SR Product Development/Manufacturing Technician

Profile

  

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**MEMBERS ONLY**SIGN UP NOW***., Inc. (****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. 

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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. 

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

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ESSENTIAL FUNCTIONS 

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Primary duties/responsibilities

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

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

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

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

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• Maintains the lab and process areas clean and organized 

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

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

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· Maintains current inventories of raw materials and product batches

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

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Requirements

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KNOWLEDGE/SKILLS/ABILITIES REQUIRED

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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 

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• 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 

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• Knowledge of pharmaceutical processing technologies and scale-up REQUIRED

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• Experience working in a cGMP regulated environment REQUIRED

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• Strong record keeping ability REQUIRED

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• Ability to manage multiple duties and assignments REQUIRED

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• Proficiency with Microsoft Word REQUIRED

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Physical requirements

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Laboratory/Manufacturing based position 

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Ability to lift up to 30 lbs

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**MEMBERS ONLY**SIGN UP NOW***., 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. **MEMBERS ONLY**SIGN UP NOW***., Inc. is an Equal Opportunity Employer.

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#LI - DNI

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