Senior Manager, Aseptic Operations

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:

We are seeking a dynamic and experienced Sr. Manager of Aseptic Operations to join our leadership team in Bloomington, Indiana. This individual will lead and manage all aseptic manufacturing activities within their assigned Aseptic Operations Cell, playing a key role in executing the site's strategic manufacturing objectives. As a critical member of the Cell Leadership Team, the Sr. Manager will collaborate closely with Quality, Engineering & Maintenance, and Technical Services counterparts to ensure the highest standards of cGMP compliance, safety, and operational excellence.

The responsibilities:

• Lead the execution of manufacturing plans to ensure Right First Time and On Time Delivery KPIs are met.
• Champion a culture of safety, continuous improvement, and lean manufacturing principles (6S).
• Develop and lead a high-performing operations team by hiring, coaching, and setting clear performance expectations.
• Foster strong cross-functional relationships with Quality, Engineering, Technical Services, and Program Management teams.
• Review, approve, and drive timely closure of deviations, SOPs, protocols, and validations.
• Represent the Aseptic Operations Cell during client engagements and audits.
• Manage department budgets and ensure performance meets business objectives.
• Drive a customer-focused mindset, ensuring product value and quality are consistently delivered.

Required qualifications:

• Bachelor's degree in a scientific or engineering discipline required.
• Minimum 8 years of experience in aseptic manufacturing within a regulated pharmaceutical environment.
• At least 5 years in a leadership role, with demonstrated experience managing teams in a cGMP setting.
• Strong knowledge of GMP regulations and international regulatory agency requirements.
• Proficiency in Microsoft Office and enterprise systems (e.g., JDE, BPLM, Pilgrim, Trackwise).

Physical / safety requirements:

• Ability to stand for extended periods and perform repetitive tasks.
• Must be able to gown for Grade A/B cleanroom environments.
• Use of PPE, including respirators, is required for certain tasks.
• May require overtime, including nights and weekends.

In return, you'll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long-Term Disability 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
  • 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 12/31/25

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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