Specialist, R&D Formulation

Job Description Date 12/2025 Location 1300 Airport Road, North Brunswick NJ Title Specialist R&D Formulation Department R&D Reports to Manager, R&D FLSA (Exempt or Non-Exempt) Non-Exempt Role Overview The Specialist, R&D Formulation serves as a transitional position between an advanced R&D technician and a Formulator -1. This role requires hands-on execution combined with growing technical ownership of formulation development activities. The individual will lead formulation experiments, support process development and scale-up, and ensure compliant documentation while demonstrating readiness to advance into a Formulator role. Areas of Responsibility Formulation Development & Execution Lead formulation experiments for new product development and optimization of existing products. Design and prepare prototypes and experimental batches at benchtop, pilot, and scale-up levels. Support development of solid oral dosage forms (tablets, capsules, granules). Execute formulation activities independently with minimal supervision while escalating complex challenges appropriately. Collaborate closely with and support senior R&D team members in daily product development activities. Process Development & Scale-Up Support process development, validation, troubleshooting, and technology transfer to manufacturing. Execute pilot-scale and scale-up batches to support commercialization. Partner with Manufacturing and Engineering teams to optimize processes. Equipment Operation & Technical Ownership Set up, operate, clean, and perform changeovers on R&D and pilot-scale equipment, including: Tablet presses Capsule filling machines Coating equipment Granulators Fluid Bed Dryers (FBDs) Ensure equipment is maintained and operated in compliance with SOPs, safety standards, and cGMP requirements. Troubleshoot equipment and process issues using strong technical and analytical skills. Documentation, Compliance & Communication Maintain accurate and compliant documentation (BMRs, logbooks, protocols, reports). Record formulation data, observations, and changes in a timely and clear manner. Ensure adherence to cGMP, SOPs, and regulatory requirements. Communicate updates, results, and project status effectively to R&D and cross-functional teams. Prepare and review technical and customer-facing documents, including: Sample shipment cover letters Commercial invoices and declaration documents for international shipments Tracking and data analysis spreadsheets Cross-Functional Coordination & Operations Coordinate with internal departments to support smooth R&D operations: QC: Sample drop-off and documentation QA: Sample testing, shipment coordination, and results tracking Packaging: Sample transfer and packaging Warehouse/Inventory: Material availability and tracking Purchasing: Requisitions, POs, and delivery timelines Maintenance: Equipment and facility repairs External Facilities (e.g., VanDyke Building): Raw material transfers Request materials through Syspro and ensure availability for trials. Schedule and coordinate meetings across R&D and Purchasing teams. Sample Management, Packaging & Shipping Package, label, and maintain inventory of samples for: Customer evaluations and meetings Internal and external testing Stability studies Ship samples, materials, and documents via FedEx and UPS, including international shipments. Prepare all required shipping documentation and ensure compliance with international regulations. Coordinate with shipping carriers to resolve delays and ensure timely delivery. Inventory, Warehouse & Material Management Maintain organization, labeling, and safety of R&D warehouse and storage areas. Ensure proper labeling and storage of raw materials, packaging materials, and supplier samples. Manage controlled storage requirements (e.g., probiotics in designated rooms/freezers). Track inventory levels, material usage, and delivery timelines. Maintain office and lab supply inventory. Data Tracking & Administrative Support Packages & labels samples for shipments & customer review. Packages all samples for customer meetings & maintains inventory for sample presentation. Packages & labels samples for internal & external testing. Packages & labels samples occasionally for stability trials. Maintains warehouse organization & safety Labels raw materials correctly & maintains organization system for each section of the warehouse. Labels packaging materials to ensure easy retrieval. Labels supplier received raw materials with necessary information for easy retrieval. Ensures probiotic samples are correctly stored in R&D probiotic room or freezer. Ships samples, materials, & documents via FedEx & UPS Ships samples to customers for sample & document review Ships samples to external labs for testing along with sample requisitions. Ships samples internationally, ensuring all documentation required for other countries is provided. Works externally with Fedex/UPS representatives to ensure delayed packages are delivered & documentation is updated correctly. Create, Compose, edits, & reviews written material as necessary to share with appropriate internal departments & customers. Composes cover letters for customer sample shipments Composes required documents for international shipments, such as declaration letters, commercial invoices, & cover letters. Creates excel sheets for tracking & comparison purposes. Reviews material documents to ensure proper storage. Maintains Excel logs for the following: Received raw material from 1300. Incoming sample raw material from suppliers. In-house QC samples for testing & results. External lab sample testing & results. Samples shipped to customers via FedEx & UPS. Creates requisitions through purchasing team & receives Purchase Orders as necessary Creates requisitions & receives PO's through Syspro. Monitors purchased materials for all R&D projects & keeps track of all raw material delivery ETA's Reviews invoices for approval for shipping, lab testing, & other external purchases. Maintains office supply inventory regularly. Continuous Improvement & Development Identify opportunities to improve formulation, processes, and operational efficiency. Participate in 5S, safety, and continuous improvement initiatives. Demonstrate increasing ownership and decision-making to prepare for advancement. Additional Responsibilities Follow all lab safety and PPE requirements. Provide guidance and mentorship to junior technicians. Perform other duties as assigned to support business objectives. Requirements Education & Qualification: Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, or a related scientific field preferred (or equivalent hands-on experience). 1-3 years of experience in pharmaceutical R&D formulation, pilot-scale manufacturing, or related technical roles. Minimum of three (3) years of work experience in nutritionals, supplements, food, or pharmaceutical manufacturing industries. Experience with formulation development (e.g., liquids, powders, tablets, gels, capsules, etc., depending on your industry). Strong understanding of formulation principles, laboratory techniques, and scientific methods. Excellent documentation, organizational, and time-management skills. Ability to interpret data, identify trends, and propose scientifically sound conclusions. Strong communication and teamwork abilities. Proficient with Microsoft Office and lab software (LIMS, ELN, etc., if applicable). Hands-on experience with any of the following processes: Blending/Granulation, Tablet Compression and/or Film Coating, Encapsulation, or Pharmacy/Pre-Weigh Dispensing Certifications, Licenses, Credentials: N/A Skills & Ability Demonstrates ability to work in a team and assist others. Able to follow written instructions precisely and perform basic math calculations as required. Understands and is knowledgeable of cGMP, OSHA standards etc. Mechanically inclined to understand inner workings of equipment. Knowledge of any of the following processes: Blending/Granulation, Tablet Compression and/or Film Coating, Encapsulation, or Pharmacy/Pre-Weigh Dispensing. Demonstrates the ability to read and write English in order to be able to understand the industry regulated instruction sheets. Has experience with the following: Google Suite, Microsoft Excel, Word, PowerPoint, & Teams, Syspro8 Physical Requirements (lifting, etc.): Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds. Must stand and walk on the production floor for a minimum of 6 hours per shift Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances. Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on the floor to clean under the equipment. Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators. Work Environment (Office, Warehouse, temperature extremes, etc.): Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. Job Description Acknowledgement I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodation. US Pharma Lab