Jobs · Analyst · Minnesota

Manufacturing Science Associate

Microbiologics · St Cloud, MN · 1 mo ago
AnalystFull-time

About the Role

Manufacturing Science plays an important role in connecting product development with successful manufacturing implementation. This role supports the development and transfer of new products from product design into controlled, scalable, and repeatable manufacturing processes. It applies knowledge of design controls, technology transfer, process validation, and manufacturing readiness to ensure that product designs can be effectively manufactured and transferred into routine operations.

What You'll Do

  • Support design control activities associated with new product development and transfer, including review of design requirements, manufacturing considerations, design outputs, and transfer documentation
  • Plan and support the transfer of new and revised product designs into manufacturing, including transfer planning, identification of requirements, coordination of activities, and assessment of manufacturing readiness
  • Participate in cross-functional design and transfer readiness reviews to assess manufacturability, identify gaps and risks, and support manufacturing implementation decisions
  • Develop, review, and maintain manufacturing documentation, including work instructions, training materials, transfer documentation, and other technical documents needed for operational readiness
  • Plan, execute, and document process validations and transfer activities in accordance with applicable quality and regulatory requirements
  • Evaluate manufacturing processes and product requirements using data and risk-based approaches to identify process risks, establish appropriate controls, and support successful transfer
  • Ensure traceability and completeness of technical transfer deliverables and support timely completion of activities required for project milestones and manufacturing readiness
  • Perform laboratory or manufacturing activities supporting technology transfer, process development, training, and validation activities
  • Provide production and technical support for new, transferred, or customer-specific products requiring specialized capabilities
  • Compile, analyze, and communicate data to provide insights and recommendations supporting design, transfer, validation, and manufacturing readiness decisions
  • Collaborate with cross-functional teams to align objectives, timelines, and successful project execution
  • Maintain compliance with applicable regulations, company policies, and industry standards

Required Qualifications

  • Bachelor's degree in engineering, life sciences, biology, microbiology, molecular biology, or a related field
  • Minimum of 2–3 years of experience working in a regulated product development, manufacturing, quality, or engineering environment
  • Previous experience with design controls in a regulated product development environment
  • Previous experience supporting technology transfer, design transfer, or the transfer of products/processes into manufacturing
  • Experience developing, reviewing, or maintaining controlled technical documentation
  • Strong technical writing skills with experience drafting procedures and technical reports preferred
  • Experience with process validation, manufacturing readiness, risk assessment, or process development and technology transfer in a regulated manufacturing environment preferred
  • Laboratory or hands-on manufacturing experience preferred

Who Thrives Here

We believe strong Manufacturing Science professionals combine technical knowledge with curiosity, collaboration, and attention to detail. This role is a strong fit for someone who:

  • Demonstrates strong technical writing and documentation skills
  • Can manage multiple priorities while maintaining strong organization and time management
  • Uses good judgment and sound decision-making skills
  • Brings strong independent and critical thinking skills to their work
  • Is resourceful, self-motivated, and approaches problems with attention to detail
  • Communicates effectively and works collaboratively in a team environment
  • Aligns with our values by working collaboratively, striving for excellence, bringing forward ideas with confidence, and demonstrating care for others

Additional Requirements

  • Ability to pass a background check and drug screening
  • Ability to work in a laboratory environment and follow required safety practices and PPE requirements
  • Ability to occasionally lift and move up to 25 pounds to shoulder height unaccompanied
  • Ability to work directly with Risk Group I and Risk Group II bacteria, yeast, and fungi
  • Ability to pass a color blindness test

Benefits

  • Medical and dental insurance
  • Company-funded Health Savings Account (HSA)
  • Life insurance and disability coverage
  • 401(k) with company match
  • Tuition reimbursement and professional development
  • Bonus potential
  • A collaborative, team-oriented culture focused on growth

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