Formulation/Filling Team Leader

Job Description Formulation/Filling Team Leader Manufacturing Bloomington, IN (Onsite) Full-time, non-exempt 40 hr/wk, 1st shift General Description While this position has a primary focus of Formulation and Aseptic Filling, all Manufacturing Team Leads actively participate in all the manufacturing operations for the company including: Drug product formulation Aseptic filling Finished dose inspection/labeling/kitting/packaging Sample and Dispense Responsibilities Lead and play major role in onboarding of new operators in area of assignment. Provide back up to the Manufacturing Supervisors. Serve as SME (Subject Matter Expert) in area of assignment. Own, draft, and revise area procedures. Lead sub groups when projects require additional time outside of standard manufacturing shift hours, when necessary. Must be able to work within the FDA regulated environment per 21CFR 210/211 requirements and those established by internal policy and standard operating procedures. Computer experience necessary. Proficiency with Microsoft Office (Outlook, Excel, Word). Experience using equipment HMIs, as well as ERP or inventory systems desired. Attention to detail and good organization skills mandatory. Participate in and fully support process improvement initiatives. Ability to work in both collaborative and independent work situations and environments. Must strictly adhere to all safety requirements, including wearing proper PPE (personal protection equipment) while performing operations, i.e. respirator, safety glasses, gloves, etc. Job requires gowning to work in cleanroom environments. Perform cleaning/disinfecting/sanitization of cleanrooms. Assist in process investigations, writing of deviations, and implementation of CAPAs to continuously improve operations. Ability to stand for a minimum of 4 hours. Must have good documentation practices with clear, legible handwriting. Provide recommendations and implement solutions to resolve equipment and/or process problems in a timely manner. Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes and procedures. General support required of a company where everyone is expected to perform multiple tasks both inside and outside their department to meet the needs of the business. Functions as the subject matter expert (knowledge, skills) in assigned departmental area (i.e. Formulation/Filling, Sampling and Dispensing, Finishing); in alignment with manager's directions. Formulation Precision weighing and measuring of buffers, excipients, API, etc. Ability to use basic lab instruments, such as; pH meter, conductivity meter, pipets. Ability to use basic manufacturing equipment, such as; biosafety cabinets, mixers, pumps, filter testers. Aseptic Filling Install machine change parts and load recipes on fill machine. Staging/loading of components and preparation of fill path. Perform cleaning and VPHP decontamination of isolators. Assist with environmental monitoring. Finishing (Inspection, Labeling, and Kitting) Label and package filled drug product and/or pharmaceutical components per written specifications, SOP's, job aids and batch records. Inspect product and printed materials for defects. Responsible for reconciliation of all controlled printed materials and product. Setup and operation of labeling and packaging equipment and systems. Preparation and use of precision measuring instruments. Skills and Physical Activity Requirements Excellent work ethic and attention to detail. Ability to communicate clearly, both written and verbally. Requires repetitive hand, wrist, arm motions. Hand eye coordination and manual dexterity with small components. Use of small tools and laboratory/production equipment. Clear, legible handwriting. Able to comprehend and execute complex written instructions. Must be able to lift, push, or pull up to 50 pounds. Positive attitude and good judgment. Good time management and organizational skills. Education and Work Experience Requirements High school diploma with minimum 5+ years industry experience (or similarly regulated industry). Associates Degree in an Engineering or Science discipline (desired) with minimum 3+ year industry experience. Bachelor's degree in an Engineering or Science discipline (desired). Benefits Dental insurance - effective day one of employment Health insurance - effective day one of employment Vision insurance - effective day one of employment Health savings account Life & AD&D insurance Short & long term disability Paid time off & holidays Employee Assistance Program Tuition assistance 401(k) with company match Singota Solutions is an Equal Opportunity Employer #J-18808-Ljbffr