Process Specialist - Clinical Manufacturing

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 Process Specialist - Clinical Manufacturing plays a critical role in supporting the daily operations of the clinical production area. This includes training, equipment operation, and team leadership oversight. As a Subject Matter Expert (SME), you will provide direct technical and process support for clinical manufacturing lines and assist in the successful transfer of products into production.

This position serves as a management designee based on production needs and requires strong cross-functional collaboration with departments such as DPCS, Quality, Engineering, Maintenance, Technical Services, and client teams.

The responsibilities:

• Develop expertise in filling line processes and equipment, including syringe and vial handling, filling, stoppering, capping, and tray loading.
• Become SME across multiple manufacturing areas: Preparation, Filling, Formulation, Capping, and Lyophilization.
• Delegate and coordinate scheduled activities and team members; spend 80% of time in-room/on the floor.
• Collaborate closely with Quality and ensure compliance and operational flexibility.
• Support product technical transfers into the Clinical production area.
• Assist in developing and reviewing batch records for new and existing projects.
• Monitor documentation in logbooks and batch records.
• Partner with EHS to uphold safety and sustainability standards.
• Apply Lean/Six Sigma tools to drive process improvements and foster a culture of continuous improvement.
• Lead or participate in investigations to resolve complex issues and implement corrective actions.
• Analyze process trends to identify improvement opportunities in equipment, efficiency, and yield.
• Standardize and train on set-up and troubleshooting procedures.
• Coach and mentor Production Operators on specialized tasks.
• Maintain Grade A/B aseptic gowning certification and successful media fill performance.

The work environment:

• Ability to lift up to 50 lbs.
• Willingness to work overtime, including nights and weekends.
• Extended periods of standing, walking, and working in Grade A-D environments.
• Manual dexterity for equipment manipulation.
• Ability to wear a respirator or PAPR.

Required qualifications:

• Bachelor's Degree or equivalent experience preferred.
• Minimum 5 years of experience in pharmaceutical manufacturing or technical support.
• Strong understanding of Good Manufacturing Practices (GMP).
• Experience with process equipment or onboarding preferred.
• Proficiency in Microsoft Word, Excel, Outlook, and enterprise systems (e.g., Maximo, Trackwise, Veeva).
• Ability to work effectively in hands-on environments, including Grade C/D classified areas.

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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