Bioanalytical Scientist I: PK/PD & GLP Oversight

Enigma Search; South San Francisco (CA); On-site; USD 95,000 - 125,000; Full time

Job summary

Enigma Search is seeking a Scientist I, Bioanalytical to oversee the development, validation, and execution of bioanalytical assays for PK/PD across preclinical and clinical programs. The role involves managing CROs, ensuring data integrity, and contributing to regulatory submissions.

The candidate should have a bachelor’s degree in Analytical Chemistry or related field and 6+ years in pharma/biotech bioanalysis, with hands-on LC-MS/MS, ELISA, and MSD experience, operating under GLP/GCLP

Qualifications

• Bachelor's degree in Analytical Chemistry, Biochemistry, or closely related field.
• 6+ years of pharma/biotech bioanalytical oversight experience.
• Hands-on or oversight experience with GLP and GCLP.
• Experience with LC-MS/MS, ELISA, and MSD bioanalytical methods.

Responsibilities

• Oversee development, validation, and execution of bioanalytical assays for PK/PD across preclinical, nonclinical, and clinical programs.
• Manage CROs and external labs, reviewing data to ensure compliance and accuracy.
• Prepare technical summaries of bioanalytical methods for regulatory submissions and filings.
• Coordinate bioanalysis activities across development teams to meet timelines and quality standards.
• Communicate timelines and issues to leadership and cross-functional partners.

Skills

Bioanalysis oversight

LC-MS/MS

ELISA

MSD

GLP/GCLP

Data integrity

Cross-functional collaboration

Regulatory documentation

Education

Bachelor's degree in Analytical Chemistry / related field

Tools

LC-MS/MS instrumentation

ELISA platforms

MSD instruments

Job description

Enigma Search is seeking a Scientist I, Bioanalytical to oversee the development, validation, and execution of bioanalytical assays for PK/PD across preclinical and clinical programs. The role involves managing CROs, ensuring data integrity, and contributing to regulatory submissions.

The candidate should have a bachelor’s degree in Analytical Chemistry or related field and 6+ years in pharma/biotech bioanalysis, with hands-on LC-MS/MS, ELISA, and MSD experience, operating under GLP/GCLP