Manufacturing Supervisor, Formulation/Preparation (3rd Shift)

Job Description

Simtra BioPharma Solutions is seeking a Manufacturing Supervisor for its Bloomington, Indiana facility. This role is a member of the Manufacturing Leadership Team and reports to the Manufacturing Manager. The Supervisor provides direct support to Manufacturing personnel engaged in the production of injectable drug products, ensuring compliance with standard operating procedures and batch records. They will communicate with various departments and levels of management, fostering a culture of partnership, productivity, safety, identity, strength, purity, and quality.Simtra BioPharma Solutions is committed to quality and continuous improvement, adhering to the highest regulatory standards. The company offers various support services, including formulation and development, lyophilization optimization, global regulatory support, and secondary packaging.Responsibilities:

• Provide guidance, support, and leadership to manufacturing personnel.
• Interview, hire, mentor, and develop staff.
• Supervise day-to-day production, scheduling, staffing, and material management.
• Review and manage documentation for batch and system records.
• Assist in product release and meeting release time goals.
• Implement and support training programs.
• Develop and implement performance measurement and internal auditing programs.
• Lead technical reviews, investigations, and process improvement projects.
• Provide manufacturing input into equipment integration and validation.
• Resolve technical, material, and cGMP problems.
• Represent the company during audits and inspections.

Requirements:

• High School diploma or GED required; Bachelor's Degree strongly preferred.
• Minimum 2 years of manufacturing experience required.
• Minimum 1 year of leadership experience required.
• Computer proficiency in Microsoft Word, Excel, and Outlook.
• Ability to use enterprise software (JDE, BPLM, Maximo, Trackwise, Microsoft Dynamics, etc.).
• Ability to stand or sit for extended periods.
• Ability to lift up to 50 pounds.
• Ability to push/pull heavy wheeled objects.
• Ability to perform overhead work.
• Physical coordination/flexibility for clean room gowning.
• Use of personal protective equipment.
• Dexterity for repetitive motion tasks.
• Eyesight for equipment inspection.

Simtra BioPharma Solutions offers:

• Day One Benefits (Medical & Dental Coverage, Flexible Spending Accounts, Life and AD&D Insurance, 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
• Voluntary Insurance Benefits (Vision, Accident, Critical Illness, etc.)
• Onsite Campus Amenities (Workout Facility, Cafeteria, Credit Union)