What are the responsibilities and job description for the Manufacturing Specialist- Formulation position at INCOG BioPharma Services?
The primary responsibility of the Manufacturing Specialist in Formulation is to weigh/dispense, setup/operate equipment to produce the bulk drug product for sterile manufacturing. They 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 demonstrate mentor and leadership skills to motivate manufacturing personnel, drive timely production activities and work effectively with internal partners, clients, and vendors.
Key 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.
Requirements:
- 1 year of GMP pharmaceutical experience focused on formulation and dispensing
- 1 year of experience with the installation, operation, cleaning, and maintenance of pharmaceutical equipment
- High school diploma
- Working knowledge of MS Office
Additional Preferences:
- BS in biological sciences/ biotechnology
- 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
