Manufacturing Science Associate

Microbiologics; Saint Cloud (MN); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

HSA (Health Savings Account)

Life insurance

401(k) match

Tuition reimbursement

Professional development

Bonus potential

Job summary

Microbiologics in Minnesota seeks a Manufacturing Science Associate to bridge product design with scalable, repeatable manufacturing processes. You will contribute to design controls, technology transfer, and validation activities, using data-driven and risk-based approaches to guide manufacturing readiness across cross-functional teams.

The role emphasizes technical writing, documentation, and collaboration to ensure seamless product transfers from development to routine production, in a

Qualifications

• Bachelor's degree in engineering, life sciences, biology, microbiology, molecular biology, or related field.
• Minimum 2–3 years in a regulated product development, manufacturing, quality, or engineering environment.
• Experience with design controls in a regulated product development environment.
• Experience supporting technology transfer or transfer of products into manufacturing.
• Experience developing, reviewing, or maintaining controlled technical documentation.

Responsibilities

• Support the transfer of new and revised products into manufacturing.
• Contribute to design control, technology transfer, process validation, and manufacturing readiness activities.
• Use data and risk-based approaches to identify process risks and support decisions.
• Collaborate across cross-functional teams for timelines and project execution.
• Apply scientific knowledge to technical challenges and continuous improvement.

Skills

Technical writing

Data analysis

Risk assessment

Cross-functional

Education

Bachelor's degree in engineering or life sciences

Tools

Documentation tools

Job description

Brief Description

Manufacturing Science Associate

At Microbiologics, our impact goes far beyond the lab. As a global biotechnology company with a strong reputation for quality, collaboration, and scientific rigor, we support the health and safety of people around the world through trusted biological products and services.

Everything we do is grounded in our core values: We Win Together, Driven to Achieve, Brave, Bold and Confident, and We Care, which guide how we work, make decisions, and support one another.

We are seeking a Manufacturing Science Associate to support the development and transfer of new products from product design into controlled, scalable, and repeatable manufacturing processes. This role 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.

To Be Considered for This Position, Candidates Must Have the Following Qualifications:

• Education: Bachelor's degree in engineering, life sciences, biology, microbiology, molecular biology, or a related field
• Experience: 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

Why You'll Love This Role

At Microbiologics, Manufacturing Science plays an important role in connecting product development with successful manufacturing implementation. In this role, you will:

• Support the transfer of new and revised products into manufacturing
• Contribute to design control, technology transfer, process validation, and manufacturing readiness activities
• Use data and risk-based approaches to help identify process risks and support manufacturing decisions
• Collaborate across functional teams to align objectives, timelines, and project execution
• Apply scientific knowledge and best practices to technical challenges and continuous improvement

You'll have the opportunity to make a meaningful impact while working in an environment where our values show up in everyday decisions whether that's collaborating to win together, pushing to achieve more, stepping forward with bold ideas, or showing care for our colleagues and customers.

What You'll Do

Design & Technology Transfer

• 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

Manufacturing Readiness & Validation

• 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

Testing & Technical Support

• 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

Data & Cross-Functional Collaboration

• 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

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

Who We Are

Microbiologics is a global biotechnology company and trusted partner to healthcare and life science organizations worldwide. For more than 50 years, we have supported laboratories, manufacturers, and suppliers with high‑quality biological control materials, assay services, and consulting.

Headquartered in St. Cloud, Minnesota, with additional facilities across the United States and in Rostock, Germany, we are driven by how we work as much as what we deliver. We win together through collaboration, push ourselves to achieve more, bring forward ideas with confidence, and care deeply about the people we serve and the colleagues we work alongside. These values shape our culture and guide how we support our customers and each other every day.

What We Offer

We offer a comprehensive and competitive benefits package, including:

• 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