Senior Manager, Manufacturing Training

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:

TheSenior Manager, Manufacturing Trainingis a key leadership role responsible for designing, implementing, and overseeing training programs that ensure manufacturing personnel are fully equipped to meet regulatory, quality, and operational standards. This role is ideal for a candidate with a strong background inregulated manufacturing environments and a solid foundation in instructional design, adult learning, or education. The successful candidate will be a strong people leader with experience setting goals, coaching employees, and fostering a safe learning environment. They will lead a team of Manufacturing Trainers and collaborate cross-functionally to foster a culture of continuous learning, compliance, and operational excellence. This role is critical in ensuring new employees can develop and deliver high quality injectables to our customers, so they can fulfill promises to patients with confidence.

The responsibilities:

• Lead and develop a team of Manufacturing Trainers to ensure consistent, effective training across all shifts and departments-includingPrep, Formulation, Filling, Capping, Packaging, and Inspection.
• Design and implement engaging training programs using adult learning principles and instructional design best practices.
• Oversee the creation and continuous improvement of training materials (SOPs, job aids, e-learning, classroom content).
• Partner with Manufacturing, Quality, and HR to align training with business goals and compliance requirements.
• Establish and track KPIs to measure training effectiveness and drive accountability.
• Ensure audit readiness and compliance with regulatory standards (FDA, EMA, etc.).
• Champion digital learning tools and Learning Management Systems (LMS) for training delivery and tracking.
• Support employee development through structured learning pathways and competency-based training.
• Manage training budgets, resources, and vendor relationships.

The work environment:

• Ability to work in cleanroom environments and wear appropriate PPE.
• Occasional lifting (up to 25 lbs), standing, and walking in manufacturing areas.
• Flexibility to support multiple shifts and occasional weekend or evening work.

Required qualifications:

• Bachelor's or Master's degree in Education, Instructional Design, Organizational Development, or a related field.
  (Degrees in Life Sciences or Engineering with strong training experience will also be considered.)
• 5+ years of experience in a regulated manufacturing environment (pharma, biotech, or similar).
• 3+ years of leadership experience managing teams and training programs.
• Expertise in adult learning theory, instructional design, and training evaluation.
• Strong knowledge of GMP, GDP, and regulatory compliance.
• Excellent communication, facilitation, and project management skills.
• Proficiency in Microsoft Office and enterprise systems (LMS, JDE, Trackwise, Veeva, Dynamics 365).

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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