Sr. Scientist - Pharmacokinetics (PK) Studies

About the role

Act as principal investigator, take responsibility for assigned projects, and supervise/train junior team members.

Responsibilities

• 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

Qualifications

• 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

Pay

Competitive compensation commensurate with industry experience

Schedule

Full Time

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