Research Associate-Scientific

Schedule: M-F Normal working hours, lab based.
TOP SKILLS:
• Assay development experience preferred
• Molecular biology skills
• BS with 0 to 3 years of relevant industry experience with DNA based method design and execution.
• Good understanding of basic molecular techniques (e.g. qPCR)
• Genomic DNA and RNA extraction experience

The Research Associate will help facilitate the development of molecular methods (e.g. qPCR) that characterize vector integration of autologous and allogenic cell therapies which are currently undergoing clinical trials, including CAR T cell products. The Research Associate will be able to execute and analyze experiments with some oversight that lead to the development of robust analytical methods. The Research Associate will have the responsibility for developing highly impactful methods, including QC methods for lot release testing as well as extended characterization methods that support process development and comparability assessments. These methods will be used to further the understanding of cell therapies, support development of the manufacturing processes, and/or QC release of the drug product. The Research Associate will have hands-on experience in assay development and will be interested in projects requiring close collaboration with other groups, such as discovery research, product sciences, process development, and QC. The Research Associate will be passionate about developing Client medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of likeminded Scientists.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Education: BS in Molecular biology, Microbiology, Cell Biology, Immunology, Chemistry, Cancer Biology, or related field

QUALIFICATIONS AND EDUCATION REQUIREMENTS
• BS with 0 to 3 years of relevant industry experience with DNA based method design and execution.
• Good understanding of basic molecular techniques (e.g. qPCR)
• Genomic DNA and RNA extraction experience using both column and bead-based techniques
• Experience with analysis and interpretation of complex datasets using statistical tools such as JMP
• Experience with cell culture, primary human cells, and cryopreservation.
• Outstanding written and oral communication skills
• Work effectively in a collaborative team setting
• Ability to work in a rapidly changing environment with frequent changes in priorities

PREFERRED QUALIFICATIONS
• Automation experience
• Working knowledge of electronic laboratory notebook software
• Experience with Design of Experiment (DoEs) using JMP or equivalent statistical software
• Experienced with authoring and revising test methods, protocols, and technical reports

DUTIES AND RESPONSIBILITIES:
• DNA & RNA isolation from cellular material
• Quantification of DNA/RNA by qPCR
• Preparation of critical reagents
• Ability to execute experiments with limited guidance and supervision
• Maintain meticulous laboratory notebooks
• Help author, review and approve technical documents, including methods, protocols, reports, and SOPs
• Understand of ICH/FDA/EMEA best practices and current thinking.
• Facilitate smooth operation of the laboratory, including ordering, assisting in the cryopreservation of cellular material, sample management, etc.

WORKING CONDITIONS (US Only):
• Office and laboratory environments with a mix of natural and LED lighting with low level of background noise. Required computer and conferencing hardware are provided. 40% seated at a desk with ergonomic and sit/stand desks and 60% time in laboratory or meetings.
• Local, national, and international travel up to 25%
• This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
• This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.