ABOUT THE ROLE

Precision is building an ISO/IEC 17025-accredited analytical testing laboratory serving 503B pharmaceutical outsourcing facilities, with a focus on peptide identity, purity, potency, and sterility testing. We're looking for a Lab Supervisor / Technical Manager to own the lab's technical operations and lead our

ISO/IEC 17025

accreditation build-out from the ground up. This is a foundational hire—you'll help shape the lab's quality system, method validation program, and technical team as we grow.

WHAT YOU'LL DO

Serve as the laboratory's Technical Manager under ISO/IEC 17025, with authority over method development, method validation/verification, and technical decision-making that affects the validity of test results. Supervise day-to-day laboratory operations, including HPLC and LC-MS-based identity, purity, and potency testing, plus endotoxin and sterility testing per USP <71>, <85>, and related chapters. Own instrument qualification (IQ/OQ/PQ), calibration schedules, and equipment traceability records. Develop and maintain the competence requirements, training records, and authorization documentation required under

ISO/IEC 17025

Clause 6.2 for all laboratory personnel. Lead the lab through internal audits, management review, and the on-site accreditation assessment; serve as the primary technical point of contact with the accrediting body (A2LA or ANAB). Review and authorize test reports and Certificates of Analysis prior to release. Ensure laboratory practices align with 21 CFR Parts 210/211 (cGMP), 21 CFR Part 11 (data integrity), and ICH Q2(R1) method validation standards. Supervise and mentor analytical chemists and lab technicians; manage staffing, scheduling, and performance. Support proficiency testing program participation and nonconformance/corrective action investigations.

REQUIRED QUALIFICATIONS

Master's degree in Chemistry, Biochemistry, Analytical Chemistry, or a closely related life science. Minimum of 5 years of hands-on analytical laboratory experience, including HPLC and/or LC-MS method development and validation. Direct experience working within an

ISO/IEC 17025

quality management system or a comparable regulated quality system (cGMP, GLP). Demonstrated experience with instrument qualification, calibration, and traceability documentation. Strong working knowledge of USP compendial testing methods, including <71>, <85>, <61>/<62>, <905>, and <1225>/<1226>. Prior supervisory or team-lead experience in a laboratory setting. Excellent technical writing skills for SOPs, validation protocols, and audit-ready documentation.

PREFERRED QUALIFICATIONS

Experience specifically with peptide analytical chemistry, including identity confirmation, sequence verification, and impurity/degradant profiling. Prior experience supporting or leading an

ISO/IEC 17025

accreditation process from application through on-site assessment. Familiarity with 503A/503B compounding pharmacy regulatory requirements. Experience serving as a laboratory Quality Manager or Technical Manager of record.

WORK ENVIRONMENT & PHYSICAL REQUIREMENTS

Laboratory environment requiring standing for extended periods and use of personal protective equipment. Some work will occur in a controlled/classified space, including sterility and microbial testing. Occasional evening/weekend availability during accreditation assessments or urgent testing turnarounds.

Pay:

$60,000.00 - $80,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person