Microbiology Manager

Microbiology Manager

Bloomington, Indiana, United States

Simtra Bio Pharma 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  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.

The role:

The Quality Laboratory Manager leads the Microbiology Department with regard to all regulatory requirements, while driving quality improvements of products and processes through active participation in inter-departmental areas. They are responsible for Good Manufacturing Practices (GMP) compliance and adherence to Corporate Quality Policy Standard Operating Procedure's (SOP) within the area. This position manages technicians and analysts and reports to the Manager II, Quality.

The responsibilities:

• Oversee the company's environmental monitoring 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.
• 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.
• 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
• Author and review EMPQ, studies, change control, laboratory investigations, and continuous improvement.
• Perform metrics and present to management.
• Participate in regulatory and client audits as Subject Matter Expert

The requirements:

• Bachelor's degree in a physical science require. Microbiology highly desired.
• Minimum of 5 years experience, with at least 2 years in a supervisory or management role
• Experience working in the QC Microbiology Laboratory supporting a pharmaceutical manufacturing facility.
• Experience with out-of-level/objectionable organism investigations/remediations;
  Experience with plant systems such as HEPA filtration and clean room design desirable.
• Computer proficiency in Microsoft Office, Outlook, LIMS and the ability to use enterprise software (examples include: 365, Veeva.)

Physical / Safety Requirements:

• Duties may require overtime work, including nights and weekends.
• Position…