Simtra BioPharma Solutions · 10 hours ago
Operational Readiness Manager
Bloomington, Indiana, United States
Full-time
Onsite
Mid Level
3+ years expSimtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies. The Operations Readiness Manager is responsible for designing and leading a strategic learning and readiness program to support operational success and ensures adherence to Good Manufacturing Practices and regulatory compliance.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Develop training curriculum in collaboration with stakeholders to support Manufacturing performance objectives
Support the creation and revision of SOPs pertaining 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 H training team members by setting clear expectations and providing guidance, feedback, and performance evaluations
Develop a grading rubric for operators to assess competency
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 batches and integrate improvements into SOPs, batch records, and training curriculum
Qualification
Required
High School diploma or GED required
Minimum of 3 years' experience in a training, site start-up, or leadership capacity
1-3 years of pharmaceutical manufacturing experience required
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, audio and video scripts
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (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
Must be able to lift and carry up to 50 lbs, push and pull 150 lbs
Extended periods of standing and/or walking, with extended periods in Grade C, D production environments
Use of hands and fingers to manipulate equipment is required
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
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
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
Company
Simtra BioPharma Solutions
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$0.5M2024-12-19Grant· $0.5M
Leadership Team
M
Mike Schaefers
Chief Commercial Officer (CCO) & Head of Business Development
Recent News
2026-01-22
2026-01-20
Company data provided by crunchbase