Formulation/Filling Team Leader

Formulation/Filling Team LeaderSingota Solutions is a contract development and manufacturing organization (CDMO) focused on getting products to patients faster by being agile, accountable, and transparent. Our team of experts believe in collaboration and customizing our services to assist our clients through the drug development process. Our key services include drug formulation development, analytical testing, aseptic filling, pharmaceutical labeling and kitting, and supply chain management.Why join Team Singota? We pride ourselves on a high-trust, high-accountability environment where we lift each other up. When you join Singota, you are a part of a team that respects, supports, and values its people. We celebrate wins together, brainstorm solutions together, and genuinely enjoy the work we do. The result? A team that's not just efficient, but also passionate, dedicated, and fun to work with.Job title: Formulation/Filling Team LeaderDepartment: ManufacturingLocation: Bloomington, IN (Onsite)Position Type: Full-time, non-exemptHours: 40 hr/wk, 1st shiftGeneral 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 formulationAseptic fillingFinished dose inspection/labeling/kitting/packagingSample and DispenseGeneral: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, pipetsAbility to use basic manufacturing equipment, such as; biosafety cabinets, mixers, pumps, filter testersAseptic filling:Install machine change parts and load recipes on fill machineStaging/loading of components and preparation of fill pathPerform cleaning and VPHP decontamination of isolatorsFinishing (Inspection, Labeling, and Kitting):Label and package filled drug product and/or pharmaceutical components per written specifications, SOP's, job aids and batch recordsInspect product and printed materials for defectsResponsible for reconciliation of all controlled printed materials and productSetup and operation of labeling and packaging equipment and systemsPreparation and use of precision measuring instrumentsRequirements Skills and Physical Activity Requirements:Excellent work ethic and attention to detailAbility to communicate clearly, both written and verballyRequires repetitive hand, wrist, arm motionsHand eye coordination and manual dexterity with small componentsUse of small tools and laboratory/production equipmentClear, legible handwritingAble to comprehend and execute complex written instructionsMust be able to lift, push, or pull up to 50 poundsPositive attitude and good judgmentGood time management and organizational skillsEducation 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 experienceBachelor's degree in an Engineering or Science discipline(desired)Singota Solutions is an Equal Opportunity Employer