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 teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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 companys 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:

• Bachelors degree required. Microbiology degree preferred
• Minimum of 7 years experience in a pharmaceutical QC role
• 3 years in a management role
• Experience with Validation/Sterility Assurance issues such as autoclave/dry heat oven validations biological indicators objectionable organism investigations/remediations and plant systems such as HEPA filtration and clean room design desirable
• Computer proficiency in Microsoft Word Excel and Outlook and the ability to use enterprise software (examples include: JDE
• BPLM Pilgrim Trackwise etc.)

Physical / Safety Requirements:

• Duties may require overtime work including nights and weekends.
• Position requires sitting for long hours but may involve walking or standing for periods of time.
• Use of hands and fingers to manipulate office equipment is required.
• Wear all PPE required by EHS (typically safety glasses lab coat gloves but may include a respirator).

In return youll be eligible for1:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

1 Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

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Senior Manager