PD Analytics candidates with extensive experience in developing, optimizing, and performing a variety of molecular and cellular biology assays; with preferably some experience working in cGMP manufacturing or regulated environment and/or a good understanding of regulatory/quality requirements.
Location: Hamilton, ON Canada
JOB DUTIES
• Design and execute in vitro experiments to assess and develop novel assays, techniques and technologies to characterize cell therapy development and/or manufacturing processes.
• Identify and determine appropriate ranges of critical assay process parameters to ensure robust, repeatable and accurate results.
• Work within the analytics group to assess, design, develop, evaluate and implement technologies, processes and methods to improve understanding of therapeutic cell product candidates, intermediates, media, reagents, growth factors and other materiel critical to safety and quality of drug substance and drug product for use in patients.
• Ensure that experiments, analytical methods and data meet the requirements for the intended use of assays, which includes characterization, lot release and comparability.
• Collect and analyze data from various assays, track and trend data, and establish specifications for critical process controls.
• Author, review and approve SOPs, study protocols, reports and other scientific and quality documents.
• Qualify and subsequently validate assays for use as Quality Control tools.
• Present scientific data to colleagues in group meetings, prepare and present internal and external presentations (presentations, posters, publications), author and submit articles to peer-reviewed journals as required.
• Perform additional duties to support the safe and efficient operation of the laboratory, and other duties as assigned.
• Manage projects in conjunction with internal and external consultants and suppliers.
EDUCATION & CERTIFICATIONS
PhD in biological sciences
WORK-RELATED SKILLS & EXPERIENCE
• Biotechnology or pharmaceutical industry experience
• Highly familiar with standard testing equipment and procedures including, but not limited to cell therapy, assay development, ELISA, DNA/RNA analysis, cell-based and screening assays, sterility, mycoplasma, endotoxin, cell-counting and PCR.
• Competent in managing large datasets/databases.
• Cooperating with a larger team, must be able to solve a wide range of complex problems in creative and practical ways.
• Successful supervisor/mentor of scientific and technical staff
• A solid understanding of aseptic techniques and technologies is required.
• Demonstrated experience developing and optimizing biological and/or chemical assays is required.
• A proven ability to be highly productive and successful in a high pace work environment with excellent attention to details and meticulous bench work.
Candidates for the Scientist position will demonstrate additional knowledge of, and preferably have experience with, DOE and statistical programs for design and analysis of experiments, QbD, and assay qualification/validation. Additional experience in IND CMC, regulatory filing and clinical specimen handling is a plus.