Scientist II - ADA/PK

BioAgilytix•Durham, NC

5d•Onsite

About The Position

At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them. Join our team as a Scientist, leading the development and validation of Anti-drug Antibody (ADA) and Pharmacokinetic (PK) assays that play a vital role in bringing innovative therapies to market. We're seeking candidates with demonstrated hands-on experience using the Gyrolab platform, along with experience performing ELISA and/or MSD assays in a regulated bioanalytical laboratory. In this role, you'll thrive in a dynamic, milestone-driven environment, contributing to assay development, data generation, and the evaluation of therapeutic performance. Our commitment to data integrity and quality is unwavering, and you'll play an instrumental role in upholding these standards within a highly regulated setting.

Requirements

Demonstrated hands-on experience with the Gyrolab platform
Ability to develop immunoassays in some or all of the following immunoassay platforms: ELISA, MSD-ECL, RIA, DELFIA, HTRF, and AlphaScreen
Ability to carry out routine tasks accurately, following strict methodology to carry out analysis, preparing samples and maintaining and operating standard laboratory equipment
Must work effectively within team to meet objectives under time constraints
Ability to take direction well and multi-task
Detail oriented and highly organized
Excellent oral and written communication skills
Proficient in the use of MS Excel and Word
Demonstrated experience serving in a supervisor role and leading teams
Knowledge and application of regulatory guidance to experimental planning and design
Experience working in GxP environments and demonstrated knowledge of GxP regulations
Experience with execution of PK/biomarker/ADA assays

Responsibilities

Serve as lead scientist on assay development projects
Serve as lead scientist on validation
Present data to clients
Independently write plans and reports for validation
Responsible for prompt identification and notification of deviations
Perform assays according to GLP guidelines
Follow GLP guidelines for validation of assays
Run assays independently
Prepare worksheets independently
Analyze and interpret data
Prepare summary tables
Peer review raw data
Prepare buffers
Troubleshoot assays
Design assay runs independently
Write SOPs
Write plans/reports for sample analysis
Order and keep accurate inventories of supplies for laboratory needs and forecast future needs based on projected project needs
May serve as principal investigator on a project
May prepare and submit deviations
Manage project timelines/scheduling
Manage budget and revenue for projects
Communicate with client
Train analysts/junior scientists
Develop assay independently
Ability to assist with definition of project scope and proposal preparation (SME)
Prepare and review scientific training materials
Set up studies in LIMS system
Other duties, as assigned
Other duties as needed