(SR) Product Development/Manufacturing Technician

Tris Pharma, Inc. (www.trispharma.com) is a rapidly growing, technology-driven pharmaceutical company engaged in branded and generic product development. Located in Monmouth Junction, New Jersey, Tris has an opening in the Product Development (PD) department for a Technician or Senior Technician. 

Using your hands-on experience in pharma manufacturing the chosen candidate is responsible for supporting scientists in the PD department with their day-to-day laboratory and batch manufacturing work, as well as maintaining the formulation lab and process areas clean and organized. She/he follows the instructions and guidance of supervisor/scientists and performs experimental work in compliance with current Good Laboratory Practices (cGLPs), current Good Manufacturing Practices (cGMPs), Good Documentation Practices (cGDPs), Protocols, Standard Operating Procedures (SOPs) and company policies. 

This is a 1st shift position 8AM to 5PM.  

ESSENTIAL FUNCTIONS 

Primary duties/responsibilities

• Carries out responsibilities in accordance with the organization’s policies, SOPs, and state, federal and local laws 

• Performs pre-formulation and lab scale formulation experiments and batch manufacture as per instructions 

• Supports manufacture of scale-up and submission batches in production facility as per protocols and batch records

• Sets up, runs and cleans all PD equipment and instruments per SOPs and department requirements. Supports equipment calibration and qualification activities 

• Maintains the lab and process areas clean and organized 

• Documents all study details and results in laboratory notebooks and batch records compliant with GDP

· Routinely inspects PD equipment and instruments for working conditions, and informs supervisor of any malfunction and breakdown

· Maintains current inventories of raw materials and product batches

• Assists with basic Controlled Substances Drug Enforcement Agency (DEA) related activities, as needed

Requirements

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

High school diploma or equivalent education AND minimum 3 years experience working in Manufacturing, R&D, Formulation or Product Development departments of a pharmaceutical or biotechnology or related company REQUIRED 

• Hands-on experience setting up, operating and cleaning pharmaceutical equipment and instruments for solid and liquid dosage forms such as tablet press, fluid bed coaters, granulators, blenders, extruders, etc. REQUIRED 

• Knowledge of pharmaceutical processing technologies and scale-up REQUIRED

• Experience working in a cGMP regulated environment REQUIRED

• Strong record keeping ability REQUIRED

• Ability to manage multiple duties and assignments REQUIRED

• Proficiency with Microsoft Word REQUIRED

Physical requirements

Laboratory/Manufacturing based position 

Ability to lift up to 30 lbs

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.

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