Formulation Group Lead - Shift 2

Simtra BioPharma Solutions•Bloomington, IN

1d•Onsite

About The Position

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization (CDMO), partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, Simtra offers a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Their product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines, all directly injected into patients worldwide. Simtra emphasizes quality and continuous improvement, adhering to the highest quality and regulatory standards. Beyond cGMP manufacturing, they provide support services such as formulation and development, lyophilization optimization, global regulatory support, and secondary packaging. The teams are dedicated to helping clients scale, innovate, and deliver life-changing medicines to patients globally. The Formulation Group Leader is a member of the Manufacturing Leadership Team, reporting directly to the Manufacturing Supervisor. This role provides direct support to manufacturing to ensure finished products meet required specifications by coordinating the activities of Formulation Operators in the manufacturing areas. The Formulation Group Leader offers decision-making and oversight to ensure compliance with all regulatory agency regulations and guidelines, as well as Simtra Standard Operating Procedures. This position fully supports and drives quality operations on the production floor, communicating effectively with production team members, multiple levels of management, and other customer support departments. The Formulation Group Leader fosters an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. Hours for this position are Monday-Thursday 2PM-12:30AM (4/10hr days).

Requirements

High school diploma or GED required
Ability to work independently
Good communication skills
Good documentation skills, including legible handwriting
Good interpersonal skills
Basic computer skills
Basic math skills
Knowledge of aseptic manufacturing practices
Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert
Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

Nice To Haves

6 months of previous Pharmaceutical or Manufacturing experience preferred

Responsibilities

Prepare media and buffer solutions
Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
Operate general production equipment (such as pH and conductivity meters, autoclaves, portable mixers, scales and balances, etc)
Monitor and record critical process parameters
Complete all relevant paperwork following GDP/GMP guidelines
Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
Perform sampling using aseptic techniques
Participate on Continuous Improvement Teams
Train and mentor other team members
Write, revise and review pertinent documentation as appropriate
Troubleshoot process problems and respond to process alarms
Assist with process/equipment validation and data analysis
Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion
Required to maintain attendance in accordance with the Bloomington Attendance Policy
Scheduled weekend overtime will be required