Manufacturing Senior Supervisor

3 days ago

Bloomington, Indiana, United States Simtra BioPharma Solutions Full time
About Simtra BioPharma Solutions

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) that partners with pharmaceutical and biotech companies to bring 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 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.

Job Summary

We are seeking a Senior Supervisor, Manufacturing to join our team. The successful candidate will be responsible for providing direct support to manufacturing personnel and ensuring compliance with all standard operating procedures and batch records. The Senior Supervisor, Manufacturing will provide decision-making and oversight to ensure the production of high-quality injectable drug products.

Key Responsibilities
  • Understand and follow current Good Manufacturing Practices (cGMPs)
  • Provide guidance, support, direction, and leadership to manufacturing personnel during daily operations
  • Interview, hire, mentor, and develop staff
  • Conduct annual performance reviews for direct reports
  • Supervise day-to-day production, scheduling, staffing, material management, compliance, training, and auditing activities
  • Review, approve, and manage documentation for batch and system records
  • Assist 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
  • Provide manufacturing input into integration and validation of new equipment and processes
  • Resolve technical, material, and cGMP problems that may impact project deadlines
Requirements
  • HS Diploma/GED required; Bachelor's degree preferred
  • Minimum 3 years of manufacturing experience required
  • Minimum 4 years of leadership-related experience required
  • In-depth knowledge of related pharmaceutical manufacturing equipment and processes preferred
  • Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry preferred
  • Computer proficiency in Microsoft Word, Excel, and Outlook, and the ability to use enterprise software (e.g., JDE, BPLM, Maximo, Trackwise, Microsoft Dynamics, etc.)
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 (e.g., tanks, carts, pallet jacks, etc.)
  • Must be able to perform overhead work (e.g., 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 usage 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)

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