Manufacturing Team Lead - Filling, 2nd shift

Overview

INCOG BioPharma is seeking an individual with subject matter expert (SME) capabilities in the filling and formulation of sterile drug products. The Team Lead is a key role within INCOG BioPharma Operations. 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 records and form entries. 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. This team member will ensure compliance with quality systems, policies, procedures, and cGMP practices and collaborate effectively with internal partners, clients, and vendors. This is a 2nd Shift opportunity.

Essential Job Functions

• Proven subject matter expert within manufacturing area with advanced troubleshooting, coordination, and communication skills
• Provide leadership to manufacturing personnel to identify & eliminate waste, implement standard-work, and provide problem solving & solution implementation assistance
• May lead shift handover or act as a shift lead in the absence of a supervisor; leadership (supervisory / management) experience preferred
• Computer efficiency in Microsoft Office, Outlook, and the ability to use enterprise software
• Assist Production Supervisor, supporting a team of 6 to 10 associates daily, to prepare and fill syringes and vials
• Assist in writing and implementing area's process documents
• Operate equipment in compliance with SOPs
• Assure compliance with cGMP (current good manufacturing practices)
• Complete and review associated production records, logbooks and forms
• Train new associates in accordance with inspector certification procedures
• Mentor new associates
• Train new employees to perform manufacturing inventory transactions in the ERP system
• Perform duties gowned in Grade C, D, and controlled non-classified cleanrooms
• Perform cleaning and sanitization activities as needed
• Collaborate and communicate with cross functional teams
• Work flexible hours to ensure production facility coverage

Requirements

About INCOG BioPharma

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.

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