Laboratory Director

Stokes Pharmacy•Mount Laurel Township, NJ

6d•Hybrid

About The Position

The Laboratory Director is responsible for the overall leadership, technical direction, regulatory compliance, and operational performance of STEP Labs. This position oversees Chemistry, Microbiology and Quality Assurance (QA) laboratory operations supporting the testing of manufactured drug products, including sterile and non-sterile dosage forms. This position requires extensive experience in analytical chemistry, microbiology, analytical method development, method transfer, verification and validation. The laboratory director is responsible for identifying and implementing opportunities to bring new analytical methods and testing capabilities in-house while ensuring laboratory activities are performed in accordance with current Good Manufacturing Practices (cGMP), FDA regulations, ICH Guidelines, ISO Certifications, USP standards, approved procedures, client requirements and established quality systems. The Laboratory Director manages laboratory personnel, provides scientific and technical oversight of testing activities, supports laboratory investigations, ensures timely and accurate reporting of analytical data, and drives continuous improvement and expansion of laboratory capabilities and facilities.

Requirements

Bachelor's degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, Microbiology, Biology, Biochemistry, Biotechnology, or a related scientific discipline required.
5-10 years of experience in the pharmaceutical industry in drug substance or drug product manufacturing.
Minimum 5–7 years of progressive pharmaceutical laboratory experience, preferably within a GMP pharmaceutical manufacturer, contract testing laboratory, CDMO, CRO, or similar regulated environment.
Minimum 3–5 years of laboratory management experience with responsibility for scientific personnel and laboratory operations.
Demonstrated experience with analytical method development, transfer, verification, and validation.
Demonstrated understanding of pharmaceutical analytical chemistry and chromatographic techniques.
Strong knowledge of cGMP, GLPs, FDA, USP, ICH, GDP, Iso, DEA, and pharmaceutical data integrity requirements.
Demonstrated experience with OOS/OOT investigations, deviations, CAPA, change control, and root-cause analysis.
PC Skills and Microsoft Office Suite including Excel, Word, PowerPoint & Outlook
Must have strong organizational skills and exceptional attention to detail
Must exhibit punctuality and low absenteeism
Able to work independently and as part of a team
Able to sit, stand, squat, kneel, reach and walk for prolonged periods of time
May need to lift up to twenty-five (25) pounds on occasion
Must be able to read, write, speak and understand English fluently and have the ability to read and interpret documents such as operating and maintenance instructions and procedure manuals.
Must possess sufficient mathematical and statistical knowledge to evaluate pharmaceutical analytical data, method-validation data, trends, specifications, concentrations, dilutions, linear regression, precision, variability, and other calculations associated with analytical chemistry and microbiological testing.
Must demonstrate the ability to evaluate complex scientific, technical, quality, and regulatory issues and make sound, scientifically justified decisions.
Must be capable of independently evaluating laboratory investigations, analytical data, method performance, technical risks, regulatory requirements, and client expectations while determining appropriate actions and escalation.
Able to sit and/or stand 8-10 hours or more per day as needed
May sit, stand, stoop, bend and walk intermittently during the day; may be necessary to work extended hours as needed
Finger dexterity to operate office equipment required
Ability to lift up to twenty-five (25) pounds on occasion

Nice To Haves

Master's degree or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Microbiology, or related scientific discipline strongly preferred.
Experience with pharmaceutical microbiology and sterile product testing strongly preferred.
Experience with both sterile and non-sterile pharmaceutical dosage forms preferred.
Experience managing or interacting with contract testing laboratories and pharmaceutical clients preferred.
Experience supporting FDA inspections and client/regulatory audits preferred.

Responsibilities

Provide overall leadership and technical oversight with chemistry and microbiology laboratory operations.
Lead mentor develop and manage laboratory supervisors chemists microbiologists analysts and other laboratory personnel.
Ensure laboratory operations are performed in accordance with applicable cGMP, Good Manufacturing Practices (GDP), FDA regulations, USP requirements approved procedures, and established quality systems.
Oversee analytical and microbiological testing of raw materials Active Pharmaceutical Ingredients (APIs), and in-process samples, finished drug products and stability samples.
Lead the introduction and implementation of new analytical methods of testing capabilities within the laboratory.
Evaluate currently outsourced testing and identify opportunities to strategically bring analytical and microbiological testing capabilities in-house.
Develop, review, and approve analytical method transfer, verification, and validation protocols and reports.
Ensure analytical methods are scientifically sound, appropriately validated or verified and suitable for their intended use.
Oversee analytical method transfers from clients, external laboratories, development laboratories, and other testing organizations.
Ensure laboratory procedures and quality systems remain compliant with applicable FDA, cGMP, USP, ICH, and client requirements.
Ensure laboratory data are complete, accurate, attributable, contemporaneous, original, and maintained in accordance with established data-integrity principles.
Oversee systems governing controlled documents, training, deviations, CAPA, change control, investigations, equipment qualification, computerized systems, and laboratory records.
Lead and support FDA inspections, regulatory inspections, client audits, and internal quality audits.
Ensure observations and audit findings are appropriately investigated, corrected, and monitored through completion.
Establish and monitor laboratory Key Performance Indicators (KPIs), including testing turnaround time, on-time completion, laboratory backlog, OOS/OOT rates, investigation closure, method-transfer timelines, equipment utilization, and client commitments.
Continuously evaluate laboratory workflow to improve efficiency while maintaining scientific quality and regulatory compliance.