Senior Chemist / Laboratory Supervisor
About The Position
Reporting to the Senior Director of Quality, the Senior Chemist / Laboratory Supervisor is responsible for providing technical and operational leadership for the Quality Control Laboratory within a regulated manufacturing environment. This role oversees daily laboratory operations while driving improvements in GMP compliance, laboratory systems, analytical practices, and overall laboratory effectiveness. The position serves as the technical lead for laboratory investigations, method development, method validation, and implementation of scientifically sound laboratory controls. This role is also responsible for strengthening laboratory compliance practices, improving data integrity, standardizing laboratory processes, and supporting the development of a scalable QC laboratory operation capable of supporting OTC product manufacturing and regulatory expectations. In addition to technical responsibilities, the Senior Chemist / Laboratory Supervisor provides leadership and oversight for QC laboratory personnel, ensuring proper training, workload coordination, and execution of laboratory activities in accordance with GMP and internal quality standards.
Requirements
- Bachelor’s degree in Chemistry, Biochemistry, or related scientific discipline
- 5+ years of laboratory experience in a regulated manufacturing environment
- Strong working knowledge of GMP requirements and laboratory compliance expectations
- Experience interpreting FDA OTC Monographs and USP test methods
- Experience with analytical method development, qualification, and validation
- Experience leading laboratory investigations, root cause analysis, and corrective actions
- Experience supervising or leading laboratory personnel
- Strong understanding of laboratory instrumentation, calibration, and data integrity principles
- Strong technical writing, analytical, and organizational skills
- Ability to manage multiple priorities in a fast-paced environment
Nice To Haves
- Experience in OTC, pharmaceutical, cosmetic, or personal care manufacturing
- Experience supporting FDA inspections and regulatory audits
- Familiarity with ISO standards and laboratory quality systems
- Experience with stability programs and specification management
- Experience with ERP systems, LIMS, or electronic quality systems
- Knowledge of risk assessment and continuous improvement methodologies
Responsibilities
- Lead daily QC laboratory operations and supervise laboratory personnel
- Establish and strengthen GMP laboratory practices, controls, and documentation standards
- Develop, qualify, validate, and improve analytical test methods and laboratory procedures
- Lead laboratory investigations related to OOS, atypical results, deviations, and nonconformances
- Review laboratory data, test results, and analytical documentation for accuracy, reliability, and compliance
- Ensure proper calibration, maintenance, and qualification of laboratory equipment and instruments
- Support implementation and oversight of laboratory data integrity practices
- Develop and improve laboratory SOPs, specifications, test methods, and related documentation
- Coordinate laboratory scheduling, testing priorities, and resource planning
- Partner cross-functionally with QA, Manufacturing, R&D, and Operations to support product quality and process improvements
- Support validation activities, including method validation, equipment qualification, and stability-related activities as applicable
- Train and mentor laboratory staff on GMP requirements, laboratory techniques, and compliance expectations
- Support audit readiness activities, regulatory inspections, and internal audits
- Identify and implement continuous improvement initiatives to improve laboratory efficiency, compliance, and technical capability
- Perform additional duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Senior
