Operational Readiness Manager

Simtra Bio Pharma 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  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.

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.

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, cross functional 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.

• Develop trainingcurriculumin collaboration with stakeholders to support Manufacturing performance objectives
• Support the creation andrevisionof SOPspertaining to operations.
• 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 of dedicated
  
  Building Htrainingteammembersby setting clear expectations and providing guidance,feedback,and performance 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 Manufacturing training batchesandintegrateimprovements into
  
  SOPs, batch records,and training curriculum

• 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
• Computerproficiencyin Microsoft Word ,Excel,and Outlookandtheabilitytouseenterprisesoftware(examples include:
  
  Veeva, D365, Blue Mountain, etc.)
• Knowledge of cGMP and GDP practices and regulatory requirements
• Proficiency in a variety of mathematical disciplines and ability to work with both the metric and USA standards of measurement required.

• Mustbe abletoliftandcarryupto
  50lbs,pushand pull
  150 lbs.
• Extendedperiodsofstandingand/orwalking, withextendedperiodsin
  
  Grade
  
  C,Dproductionenvironments
• Useofhandsandfingerstomanipulateequipmentisrequired
• Physical…