"Alerted.org

Job Title: Laboratory ManagerJob Description

We are seeking a dedicated Laboratory Manager to oversee and direct daily QC laboratory operations. The successful candidate will manage a team of analysts, ensuring efficient resource utilization and adherence to timelines while upholding cGMP compliance and maintaining a state of audit readiness.

Responsibilities

+ Direct daily QC laboratory operations, including scheduling and prioritizing workflows.

+ Manage a team of 4 analysts responsible for QC release testing, stability studies, and project-based analytical work.

+ Ensure efficient resource utilization and adherence to project timelines.

+ Uphold and maintain cGMP compliance across all laboratory activities.

+ Ensure accurate documentation and data integrity in accordance with FDA and industry standards.

+ Prepare for and support internal and external audits, maintaining a state of audit readiness.

+ Lead investigations into out-of-specification (OOS) results, deviations, and analytical issues.

+ Collaborate with Quality Assurance to implement corrective and preventive actions (CAPA).

+ Drive root cause analysis and ensure timely resolution of quality events.

+ Provide technical guidance to analysts performing QC release testing and stability studies.

+ Oversee method execution and troubleshooting performed by team members.

+ Coordinate with the method development scientist for new method implementation and transfers.

+ Identify opportunities to optimize QC workflows and improve efficiency.

+ Foster a culture of quality and continuous improvement within the laboratory.

Essential Skills

+ Proficiency in HPLC, GC, GCMS, and chromatography techniques.

+ Strong root cause analysis skills.

+ Extensive experience in lab management and quality control management.

+ At least 10 years of experience in a GMP-regulated QC laboratory with 2 years in a supervisory role.

+ Strong knowledge of FDA regulations, ICH guidelines, and pharmaceutical quality systems.

+ Experience with OOS investigations, CAPA, and audit preparation.

Additional Skills & Qualifications

+ Bachelor’s or Master’s degree in Chemistry or a related field.

+ Experience with diverse drug product types, APIs, intermediates, small-molecule, compounded pharmaceuticals.

+ Pharmaceutical, development, validation, and analytical chemistry knowledge.

+ Ability to mentor and coach others with a strong empathetic leadership style.

+ Experience as a good trainer with integrity and leading by example.

Work Environment

The role is based in a new 35,000 Sq Ft facility with two laboratories: instrumentation and wet lab. The position offers a Monday to Friday flexible day shift. You will be working alongside three other chemists, with plans to hire a fourth. The company is undergoing a period of rapid growth, with new business starting in Q1 of 2026. The work environment is dynamic, with an open lab software with Agilent, and all new GC's and HPLC's. The position comes with 2 weeks of PTO and holiday pay.

Job Type & Location

This is a Contract to Hire position based out of Maryland Heights, MO.

Pay and Benefits

The pay range for this position is $48.08 - $57.69/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Maryland Heights,MO.

Application Deadline

This position is anticipated to close on Jan 1, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.