Formulation Manufacturing Specialist – Aseptic Fill

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

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.