Extractables and Leachables Laboratory Manager

Vance Airscoop; Wilmington (NC); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Excellent benefits package

Career advancement potential

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC is seeking a seasoned professional to lead our extractables and leachables (E/L) laboratory. You will oversee lab operations, ensure cGMP compliance, and mentor staff.

You will write and execute protocols, generate final reports, and collaborate with QA and R&D to support drug development and manufacturing activities. Five years of E/L experience is highly desirable.

Qualifications

• Five years of experience in extractables and leachables (E/L) programs.
• Experience writing and executing laboratory protocols.
• Ability to generate final reports and support QA.

Responsibilities

• Manage the E/L laboratory operations and staffing.
• Write and execute protocols for E/L studies.
• Generate and review final reports for regulatory submissions.

Skills

E/L management

Protocol writing

Data reporting

CGMP compliance

Education

BS in chemistry or related field

Tools

Analytical instruments

HPLC/LC-MS

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.

For more information about our company and our available positions, please visit our website @www.qualitychemlabs.com

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.