Manufacturing Group Lead- Preparation; 2nd Shift

Company Overview

Simtra Bio Pharma Solutions (Simtra) is a contract development manufacturing organization partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre‑filled syringes, liquid/lyophilized vials, diluents, powder‑filled vials, and sterile crystallization.

Our product types include biologics, small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines—all directly injected into patients worldwide. We emphasize quality and continuous improvement, holding ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we provide many support services such as formulation and development, lyophilization optimization, global regulatory support, and secondary packaging to help clients scale and innovate.

• Make it HAPPEN – growth mindset, new skillsets, exceeding expectations.
• Make it TOGETHER – one team, respecting each voice, solving problems collaboratively.
• Make it RIGHT – high standard of excellence, fulfilling commitments to customers, patients, and teammates.
• Make it COUNT – day‑to‑day pride, impacting patient health, tackling challenges big and small.

Prep Group Lead – member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor. Provides direct support to manufacturing, ensuring finished products meet specifications by coordinating activities of Preparation Operators.

Schedule: Monday‑Thursday, 2:00 pm to 12:30 am

• Understand and follow current Good Manufacturing Practices.
• Assemble and operate filtration systems.
• Operate general production equipment (autoclaves, vial washers, de‑pyrogenation ovens, scales, 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 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 (maintenance, metrology, calibration) to ensure preventative maintenance completion.
• Maintain attendance in accordance with Bloomington Attendance Policy.
• Scheduled weekend overtime will be required.

Classified pharmaceutical environment including required gowning and personal protective equipment. Work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.

• 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.
• Experience operating multiple types of manufacturing equipment and hand‑operated devices (calipers, gauges, scales, measuring devices).

Occasional (0‑33%) – sitting, climbing stairs/ladders, balancing, stooping, kneeling, crouching, operating controls.

Lifting and carrying up to 52 lbs; pushing and pulling up to 22 lbs.

Frequent (34‑66%) – standing, walking, reaching forward and overhead; lifting and carrying up to 35 lbs; pushing and pulling up to 24 lbs.

Constant (67‑100%) – object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping.

• High school diploma or GED required.
• 6 months of previous pharmaceutical or manufacturing experience preferred.
• Must understand, speak, read and write English to comply with SOP, training materials, GMP manuals.
• Final candidates will be required to pass a post‑offer/pre‑employment job placement examination testing physical capabilities.