Scientist (External CRO Management) Full-time

Scientist, Bioanalytical Outsourcing

A Scientist within the Bioanalytical Outsourcing will be responsible for overseeing all bioanalysis (nonclinical and clinical) at external CROs. They will be responsible for coordination of assay development/qualification/validation efforts on various analytical platforms as well as the subsequent sample analysis and reporting efforts for each drug program. They will be responsible for communicating progress on these deliverables to the appropriate nonclinical and clinical colleagues and project teams. The successful candidate will have demonstrated technical proficiency, solid understanding of the GLPs, exhibit scientific rigor and independent thought as well as the ability to thrive in a team-oriented environment.

In this role, a typical day might include the following:

• Provide scientific and operational oversight on all aspects of bioanalytical activities conducted at Contract Research Organizations (CROs), independently and in collaboration with representative of the Bioanalytical Outsourcing Team.
• Provide scientific support to CRO efforts in design, development, and implementation of a variety of analytical methods in a regulated (GLP, GCLP) environment and ensure that these activities are in line with current regulatory guidelines
• Work with internal and external SMEs (Subject Matter Experts) to address any/all issues that may occur during assay development and/or sample analysis
• Interface with CROs to ensure on time delivery of required milestones and proactively communicate with the CRO to ensure transparency and adherence to the timelines, availability of required contracts, quotes, purchase orders etc
• Provide CRO with critical material, obtain and archive needed documentation, work with CRO to reconcile any scientific or operational concerns, manage standing review meetings, arrange vendor visits as appropriate
• Facilitate with the review of GLP and GCLP compliance status at CROs

This job might be for you if you:

• Previous experience managing external CROs- coordinating bioanalysis, assay validation etc is a plus
• Experience with novel drug candidates (gene therapies, CAR-T, mAbs, ADCs etc) is a plus
• Excellent documentation skills with attention to detail and overall data quality
• Ability to clearly and concisely communicate project goals, deliverables internally and externally
• Ability to multi-task and work under tight timelines.

To be considered for this role, you must have:

• BS/MS with 10+yrs experience in an industry setting
• Hands-on experience with regulated bioanalysis
• Hands-on experience with assay validation/qualification relevant under multiple platforms: LBA, LC/MS, PCR-based methods