Sr. Scientist - Pharmacokinetics (PK) Studies
NorthEast BioLab
Hamden, CT
Information Technology, Analyst, Science / R&D / Research
Role
- 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
- 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
- Competitive compensation commensurate with industry experience
- 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
- Biotechnology
- Pharmaceuticals
- Outsourcing/Offshoring
- Full Time
About the company
Company website•Biotechnology Research
With over 20 years of expertise, NorthEast BioAnalytical Laboratories LLC, also known as NorthEast BioLab, specializes in providing top-notch GLP and clinical bioanalytical services. We are proud to be trusted partners to hundreds of industry sponsors and renowned investigators in the biotechnology sector.
We are an independent, full-service facility that adheres to GLP/GCLP compliance. Our FDA-audited and DEA & CT State Schedule I-IV approved facility is managed by Watson LIMS, ensuring seamless operations. Our dedicated scientists and project teams excel in assay development, optimization, troubleshooting, and full method validation on various platforms, including Ligand Binding Assays (ELISA, Meso Scale Discovery, Luminex, Western Blotting, etc.), Mass Spectrometry Liquid Chromatography (LC-MS/MS, HPLC-UV/DAD/Fluorescence, etc.), and Cell And Gene Therapy platforms (Flow Cytometry, Cell-Based Assay, qPCR and dPCR).
With our custom assay development services, we offer comprehensive solutions for pharmacokinetics analysis studies, toxicokinetic safety testing, immunogenicity assay, multiplex cytokine analysis, PD biomarker assessment, biochemical assay, mechanism of action, gene expression, copy number variation investigations, etc.
Since its establishment in 2003, our team of dedicated biologists and chemists has been committed to empowering mission-driven biotech. With our vast experience and technical expertise, we deliver exceptional preclinical study and clinical assay development services as a Contract Research Organization (CRO).
At NorthEast BioLab, we prioritize top quality and industry-leading turnaround time while offering highly competitive pricing. Our team is dedicated to helping you meet the stringent timelines of various milestones throughout your drug development life-cycle.
SPEAK TO OUR SCIENTISTS today to expedite your bioanalytical assay development, validation, and sample analysis!