What are the responsibilities and job description for the Manufacturing Specialist- Formulation, 3rd Shift position at INCOG BioPharma Services?
The primary responsibility of the 3rd Shift 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
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.
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