Manufacturing Team Lead (Weekend Night Shift)

INCOG BioPharma Services; Fishers (IN); On-site; USD 65,000 - 85,000; Full time

Job summary

A leading pharmaceutical company located in Fishers, IN, is seeking a Manufacturing Team Lead. This role involves managing manufacturing activities, ensuring compliance with cGMP standards, and leading a team in efficient production practices. Ideal candidates should have a High School diploma and at least 5 years of experience in pharmaceutical manufacturing. Leadership experience is strongly preferred. This position requires strong communication skills and the ability to work flexible hours to meet production needs.

Qualifications

• Minimum 5 years of GMP pharmaceutical experience in drug product manufacturing preferred.
• Leadership experience in manufacturing is preferred.

Responsibilities

• Drive and support manufacturing activities including equipment preparation and filling.
• Ensure compliance with quality systems and cGMP practices.
• Mentor and train new associates.
• Complete and review production records and forms.

Skills

Advanced troubleshooting

Coordination

Communication skills

Mathematical skills

Documentation skills

Observation skills

Initiative-taking

Effective organization skills

Education

High School diploma

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

ERP software

Job description

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 neededCollaborate 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 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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