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Job Description
Simtra BioPharma Solutions is seeking a Formulation Group Leader to join their Manufacturing Leadership Team. This role is crucial in ensuring that finished products meet required specifications by coordinating the activities of Formulation Operators. The Formulation Group Leader provides decision-making and oversight to maintain compliance with regulatory guidelines and Simtra's Standard Operating Procedures. This position supports quality operations on the production floor and communicates effectively with team members and management.
Responsibilities include:
- Preparing media and buffer solutions
- Operating Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
- Operating general production equipment
- Monitoring and recording critical process parameters
- Completing paperwork following GDP/GMP guidelines
- Performing routine maintenance and cleaning of production equipment
- Performing sampling using aseptic techniques
- Participating on Continuous Improvement Teams
- Training and mentoring team members
- Troubleshooting process problems and responding to process alarms
Requirements:
- High school diploma or GED required
- 6 months of previous Pharmaceutical or Manufacturing experience preferred
- Ability to work independently
- Good communication and interpersonal skills
- Good documentation skills
- Basic computer and math skills
- Knowledge of aseptic manufacturing practices and standard operating procedures
- Ability to understand, speak, read and write English
Simtra BioPharma Solutions offers:
- Day One Benefits (Medical & Dental Coverage, Flexible Spending Accounts, etc.)
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program (Paid Holidays, Paid Time Off, Paid Parental Leave)
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Employee Ownership Plan
- Onsite Campus Amenities (Workout Facility, Cafeteria, Credit Union)
