Manufacturing Associate, Specialist, 3rd shift

About the role

INCOG BioPharma is seeking a Manufacturing Specialist (Formulation) to join our operations team. The role requires SME capabilities in the formulation of sterile drug products and involves hands-on production duties in cleanrooms.

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

• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), and cGMP
• 1 year of pharmaceutical formulation experience or 3+ years of experience with the operation, cleaning, and maintenance of pharmaceutical filling equipment
• Working knowledge of MS Office, MS Word, MS Excel, Windows or equivalent

Qualifications

• BS in biological sciences/biotechnology or related field
• 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

Skills

• Knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), and cGMP
• Experience with pharmaceutical formulation and filling equipment operation
• Strong organizational and documentation skills
• Effective communication and training abilities
• Technical aptitude and problem-solving skills

Benefits

INCOG BioPharma offers a competitive compensation package, comprehensive health insurance, retirement plans, and opportunities for professional growth and development.

Pay

The salary range for this position is $50,000 - $60,000 annually, commensurate with experience.

Schedule

This is a 3rd shift position with typical hours of 1:30PM-7:30AM Sunday-Thursday.