Operational Readiness Manager

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 Operations Readiness Manager serves as a key member of the Manufacturing Leadership Team, reporting to the Building Director. This role is responsible for designing and leading a strategic, fully integrated learning and readiness program that supports the operational success. The position provides leadership and development for manufacturing trainers, partners closely with Learning & Development to ensure a seamless transition from initial onboarding, and supports the ongoing growth of manufacturing personnel.

This role ensures Good Manufacturing Practices (GMP), core competencies, regulatory compliance, and adherence to Simtra Standard Operating Procedures. The Operations Readiness Manager drives quality performance on the production floor and collaborates effectively with production teams, crossfunctional partners, and multiple levels of leadership.

Ideal candidates bring expertise in curriculum design, process and procedure development, and adult learning methodologies. Strong communication, team leadership, computer proficiency, and the ability to manage multiple projects simultaneously are essential.

The responsibilities:

• Develop trainingcurriculumin collaboration with stakeholders to support Manufacturing performance objectives
• Support thecreation andrevisionof SOPspertaining tooperations.
• Create and deliver training content for production personnel and applicable support groups.
• Develop and oversee production training structure, Building H,and training plans and implement evaluations and metrics to assess effectiveness of training programs against production goals
• Define and direct the work ofdedicatedBuilding Htrainingteammembersby setting clear expectations and providing guidance,feedback,andperformance evaluations.
• Develop agradingrubricfor operators toassesscompetency
• Develop career ladders, specific to Building H, for progression of operator levels
• Participate and promote subordinate participation on cross-functional and process improvement teams
• Participate in Manufacturingtraining batchesandintegrateimprovements intoSOPs, batch records,andtraining curriculum

Required qualifications:

• HighSchooldiplomaorGEDrequired
• Minimum of 3 years' experience in a training, site start-up,or leadership capacity
• 1-3yearsofpharmaceuticalmanufacturingexperiencerequired.
• Experience developing effective and comprehensive adult learning programs
• Demonstrates a positive, proactive approach to problem solving and impediments, mentors' others to understand and model this approach
• Ability to provide effective group and individual training
• Experience with technical writing
• Instructional design skills with ability to write effective materials, instructional text,audioand video scripts
• ComputerproficiencyinMicrosoftWord,Excel,andOutlookandtheabilitytouseenterprisesoftware(examples include:Veeva, D365, Blue Mountain, etc.)
• Knowledge of cGMP and GDP practicesand regulatoryrequirements
• Proficiencyin a variety of mathematical disciplines and ability to work with both the metric and USA standards of measurementrequired.

Physical / safety requirements:

• Mustbe abletoliftandcarryupto50lbs,pushand pull150 lbs.
• Extendedperiodsofstandingand/orwalking, withextendedperiodsinGradeC,Dproductionenvironments
• Useofhandsandfingerstomanipulateequipmentisrequired
• Physical coordination/flexibility to allow gowning for clean room environments
• Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
• Dexterity and physical condition to perform some level of repetitive motion tasks

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
    
    
    
    
  • 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 12/31/26

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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