Sr. Manager, Aseptic Operations

Simtra Bio Pharma Solutions (Simtra) is a world‑class contract development manufacturing organization 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 pre‑filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder‑filled vials, and sterile crystallization.

Our product portfolio spans biologics, small molecules, cytotoxics, highly potent compounds, diluents, and vaccines. Quality and continuous improvement are central to every stage of development and manufacturing, upholding the highest regulatory standards.

• Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skill sets and exceeding expectations.
• Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams to solve problems in new ways.
• Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to customers, patients, and team members.
• Make it COUNT – We take pride in our day‑to‑day work, taking on challenges big and small to improve patient health.

The Sr. Manager of Aseptic Operations leads all activities within the Aseptic Operations Cell at our Bloomington site, reports to the Director of Aseptic Operations, and is part of the Cell Leadership Team. The role sets strategic direction, manages personnel and processes, and ensures consistent execution and continuous improvement under cGMP regulations.

• Accountable for successful execution of the manufacturing plan to deliver on the site’s two primary KPIs:
  Right First Time and On Time Delivery.
• Creates and sustains a culture of safety, adhering to all environmental, health, and safety SOPs.
• Leads by example, inspiring trust and integrity across subordinates, peers, and superiors.
• Instills lean principles and 6S practices to drive continuous improvement.
• Aligns actions to deliver customer value and leads the team to achieve strategic objectives.
• Handles hiring, coaching, and performance feedback for staff.
• Partners with Quality, Technical Services, Engineering & Maintenance to review deviations, approve SOPs, and close client audits timely.
• Provides technical expertise across cross‑functional teams and manages the annual operating budget.
• Reports regularly to senior leadership on performance against business plans.
• Ensures quality commitments are met through collaboration with other manufacturing operations staff.

• Bachelor’s degree required.
• Minimum 8 years of experience in aseptic manufacturing processes preferred.
• Knowledge of GMPs and worldwide regulatory agency guidelines.
• At least 5 years in a leadership role.
• Proficiency in Microsoft Office and enterprise software (e.g., JDE, BPLM, Pilgrim).

• Ability to stand for extended periods and perform repetitive motions.
• Physical coordination for clean room gowning, respirator use when required, and use of PPE.
• May require overtime, nights, or weekends.
• Requires active hand/finger dexterity for office equipment manipulation.
• Must meet cleaning qualification for Grade A/B areas.
• May sit for long periods.

• 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.

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.

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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