Technician, R&D Formulation
hace 17 días
North Brunswick
Job Description Job Description Date 10/2025 Location 1200 Airport Road, North Brunswick NJ Title Technician, R&D Formulation Department Research & Development Reports to Director, Research & Development FLSA (Exempt or Non-Exempt Non-Exempt Role Overview The Formulation Technician is responsible for supporting the formulation and manufacturing processes by accurately weighing, mixing, and processing raw materials in accordance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (cGMP), and batch documentation requirements. This role involves hands-on operation and maintenance of various pharmaceutical production equipment and requires close adherence to quality, safety, and regulatory standards. Areas of Responsibility Technician, R&D -Level 1, Works under close supervision; learns formulation procedures, documentation, and equipment operation. Technician, R&D -Level 2 Works independently on complex formulation and scale-up activities; may train junior staff Technician, R&D -Level 3 Operates with minimal supervision; recognized technical expert and mentor within the R&D team. Develops and updates SOPs, batch records, and training materials. Oversees equipment readiness, preventive maintenance, and calibrations. Mentors’ technicians and ensures high-quality documentation and compliance. Supports technology transfer and production readiness reviews Key Responsibilities Level 1, 2 & 3 • Accurately weigh and transfer raw materials using calibrated balances and scales in accordance with approved batch records and formulation guidelines., • Perform formulation and manufacturing activities for pilot, scale-up, and commercial batch production., • Operate equipment for mixing, blending, granulation, and other material processing functions in support of pharmaceutical product development and manufacturing., • Complete and maintain accurate, compliant, and timely documentation, including Batch Manufacturing Records (BMRs), Logbooks, Protocols, and related forms in accordance with cGMP and SOP requirements., • Assist in the development and optimization of formulations for various dosage forms such as tablets, capsules, and granules, under the direction of senior formulation scientists or supervisors., • Independently execute and monitor benchtop, pilot-scale, and manufacturing scale-up batches with minimal supervision., • Set up, operate, clean, and perform changeovers on R&D and pilot-scale manufacturing equipment, including but not limited to:, • Tablet Presses, • Capsule Filling Machines, • Coating Machines, • Granulators, • Fluid Bed Dryers (FBDs), • Ensure equipment is properly maintained, sanitized, and operated in compliance with SOPs, safety protocols, and current Good Manufacturing Practices (cGMP)., • Proactively identify and troubleshoot issues during formulation development, demonstrating strong problem-solving skills and an ability to anticipate potential risks or failures., • Adhere strictly to all company policies, safety guidelines, and regulatory requirements., • Participate in routine housekeeping, equipment cleaning, and 5S/continuous improvement initiatives to maintain a safe and efficient working environment., • Perform additional duties and responsibilities as assigned by management to support departmental and organizational goals. Requirements Education & Qualification: Technician, R&D -1 • Requires High School diploma or GED, Associate degree preferred., • 1 to 4 years of experience working in a nutraceutical/pharmaceutical, biotech, or food manufacturing environment, regulated by GMP standards and requirements., • Specific experience in oral solid dosage manufacturing, blending, compression, pan coating, fluid bed, or encapsulation manufacturing processes will be a plus. Technician, R&D -2 • Requires High School diploma or GED, Associate degree preferred., • 6 to 10 years’ experience working in a nutraceutical/pharmaceutical, biotech, or food manufacturing environment, regulated by GMP standards and requirements., • Specific experience in oral solid dosage manufacturing, blending, compression, pan coating, fluid bed, or encapsulation manufacturing processes. Technician, R&D -3 • Associate’s or Bachelor’s degree in Chemistry, Biology, Engineering, or related scientific field, • 3 to 12 years’ experience working in a nutraceutical/pharmaceutical, biotech, or food manufacturing environment, regulated by GMP standards and requirements., • Specific experience in oral solid dosage manufacturing, blending, compression, pan coating, fluid bed, or encapsulation manufacturing processes. Certifications, Licenses, Credentials: • N/A Skills & Ability • Requires hands-on experience or knowledge to set-up & operate Tablet, Capsule, Granulation manufacturing process equipment such as Tablet Press, Capsule Filling, Coating, Granulator, Fluid Bed Dryers, etc. and the ability to troubleshoot this equipment., • Utilizes problem-solving skills to investigate and troubleshoot product issues and recommend solutions for issues such as sticking, picking, capping, chipping, compressibility, delamination, etc., • Works independently or in a team assisting others., • Performs basic math calculations and follow written instructions with accuracy and pay attention to detail., • Able to follow and understand cGMP, OSHA standards etc., • Able to distinguish different shades of colors., • Intermediate user of MS Office, Excel, Word, and Outlook, • Complies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP’s, GLP, documentation) when performing the assigned activity., • Demonstrates above average written communication skills in the English language to follow the industry regulated instruction sheets. Physical Requirements (lifting, etc.): • The employee is frequently required to sit (50%), stand, and walk (50%) at a lab bench., • Able to lift up to 35 lbs.; occasionally lift and move up to 50 pounds., • Able to stand and walk on the production floor a minimum of 6 hours per shift., • Uses hands to finger, handle or feel, or to operate or to control objects. Able to lift up to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances., • Able to occasionally work on a rolling ladder or step stool, or to lean over equipment as well as kneeling on the floor to clean under the equipment., • Able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses/goggles and respirator. Work Environment (Office, Warehouse, temperature extremes, etc.): • Work is regularly performed inside a laboratory 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., • Occasionally walks through warehouse or manufacturing workplace and will be required to wear appropriate PPE for each work area. 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 9:00 am to 5:30 PM
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