Sterile Formulation Specialist — Hands-On GMP

INCOG BioPharma; Fishers (IN); On-site; USD 60,000 - 90,000; Full time

Job summary

INCOG BioPharma in Fishers, IN is seeking a Manufacturing Specialist - Formulation with hands-on experience in sterile drug product formulation and GMP environments.

The role focuses on weighing, dispensing, setting up equipment, operating sterile manufacturing lines, documenting batch records, and supporting continuous process improvements while mentoring team members and coordinating with internal partners and vendors.

Qualifications

• 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.

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.

Education

High School diploma

BS in biological sciences/biotechnology or related field

Tools

MS Office

Job description

INCOG BioPharma in Fishers, IN is seeking a Manufacturing Specialist - Formulation with hands-on experience in sterile drug product formulation and GMP environments.

The role focuses on weighing, dispensing, setting up equipment, operating sterile manufacturing lines, documenting batch records, and supporting continuous process improvements while mentoring team members and coordinating with internal partners and vendors.