Senior PK Scientist - DMPK & BE/BA Strategy Lead

NorthEast BioAnalytical Laboratories LLC; Hamden (CT); Hybride; USD 120 000 - 190 000; Plein temps

Avantages offerts par ce poste

Discretionary bonus

2 weeks paid annual vacation

401k match and healthcare

Résumé du poste

NorthEast BioAnalytical Laboratories LLC is seeking a principal investigator to lead assigned projects, supervise junior team members, and drive PK studies in preclinical and clinical programs. You will analyze DMPK, ADME, BE/BA, Tox, SAD, MAD data, optimize PK plans, sampling and dosing, and collaborate with CROs to prepare protocols and reports.

The role also supports business development and client relations while staying current with FDA/ICH guidance and SOP benchmarks.

Qualifications

• M.S. (4+ years)/Ph.D. (2+ years) in analytical chemistry, biochemistry, pharmacology, biotechnology, or related areas.
• 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.

Responsabilités

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

Formation

MS/PhD in analytical chemistry/related field

Description du poste

NorthEast BioAnalytical Laboratories LLC is seeking a principal investigator to lead assigned projects, supervise junior team members, and drive PK studies in preclinical and clinical programs. You will analyze DMPK, ADME, BE/BA, Tox, SAD, MAD data, optimize PK plans, sampling and dosing, and collaborate with CROs to prepare protocols and reports.

The role also supports business development and client relations while staying current with FDA/ICH guidance and SOP benchmarks.