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 teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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 Hand 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 guidancefeedbackandperformance 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 recordsandtraining curriculum

Required qualifications:

• HighSchooldiplomaorGEDrequired
• Minimum of 3 years experience in a training site start-upor 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 textaudioand video scripts
• ComputerproficiencyinMicrosoftWordExcelandOutlookandtheabilitytouseenterprisesoftware(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 abletoliftandcarryupto50lbspushand pull150 lbs.
• Extendedperiodsofstandingand/orwalking withextendedperiodsinGradeCDproductionenvironments
• 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 youll be eligible for1:

• 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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Manager