Manufacturing Team Lead SummaryINCOG BioPharma is seeking an individual with subject matter expert (SME) capabilities in the inspection and/or packaging of sterile drug products. The Team Lead is a key role within INCOG BioPharma Operations. The ideal candidate must have experience in the manufacturing of pharmaceutical drug products.This position is vital for our weekend operations, 12‑hour shifts.The primary responsibility of the Manufacturing Team Lead is to drive and support manufacturing activities in the area of equipment preparation, filling and formulation while providing in‑process daily review of executed batch record and form entries. In addition, they will execute and perform standard work as per standard procedures and manufacturing batch records. They will be responsible for meeting/exceeding production standards, maintaining product quality, and minimizing/preventing equipment downtime. The ideal candidate will ensure compliance with quality systems, policies, procedures, and cGMP practices and collaborate effectively with internal partners, clients, and vendors.Essential Job Functions:Proven subject matter expert within manufacturing area with advanced troubleshooting, coordination, and communication skillsProvide leadership to manufacturing personnel to identify & eliminate waste, implement standard‑work, and provide problem solving & solution implementation assistanceMay lead shift handover or act as a shift lead in the absence of a supervisorLeadership (Supervisory/Management) experience preferredComputer efficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise softwareAssist Production Supervisor, supporting a team of 6 to 10 associates daily, to prepare and fill syringes and vialsFollow production and manufacturing proceduresAssist in writing and implementing area's process documentsOperate equipment in compliance with SOPsAssure compliance with cGMP requirements (current good manufacturing practices)Complete and review associated production records, logbooks and formsTrain new associates in accordance with inspector certification proceduresMentor new associatesTrain new employees to perform manufacturing inventory transactions in the ERP systemPerform duties gowned in Grade C, D, and controlled non‑classified cleanroomsPerform cleaning and sanitization activities as neededCollaborate and communicate with cross functional teamsWork flexible hours to ensure production facility coverageMinimum Education and Experience:High School diploma required, minimum 5 years of GMP pharmaceutical experience in drug product manufacturing or equivalent leadership experience is strongly preferred.GMP experience preferredAdditional Preferences:Previous manufacturing leadership experienceGood math and documentation skillsAbility to perform repetitive tasksAbility to learn and adapt to innovative ideasGood observation skillsInitiative‑taking and CollaborativeEffective organization skills and diligentAbility to work with minimal supervisionAdditional info about INCOG BioPharma Services:At INCOG BioPharma we have built a world‑class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long‑term value for our customers, we are committed to a service‑culture mindset, technical excellence, and a collaborative and team‑centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke‑free campus.INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.By submitting your resume and details, you are declaring that the information is correct and accurate.#J-18808-Ljbffr