Manufacturing Supervisor
3 days ago
Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring sterile injectable products to market. Our facilities in Bloomington, Indiana, and Halle/Westfalen, Germany, offer a wide range of delivery systems, including pre-filled syringes, liquid/lyophilized vials, and more.
About the RoleThe Manufacturing Supervisor is a key member of our Manufacturing Leadership Team, reporting directly to the Manufacturing Manager. This role provides direct support to Manufacturing personnel and is engaged in the production of injectable drug products. The successful candidate will ensure compliance with all standard operating procedures and batch records, communicating effectively with manufacturing support departments and multiple levels of management.
Responsibilities- Understand and follow current Good Manufacturing Practices
- Provide guidance, support, direction, and leadership to all personnel during daily operations
- Interview, hire, mentor, and develop staff, conducting annual performance reviews and setting performance objectives and development plans
- Supervise day-to-day production, scheduling, staffing, material management, compliance, training, and auditing activities to meet customer requirements
- Review, approve, and manage documentation for batch and system records, assisting in the release of product for distribution
- Implement and support training programs to enable staff to consistently carry out manufacturing processes with strict compliance to cGMPs and EHS regulations
- Develop and implement performance measurement and internal auditing programs to evaluate operation efficiency and quality
- Lead technical reviews, investigations, and process improvement projects, providing manufacturing input into integration and validation of new equipment and processes
- Resolve technical, material, and cGMP problems that may impact project deadlines
- High School diploma or GED required; Bachelor's Degree strongly preferred
- Minimum 2 years of manufacturing experience required; minimum 1 year leadership experience required
- Computer proficiency in Microsoft Word, Excel, and Outlook, and the ability to use enterprise software
- Ability to stand or sit for extended periods, lift up to 50 pounds, and perform overhead work
- Must be able to gown qualify for Grade A/B areas (filling)
Simtra BioPharma Solutions offers a comprehensive benefits package, including medical and dental coverage, flexible spending accounts, life and AD&D insurance, and 401(k) retirement savings plan with company match. We also offer paid time off, paid holidays, and paid parental leave, as well as education assistance and employee assistance programs.
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