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The Manufacturing Specialist is a key technical role within INCOG BioPharma Operations. The ideal candidate must have experience in pharmaceuticals and/or biologics and GMP manufacturing.

The Manufacturing Specialist will be expected to work hands-on, be actively involved in continuous process improvements while taking ownership of the quality and quantity of product produced. The ideal candidate should possess a strong mechanical aptitude with strong trouble shooting skills on filling manufacturing equipment. They should demonstrate mentor and leadership skills to motivate manufacturing personnel, drive timely production activities and inspire problem solving & solution driven thinking.

This is a 2nd shift position with typical hours Monday-Friday from 3:00PM-11:30PM.

• Follow production and manufacturing procedures.
• Perform duties in Grade C, D, and controlled non-classified cleanrooms.
• Perform aseptic manipulations within Grade A isolators.
• Safely operate production equipment including setup and changeovers.
• Lead batch start up activities and execution of production cycles
• Accurately document data and complete batch records.
• Execute validation/engineering protocols as needed.
• Train others in various manufacturing tasks including, but not limited to: fill/finish, sanitization, component and equipment preparation.
• Maintain production equipment and troubleshoot issues.
• Support equipment optimization efforts and continuous improvement efforts.
• Resolve issues that arise in day to day running of operation and providing timely responses and solutions.
• SME for filling equipment and supporting systems.
• Participate and/or support process FMEAs to understand process and product risks as a pre-requisite for process validation.
• Provide technical support to manufacturing activities.
• Apply Good Engineering Practices (GEP) to drive site engineering and operational excellence.
• Work flexible hours to ensure production facility coverage.

• High School diploma and 7 years of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.
• Working knowledge of MS Office, MS Word, MS Excel, Windows or equivalent is required.
• Must have previous experience with pharmaceutical aseptic processing (fill and finish) cGMP.

• BS in biological sciences/biotechnology and 1 year of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.
• Excellent communication skills.
• Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.
• Ability to learn and operate a range of industry systems including and not limited to ERP and inventory management systems.

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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