Laboratory Director

Stokes Healthcare is a privately-owned business comprised of three divisions: Stokes Pharmacy (503A pharmacy), Epicur Pharma (503B facility) and STEP labs. The these divisions operate out of separate facilities in Mount Laurel, NJ, following different regulations and are guided by different principles. Stokes Pharmacy was founded in 1975. The pharmacy formulates custom prescription medicines for both humans and animals. The business has grown from a small, hometown operation in Medford, New Jersey, to a respected pharmacy serving the entire U.S., enabled by sophisticated online ordering and overnight shipping capabilities. In 2016, Stokes Healthcare built a world-class facility (which became Epicur Pharma), as a testament to the commitment to providing the highest level of quality. Adding a unique offering to the veterinary industry, Epicur Pharma is an FDA Registered 503B Outsourcing Facility, producing drugs such as Tacrolimus Eyedrops, Buprenorphine Injection and Gabapentin tablets. Epicur follows Current Good Manufacturing Practices (cGMP) which are the same rules and regulations followed by commercial manufacturers. Epicur Pharma is proud to be a pioneer in animal drug standards, offering the largest selection of manufactured drugs that are traditionally compounded. Epicur products are distributed directly to veterinary hospitals from our manufacturing facility and offered through Stokes Pharmacy for individual patient prescriptions. STEP Labs is a GMP-compliant laboratory that delivers accurate, reliable analytical testing for manufactured pharmaceutical products. Equipped with advanced instrumentation and operated under strict regulatory standards, STEP Labs provides comprehensive services in microbiological and chemistry analysis with a focus on quality, data integrity, and timely results. Stokes Healthcare has built a reputation for unwavering quality and superb service by holding fast to the founders’ commitment to traditional craftsmanship, combined with today’s most advanced knowledge and technologies. In a field where many corporate-owned pharmacies try to compete on price, Stokes has always put safety and quality first because patients’ lives depend on it. At Stokes, we offer competitive salaries and a comprehensive benefits package that includes medical, dental and vision coverage, life insurance, Health Reimbursement Account, Flexible Spending Account, 401(K) retirement savings plan with a generous employer match, a bonus program, paid holidays, vacation and personal time, and an excellent working environment. We are conveniently located in Mount Laurel, New Jersey, just minutes from Philadelphia and the NJ shore. JOB DESCRIPTION Summary/Objective 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. $140K annually depending on expereience Essential Duties and Responsibilities include the following. Other duties may be assigned. 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. Required Education and Experience Bachelor's degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, Microbiology, Biology, Biochemistry, Biotechnology, or a related scientific discipline required. Master's degree or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Microbiology, or related scientific discipline strongly preferred. 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. 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. 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. Experience supporting FDA inspections and client/regulatory audits preferred. 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 Eligibility Qualifications It may be necessary to work extended hours as needed. Decision Making Detail Oriented Leadership Skills Problem Solving/Analysis cGMP Manufacturing Results Driven Technical Capacity Project Management Analytical Chemistry Pharmaceutical Microbiology Method Transfer cGMP Laboratory Operations Supervisory Responsibility This position has direct supervisory responsibility for the Chemistry Manager, Microbiology Manager, and Quality Assurance Manager, with overall leadership responsibility for personnel operating within the Chemistry, Microbiology, and Quality Assurance departments. The Laboratory Director is responsible for developing the laboratory management team, establishing departmental objectives, evaluating performance, ensuring appropriate staffing and technical competency, and maintaining accountability for laboratory quality, regulatory compliance, testing timelines, investigations, method implementation, and client commitments. This job operates in both office/shared office space and controlled laboratory environments. This position requires the use of standard office equipment, and frequent standing and walking. Language Skills 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. Mathematical Skills 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. Reasoning Ability 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. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 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 Position Type and Expected Hours of Work This is a full-time position. Because of the nature of the business, work schedules may vary at times. Travel No travel is expected for this position at this time however, this could change Disclaimer The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job. #J-18808-Ljbffr