Manufacturing Team Lead (Day Shift)

INCOG BioPharma Services•Fishers, IN

1d•Onsite

About The Position

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. 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. By submitting your resume and details, you are declaring that the information is correct and accurate.

Requirements

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
Leadership (Supervisory/Management) experience preferred
Computer efficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software
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

Nice To Haves

Previous manufacturing leadership experience

Responsibilities

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
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