Job Summary

The incumbent will serve as a lead Bioanalytical Chemistry Scientist in the conduct of preclinical and clinical research studies at all levels of complexity.  Responsibilities include study management, interpretation and reporting of study data and assuring the regulatory compliance of these projects as appropriate. Additional responsibilities include, serving as a subject matter expert for the development and validation of large molecule LC-MS/MS assays (eg: oligonucleotide, protein, antibody drug conjugate), as well as serving as the primary scientific contact for key clients and the on-site support of their programs. 

In this role, key responsibilities include:

• Function independently as the responsible Scientist in the direction and execution of assigned studies in compliance with regulations as they apply to the conduct of preclinical and clinical research.
• Provide scientific expertise in study conduct, design, and interpretation.
• Participate in the proposal management and bid development process, serving as a key scientific contact.
• for new business generated from established business relationships. 
• Provide technical expertise in design, interpretation, and updates of applicable standard operating procedures.
• Participate in and coordinate all phases of the study planning process with appropriate departments. 
• Design preclinical assays, generate high-quality laboratory method, protocols, amendments, reports, and develop appropriate changes to study design for assigned projects and programs.
• Review, interpret, integrate, and present data on assigned studies.
• Function independently as the point of contact for the planning and execution of sponsor interaction related to assigned studies, including proposal management and study scheduling, conduct and reporting.
• Function as a subject matter expert in large molecule LC-MS/MS assays.   Mentor technical staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and technique validation.    
• Provide technical and scientific guidance to the research staff.
• Attend scientific meetings, conferences, and training courses to enhance job and professional skills.  Present abstracts/posters at national meetings, when appropriate, to maintain a scientific presence and visibility in areas of individual expertise.
• May supervise research and/or scientific staff, as appropriate for scope of responsibilities.
• May direct activities of assigned group(s) to ensure effective performance of function.
• Ensure optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage e of opportunities, and maintain state -of-the-art practices.
• Perform all other related duties as assigned.

Key Elements

We are looking for the following qualifications for this role:

• Bachelor’s degree (B.S./B.A.) or equivalent in a scientific related discipline. Related Master’s degree (M.S./M.A.) or PhD preferred.
• Experience: 9 to 12 years related experience in the development and/or validation of large molecule LC-MS/MS assays is required (eg: oligonucleutide, protein, antibody drug conjugate, high-resolution mass spec)
• Full understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate.
• Knowledge of applicable international guidelines for all types of studies.
• Demonstrate leadership skills as they pertain to intra- and interdepartmental initiatives, Sponsor interactions, and business development.
• Effective written and verbal communication skills.
• Ability to handle multiple projects, prioritize work and meet deadlines.
• Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and with standard laboratory calculations.

The pay rate for this position is between $125,000 and $153,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.