Manufacturing Specialist, Formulation

INCOG BioPharma Services; Fishers (IN); On-site; USD 60,000 - 85,000; Full time

Job summary

INCOG BioPharma Services seeks a Manufacturing Specialist (Formulation) to join our Operations team in Fishers, IN. The role focuses on sterile drug product formulation, aseptic filling support, and strict adherence to GMP protocols.

The ideal candidate will have GMP formulation experience or related hands-on work with GMP filling equipment, plus strong data/documentation skills and the ability to collaborate across teams.

Qualifications

• High School diploma is required.
• 1 year of GMP pharmaceutical formulation experience or 3+ years of relevant work experience with operation, cleaning, and maintenance of pharmaceutical GMP filling equipment
• Working knowledge of MS Office, MS Word, MS Excel, Windows or equivalent is required.

Responsibilities

• Follow production and manufacturing procedures.
• Perform duties in Grade C, D, and controlled non-classified cleanrooms.
• Perform cleaning and sanitization, equipment preparation, and support aseptic filling duties as needed.
• Operate formulation equipment including setup and post cleaning.
• Accurately document data and complete batch records.
• Execute validation/engineering protocols as needed.
• Train others in various manufacturing tasks including, but not limited to: formulation/dispensing, sanitization, component and equipment preparation.
• Perform routine maintenance and troubleshooting of production equipment.
• Support equipment optimization efforts and continuous improvement efforts.
• Collaborate and communicate with cross functional teams.
• Work flexible hours to ensure production facility coverage.

Skills

Communication

Team collaboration

Attention to detail

Documentation

Education

High School diploma

Tools

MS Office

MS Word

MS Excel

Windows OS

ERP systems

Job description

Manufacturing Specialist - Formulation Summary

INCOG BioPharma is seeking a highly motivated individual with subject matter expert (SME) capabilities in the formulation of sterile drug products. The Manufacturing Specialist (Formulation) is a key role within INCOG BioPharma Operations. The ideal candidate must have experience in pharmaceuticals and/or biologics formulation.

Essential Job Functions:

• Follow production and manufacturing procedures.
• Perform duties in Grade C, D, and controlled non-classified cleanrooms.
• Perform cleaning and sanitization, equipment preparation, and support aseptic filling duties as needed.
• Operate formulation equipment including setup and post cleaning.
• Accurately document data and complete batch records.
• Execute validation/engineering protocols as needed.
• Train others in various manufacturing tasks including, but not limited to: formulation/dispensing, sanitization, component and equipment preparation.
• Perform routine maintenance and troubleshooting of production equipment.
• Support equipment optimization efforts and continuous improvement efforts.
• Collaborate and communicate with cross functional teams.
• Work flexible hours to ensure production facility coverage.

Special Job Requirements:

• High School diploma
• 1 year of GMP pharmaceutical formulation experience or 3+ years of relevant work experience with the operation, cleaning, and maintenance of pharmaceutical GMP filling equipment
• Working knowledge of MS Office, MS Word, MS Excel, Windows or equivalent is required.

Additional Preferences:

• BS in biological sciences/biotechnology or related field.
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic. processing (fill and finish) general Good Manufacturing Practices (cGMP).
• 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.

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.

Qualified applicants must be authorized to work in the United States on a full‑time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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