Manufacturing Specialist - Formulation, Weekend Shift
About The Position
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. 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. This is a weekend shift role scheduled for Friday – Sunday, with both day and night schedules available.
Requirements
- High School diploma
- 1 year of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment or 3+ years of relevant work experience
- Working knowledge of MS Office, MS Word, MS Excel, Windows or equivalent is required.
Nice To Haves
- 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
