Method Development Scientist

Automatic Data Processing, Inc.; Mount Laurel Township (NJ); On-site; USD 72,000 - 88,000; Full time

Benefits offered by this job

Medical insurance

Dental & Vision

401K match

Bonus program

Paid time off

Job summary

Stokes Healthcare in Mount Laurel, NJ is seeking a Method Development Scientist to oversee development and validation of analytical methods for pharmaceutical products. You will ensure data credibility, conduct experiments, and document findings to support regulatory compliance.

The role requires a strong background in HPLC/UPLC/GC, Empower 3, and GLP/GxP practices, with leadership responsibilities including mentoring junior scientists and collaborating across functions to advance projects.

Qualifications

• Bachelor's in Chemistry or related field.
• Minimum 5 years in pharma analytical testing.
• Knowledge of HPLC/UPLC/GC and Empower 3 software.
• Proficiency in statistics and experimental design.
• Strong documentation and regulatory writing skills.

Responsibilities

• Develop and optimize analytical methods for pharmaceutical compounds.
• Stay updated with latest analytical techniques and technologies.
• Collaborate with cross-functional teams to support development projects.
• Lead and mentor junior scientists and provide technical guidance.
• Ensure testing is performed per cGMP, USP, ICH and FDA standards.
• Author and revise SOPs, protocols and data reports.
• Lead equipment qualification and calibration activities.
• Adhere to laboratory safety and regulatory standards.

Skills

Analytical method development

HPLC/UPLC/GC

Empower 3 software

Statistical analysis

Regulatory compliance

SOP writing

GxP knowledge

Lab instrumentation

Education

Bachelor's in Chemistry or related field

Tools

Karl Fischer titrator

pH meter

Analytical balance

Micropipettes

Centrifuge

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 Title

Method Development Scientist

Starting at 80K based on experience plus twice a year bonuses.

JOB DESCRIPTION

Summary/Objective

Development and validation of analytical methods to test and analyze products. Assure the accuracy and credibility of data from analytical studies. Conduct experiments, analyze results, and record findings.

Essential Duties and Responsibilities

include the following. Other duties may be assigned.

• Develop and optimize analytical methods for the analysis of pharmaceutical compounds, ensuring accuracy and precision in the results.
• Conduct research and stay updated with the latest advancements in analytical techniques and technologies, applying them to improve method development processes.
• Collaborate with cross-functional teams to support development projects, providing analytical expertise and guidance throughout the lifecycle.
• Lead and mentor junior scientists, oversee their work, and provide technical support and troubleshooting assistance as needed.
• Ensure testing is performed in accordance with cGMP, USP, ICH, FDA and company standards
• Authors/revises SOPs, protocols and data reports
• Lead qualification and calibration of equipment
• Adhere to laboratory safety requirements and regulatory standards.

Regulatory Responsibilities

include 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
• Minimum 5 years of experience in pharmaceutical industry performing analytical testing or a combination of experience with advanced degree(s)
• In-depth knowledge of analytical methods and techniques used in the development of pharmaceutical products, including HPLC, UPLC, GC, and spectroscopic methods preferably using Empower 3 software
• Proficient in statistical analysis and experimental design to optimize analytical methods and troubleshoot method-related issues.
• Excellent problem-solving skills to identify and resolve technical challenges encountered during method development and validation processes
• Advanced knowledge of general laboratory instrumentation and equipment such as Karl Fischer titrator, micropipettes, pH meter, analytical balance, vortex, centrifuge, volumetric glassware etc.
• Strong understanding of regulatory guidelines (such as FDA, ICH, and USP) pertaining to analytical method development, validation, and transfer
• Experience with resolving laboratory investigations and chromatographic issues for root cause
• Experience interacting with auditors/responding to audit findings preferredStrong technical writing background including but, but not limited to authoring protocols and reports, standard operating procedures (SOP’s), and maintaining ALCOA+ compliant laboratory records (notebooks, datasheets, etc.)
• 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
• Strong analytical and problem-solving abilities and innovation
• 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.

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.

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Mathematical Skills

Uses addition, subtraction, multiplication and the division of numbers including decimals and fractions when checking of reports, forms, records and comparable data where interpretation is required involving basic skills knowledge.

Reasoning Ability

Must have the ability to solve practical problems and deal with a variety of concrete variables in situations where substantial standardization exists. Must be able to interpret instructions furnished in written, oral, and diagram or schedule form.

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 Affiative Action Employer.