NorthEast BioLab · 3 months ago
Sr. Scientist - Pharmacokinetics (PK) Studies
NorthEast BioLab is seeking a Sr. Scientist in Pharmacokinetics to lead and manage various PK studies. The role involves conducting preclinical and clinical pharmacokinetic analyses, collaborating with CROs, and ensuring compliance with regulatory practices.
Health CareLife Science
Responsibilities
Act as principal investigator, take responsibility for assigned projects, and supervise/train junior team members
Conduct preclinical and clinical pharmacokinetic (PK) Non-compartmental Analysis (NCA) independently using Pheonix WinNonlin®
Analyze, and interpret preclinical and clinical PK studies (DMPK, ADME, BE/BA, Tox, SAD, MAD, etc.) and data to optimize PK plan, sampling, and dosing
Collaborate with 3rd Party CROs / consultants to prepare PK protocols, reports and supporting documents
Prepare timely documentation and reports covering objectives, methods, analysis, and results for drug and biomarker bioanalysis in a variety of species and biological matrices (whole blood/plasma/serum, urine, tissue homogenate, etc.)
Follow Good Laboratory Practices (GLP), Company Standard Operating Procedures (SOPs), and Sponsor Study protocols
Support business development and marketing activities, foster client relationships and help onboard new clients
Stay abreast of latest PK developments, regulatory guidance (FDA, ICH), and SOP benchmarks to improve the internal PK practices
Qualification
Required
M.S. (4+ years)/Ph.D. (2+ years) in analytical chemistry, biochemistry, pharmacology, biotechnology, or related areas
Hands-on experience with toxicology studies, bioavailability & bioequivalence, biomarker testing, immunogenicity (ADA, NAb) testing
Familiarity with bioanalysis using LC-MS/MS, ELISA, MSD, Luminex, Western Blot, and Thermofisher's Watson LIMS is a huge plus
Benefits
Discretionary performance bonus at year-end
Two weeks paid annual vacation
401k match and healthcare coverage to eligible employees
Accelerated career progression with flexibility to expand role and grow into the next level
Company
NorthEast BioLab
Bioanalytical lab with 15+ years experience in GLP and clinical bioanalysis services for drug and biomarkers.
H1B Sponsorship
NorthEast BioLab 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 (3)
2024 (3)
2023 (3)
2022 (3)
2021 (2)
Funding
Current Stage
Early StageTotal Funding
unknown2025-08-06Acquired
Recent News
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