BioAgilytix · 2 days ago
Scientist II - ADA/PK
Durham, NC
Full-time
Onsite
Mid, Senior Level
4+ years expBioAgilytix is a company dedicated to delivering best-in-class bioanalytical services to support new medicine breakthroughs. The Scientist II role involves leading the development and validation of Anti-drug Antibodies (ADA) and Pharmacokinetics (PK) assays, ensuring data integrity and quality in a dynamic laboratory environment.
BiotechnologyLifestyle
Responsibilities
Serve as lead scientist on assay development project
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
Qualification
Required
Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than eight (8) years' experience in a scientific laboratory environment; or
Master's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than six (6) years' experience in a scientific laboratory environment; or
PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than four (4) years' experience in a scientific laboratory environment
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
IA role: Experience with execution of PK/biomarker/ADA assays
CB role: Experience with execution of potency/NAb assays
Benefits
Medical Insurance (HDHP with HSA; PPO)
Dental Insurance
Vision Insurance
Flexible Spending Account (medical; dependent care)
Short Term Disability
Long Term Disability
Life Insurance
Paid Time Off (4 weeks per year)
Parental Leave
Paid Holidays (9 scheduled; 5 floating)
401k with Employer Match
Employee Referral Program
Company
BioAgilytix
BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development.
1001-5000 employees
H1B Sponsorship
BioAgilytix has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (8)
2023 (8)
2022 (6)
2021 (9)
2020 (4)
Funding
Current Stage
Late StageTotal Funding
unknown2016-02-22Acquired
Leadership Team
Davide Molho DVM
Chief Executive Officer
Maureen Marchek
Chief Financial Officer
Company data provided by crunchbase