Senior Manager, Microbiology

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US 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. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Why join Team Simtra? Because we: Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health. This role: The Senior Manager, Microbiology is responsible for leading microbiology laboratory operations, ensuring the quality, safety, and compliance of microbiological testing programs. This role provides strategic and technical leadership for environmental monitoring, microbial identification, sterility assurance, and method validation activities while maintaining adherence to regulatory requirements and industry standards. The Senior Manager oversees laboratory personnel, drives continuous improvement initiatives, supports audits and inspections, and collaborates cross-functionally with Quality, Manufacturing, R&D, and Regulatory teams to ensure product quality and business objectives are achieved. Strong leadership, microbiological expertise, and experience in regulated environments are essential for success in this role. The responsibilities: Manage the microbiological testing and disposition of finished product, in-process, stability testing, validation, and raw material samples. Oversee the company’s environmental monitoring, sterility testing, and critical utilities monitoring program in all GMP aspects. Responsible for the evaluation of manufacturing environment against international standards of operation. Evaluation of test methods against current USP and industry regulatory standards. Review and approve reports, investigations, validations required by company. Ensure GMP compliance of all functions and processes of the laboratory and for continuous improvement. Coordination and evaluation of media fills. Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans. Ensure resource availability to adequately support Manufacturing operations. Develop and adhere to department budget. Implement quality systems to reduce product testing time and increase timely response to customer requirements. Prepare, review and implement SOPs and verify documents required Assist clients with interpretation of results and facilitate their understanding of testing and data. Conduct training in lab quality assurance procedures Participate in regulatory and client audits as Subject Matter Expert Required qualifications: Ba…