Manufacturing Group Lead- Formulation; 2nd Shift

Manufacturing Group Lead
- Formulation (2nd Shift)

Simtra Bio Pharma Solutions (Simtra) is a world‑class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre‑filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder‑filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.

As such, there is a strong emphasis on quality and continuous improvement  hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimisation, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life‑changing medicines to patients worldwide.

• Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
• Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.
• Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
• Make it COUNT – We take pride in our day‑to‑day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The Formulation Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor. They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Formulation Operators who perform in the manufacturing areas. The Formulation Group Leader provides decision‑making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.

This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments. The Formulation Group Leader creates 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 10:00pm‑8:30am (4/10hr days).

• 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

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions. Must be able to occasionally (1‑33% of the time) work in a confined/clustered work space.

• Ability to work independently
• Good communication skills
• Good documentation skills,…