Sr. Manufacturing Technician

Tris Pharma, Inc • Monmouth Junction, NJ • 4h ago

DescriptionTris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Senior Manufacturing Technician on 3rd shift. Days/Hours are M-F 10:00 PM - 6:00 AM The Senior Manufacturing Technician is responsible for supporting and assisting in the production of a range of pharmaceutical products in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications. She/he operates, sets-up, and maintains various pharmaceutical production equipment as assigned, and thoroughly and accurately documents all activities to ensure compliance with regulatory guidelines. ESSENTIAL FUNCTIONSPrimary duties/responsibilities - Supports and assists in the manufacture of pharmaceutical products according to SOPs, cGMPs, FDA standards and batch record specifications- Performs the day to day activities of the production process as assigned, including but not limited to: weighing, blending, filling, compression, coating and/or granulation, etc.- Assists in set up, change over and test runs of equipment for various sized batches and various products, as needed- Collaborates with other production staff and departments- Accurately and consistently completes and documents batch records and other required paperwork- Precisely follows work orders and specifications- Adheres to all plant safety policies and procedures RequirementsRequirementsMinimum education and years of relevant work experienceHigh school diploma or equivalent and minimum 5 years experience working in a cGMP regulated environment. SPECIAL KNOWLEDGE/SKILLS/ABILITIES REQUIRED - Strong working knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes- Strong working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs- Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc.- Basic PC skills- Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members- Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines- Planning, organization and time management skills including the ability to support and prioritize multiple projects- Fluent in English (verbal and written)- Ability to identify and distinguish colors- Ability and willingness to work additional hours as required by business needs Special knowledge or skills needed and/or licenses or certificates preferred- Solid dose manufacturing experience- Associates degree or some college coursework Travel requirements0% Physical requirementsManufacturing based positionAbility to lift up to 50 lbsAbility t

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