Manufacturing Team Lead (Day Shift)

Manufacturing Team Lead Summary

INCOG 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 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 Word, Excel, and 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

• Follow production and manufacturing procedures

• Assist in writing and implementing area’s process documents

• Operate equipment in compliance with SOPs

• Assure compliance with cGMP requirements (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

Minimum 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 preferred

Additional Preferences:

• Previous manufacturing leadership experience

• Good math and documentation skills

• Ability to perform repetitive tasks

• Ability to learn and adapt to innovative ideas

• Good observation skills

• Initiative-taking and Collaborative

• Effective organization skills and diligent

• Ability to work with minimal supervision

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we are building 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.

We are in the process of constructing the GMP facility and organization from the ground-up, which gives us the opportunity to leverage the knowledge we’ve gained over our careers to “do it right” in all respects.  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.

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