Manufacturing Supervisor, 1st Shift

About the role

Simtra BioPharma Solutions is a world‑class Contract Development Manufacturing Organization partnering with pharma and biotech to bring sterile injectable products to market, with facilities in Bloomington, Indiana and Halle/Westfalen, Germany. They offer delivery systems such as pre‑filled syringes, liquid/lyophilized vials, diluents, powder‑filled vials and sterile crystallization for biologics, small molecules, cytotoxics, highly potent compounds and vaccines. Simtra emphasizes quality, continuous improvement, cGMP manufacturing and support services like formulation, lyophilization optimization, regulatory support and secondary packaging. Why join Team Simtra? Because they: Make it HAPPEN – growth mindset; Make it TOGETHER – collaborative; Make it RIGHT – high standards; Make it COUNT – pride in impact.

Responsibilities

• Understand, follow, coach, and lead teams to execute production activities per cGMP.
• Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
• Interview, hire, mentor, and develop staff; conduct annual performance reviews; assist in setting performance objectives and development plans.
• Supervise day‑to‑day production, scheduling, staffing, material management, compliance, training and auditing to meet customer requirements, deadlines and quality standards (high percentage of Gemba presence).
• Review, approve, and manage documentation for batch and system records; assist in product release for distribution and meeting release time goals.
• Implement and support training programs for strict cGMP and EHS compliance.
• Develop and implement performance measurement and internal auditing programs to evaluate operational efficiency and quality; implement changes as needed.
• Lead technical reviews, investigations and process improvement projects; provide manufacturing input into integration and validation of new equipment and processes.
• Resolve technical, material and cGMP problems that may impact project deadlines.
• Provide guidance and troubleshooting assistance during deviations, applying Root Cause Analysis (RCA) tools when applicable.
• Obtain qualification to perform select critical operation processes.
• Represent the company during audits and inspections.

Qualifications

Desirable qualifications:

• Bachelor’s degree in science, engineering, or business strongly preferred; high school diploma or GED required.
• Minimum 2 years of manufacturing or operations support experience strongly preferred.
• Minimum 1 year of leadership experience required.

Physical / safety requirements:

• Ability to stand or sit for extended periods.
• Ability to lift up to 50 pounds.
• Ability to push/pull heavy wheeled objects (tanks, carts, pallet jacks, etc.).
• Must be able to perform overhead work (sanitizing walls and ceilings).
• Physical coordination/flexibility to allow gowning for clean‑room environments.
• Use applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection.
• Dexterity and physical condition to perform some level of repetitive motion tasks.
• Ability to wear respirator when product or task requires.
• Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable).
• Use of hands and fingers to manipulate office equipment is required.
• Must be able to gown qualify for Grade A/B areas (filling).

Skills

Proficiency in Microsoft Word, Excel, Outlook, and enterprise systems such as Microsoft Dynamics, Veeva, PowerBI, or TrackWise.

Benefits

In return, you’ll be eligible for:

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program