Extractables and Leachables Laboratory Manager

Clay Today; Wilmington, Northern (NC, KY); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Subsidized childcare

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC is seeking a qualified candidate to lead the extractables and leachables (E/L) laboratory. The role requires writing and executing test protocols and delivering final reports for cGMP compliance.

Five years of E/L experience is desirable. QCL offers competitive salaries commensurate with experience and an excellent benefits package, plus subsidized childcare at a 5-Star facility.

Qualifications

• Minimum 5 years of experience in extractables and leachables laboratories.
• Ability to write and execute test protocols.
• Experience generating final reports for regulatory compliance (cGMP).

Responsibilities

• Manage the extractables and leachables laboratory operations.
• Develop and execute protocols and generate final reports.
• Ensure compliance with cGMP and QA requirements.

Skills

Laboratory management

Protocol writing

Final report generation

GxP / cGMP knowledge

Job description

QUALITY CHEMICAL LABS

Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking a highly qualified candidate to manage the extractables and leachables (E/L) laboratory. The candidate must be able to write and execute protocols and generate final reports. Five years of experience in this area is desirable.

QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our 5-Star childcare facility.

Quality Chemical Laboratories (QCL) serves the biopharmaceutical industry. We provide expert and cGMP compliant scientific testing services in support of both small and large-molecule drug products, drug substances, in-process materials, and raw materials in all phases of Research, Development, and Commercialization. QCL provides formulation development and solid dose GMP manufacturing supporting early-phase clinical trials. QCL is adding sterile fill/finish and lyophilization services launching in 2024.