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Biofarma Group · 3 months ago

Technician, R&D Formulation

North Brunswick, NJ, US

Full-time

Onsite

Entry, Mid, Senior Level

$23/hr - $38/hr

1+ years exp

Biofarma Group is seeking a Technician for their R&D Formulation team. The Formulation Technician will support the formulation and manufacturing processes by accurately weighing, mixing, and processing raw materials while adhering to quality and regulatory standards.

CosmeticsHealth CareManufacturingPharmaceutical

Responsibilities

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

Qualification

CGMP complianceOral solid dosage manufacturingFormulation developmentTablet press operationCapsule filling operationGranulation processProblem-solving skillsBasic math skillsMS Office proficiencyTeamworkAttention to detailWritten communication

Required

High School diploma or GED for Technician, R&D -1

1 to 4 years of experience working in a nutraceutical/pharmaceutical, biotech, or food manufacturing environment, regulated by GMP standards and requirements for Technician, R&D -1

High School diploma or GED for Technician, R&D -2

6 to 10 years' experience working in a nutraceutical/pharmaceutical, biotech, or food manufacturing environment, regulated by GMP standards and requirements for Technician, R&D -2

Associate's or Bachelor's degree in Chemistry, Biology, Engineering, or related scientific field for Technician, R&D -3

3 to 12 years' experience working in a nutraceutical/pharmaceutical, biotech, or food manufacturing environment, regulated by GMP standards and requirements for Technician, R&D -3

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

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 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

Preferred

Associate degree preferred for Technician, R&D -1

Associate degree preferred for Technician, R&D -2

Associate's or Bachelor's degree in Chemistry, Biology, Engineering, or related scientific field for Technician, R&D -3

Specific experience in oral solid dosage manufacturing, blending, compression, pan coating, fluid bed, or encapsulation manufacturing processes will be a plus for Technician, R&D -1

Specific experience in oral solid dosage manufacturing, blending, compression, pan coating, fluid bed, or encapsulation manufacturing processes for Technician, R&D -2

Specific experience in oral solid dosage manufacturing, blending, compression, pan coating, fluid bed, or encapsulation manufacturing processes for Technician, R&D -3