Chemistry Analyst I

Epicur; Mount Laurel Township (NJ); On-site; USD 28,000 - 40,000; Full time

Job summary

Stokes Healthcare, a private group with Epicur Pharma and STEP Labs, is seeking a qualified analytical chemist to support cGMP testing and method transfer in its Mount Laurel, NJ laboratory. The role focuses on routine testing, stability studies and data review within a regulated environment.

The ideal candidate holds a Bachelors in Chemistry, with 3–10 years' HPLC/UPLC experience (Empower 3 preferred) and a strong eye for detail.

Qualifications

• Bachelor's degree in Chemistry or related field.
• 3–10 years of experience with HPLC/UPLC analysis, preferably using Empower 3 software.
• Familiar with GMPs, FDA, ICH and OSHA requirements.

Responsibilities

• Perform analytical testing of Finished Product, R&D Materials; Stability Samples; Raw Materials.
• Ensure testing is conducted per cGMP, USP, ICH, FDA and company standards.
• Review and approve analytical testing data; assist investigations; maintain laboratory organization and inventory.

Skills

Analytical chemistry

Attention to detail

Punctuality

Education

Bachelors Degree in Chemistry

Tools

HPLC/UPLC

Empower 3

Karl Fischer

pH meter

Job description

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 Summary

Supports cGMP analytical chemistry analysis associated with processes related to routine testing, stability testing and method transfer.

Starting at $25/hour plus twice a year bonuses.

Essential Duties and Responsibilitiesinclude the following. Other duties may be assigned.

• Independently performs analytical testing of
  • Finished Product
  • Research and Development Materials
• Stability Samples
• Raw Materials
• Ensure testing is performed in accordance with cGMP, USP, ICH, FDA and company standards
• Review and approve analytical testing data
• Assist investigations
• Authors/revises SOPs, protocols and data reports
• Maintains laboratory organization and inventory
• Assists qualification and calibration of equipment

Regulatory Responsibilitiesinclude the following. Other duties may be assigned.

• Understand and develop knowledge of FDA regulatory expectations for departmental development.
• Ensure testing is performed accurately and in accordance with GxP, USP, and company standards.

Required Education and Experience

• Bachelors Degree in Chemistry or relevant field
• 3-10 years of experience with HPLC/UPLC analysis, preferably using Empower 3 software
• Familiar with general laboratory instrumentation and equipment: Karl Fischer, micropipettes, pH meter, analytical balance, vortex, centrifuge, volumetric glassware etc.
• Familiar with GMPs, FDA, ICH and OSHA requirements
• Experience using MS word, Excel, and/or relevant applications
• Must be capable of wearing all protective wear as required by regulations/company standards. This includes, but not limited to; mask, gloves, gown, respirator, safety goggles etc.
• Must be capable of working with small delicate pieces of machinery to complete appropriate analysis in a timely manner
• Must be able to work with chemicals used in sample analysis including acids, bases, and solvents following any special safety precautions as required.
• Must have strong organizational skills and exceptional attention to detail
• Must exhibit punctuality and low absenteeism
• Able to work independently, as well 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
• Problem Solving/Analysis
• Quality Driven
• Results Driven
• Technical Capacity
• Thoroughness

Supervisory Responsibility

This position has no supervisory responsibilities.

This job operates primarily in a controlled laboratory environment operating under GxP. This position requires the use of standard office equipment, and frequent standing and walking.

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.

• Ability to lift 25-50 pounds (i.e. equipment and materials relating to the lab)
• Able to sit and/or stand 8-10 hours or more per day as needed

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.

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.

AAP/EEO Statement

Stokes Healthcare is an Equal Employment Opportunity and Affir