DescriptionAssociate Scientist, Manufacturing ScienceWe are seeking an
Associate Scientist to join our Manufacturing Science team and play a key role in developing and optimizing manufacturing processes that support new product development and successful transition into production. This role is ideal for an experienced scientific professional who can independently lead process development and scale-up activities, apply data-driven approaches to improve manufacturing capabilities, and collaborate across teams to ensure efficient, scalable, and compliant production processes.
This position is part of our Research & Development team in
St. Cloud, Minnesota, working closely with R&D scientists and Operations to support product development from early design through manufacturing implementation.
To Be Considered for This Position, Candidates Must Have the Following Qualifications:- Education: Bachelor's degree in Microbiology, Molecular Biology, Biochemistry, Chemical Engineering, Bioprocess Engineering, Biomedical Engineering, or a related field required. Master's degree preferred.
- Experience: 3+ years of industry experience in process development, scale-up, or technology transfer within a regulated industry, including IVD, diagnostics, medical devices, biologics, or pharmaceuticals.
- Demonstrated experience independently leading process development studies.
- Strong understanding of process validation, risk assessment, and design control principles.
- Advanced proficiency in statistical analysis and process optimization tools, including Design of Experiments (DOE), process capability analysis, and Six Sigma methodologies, using Minitab or similar software.
- Strong technical writing skills, including development of protocols, reports, and process documentation.
- Excellent problem-solving, communication, and project management skills, with the ability to work independently and influence cross-functional partners.
- Practical microbiology and/or molecular laboratory experience preferred.
- Experience with lyophilization and viral or molecular products preferred.
- Six Sigma Green Belt certification or equivalent preferred.
Why You'll Love This RoleAt Microbiologics, Manufacturing Science is more than process development. It's a critical connection between scientific innovation and successful manufacturing. In this role, you will:
- Lead process development and scale-up activities that help bring new products from early research into manufacturing.
- Apply your scientific expertise to develop scalable, repeatable, and cost-effective manufacturing processes.
- Partner closely with R&D scientists and Operations teams to influence product design and manufacturing readiness.
- Use statistical analysis, process optimization, and risk assessment to strengthen process performance and reliability.
- Serve as a technical resource and mentor within the Manufacturing Science team while contributing to continuous improvement of processes and standards.
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 DoProcess Development & Scale-Up- Independently lead process development and scale-up activities for new products, including designing and executing manufacturability and Design of Experiments (DOE) studies.
- Develop and optimize manufacturing processes from bench to pilot and production scale, ensuring scalability, process robustness, and cost effectiveness.
- Establish critical process parameters, operating ranges, process capability targets, and control strategies.
- Evaluate process technologies, equipment, and automation opportunities to support efficient manufacturing operations.
Manufacturing Readiness & Technology Transfer- Partner with R&D scientists throughout product development to provide design-for-manufacturability input and translate product designs into repeatable manufacturing processes.
- Support successful technology transfer by preparing comprehensive transfer documentation, specifications, materials, and processes for Operations.
- Lead equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Train Operations personnel during implementation and support post-transfer process stabilization and performance monitoring.
Process Validation & Data Analysis- Plan, develop, and execute process validation protocols and reports in accordance with applicable regulatory requirements.
- Analyze process data using statistical methods, including process capability analysis (Cp/Cpk), to identify trends, troubleshoot challenges, and improve performance.
- Identify and mitigate manufacturing risks through risk assessments and process Failure Mode and Effects Analysis (pFMEA).
- Maintain process risk documentation and apply scientific analysis to support process improvement decisions.
Technical Documentation & Cross-Functional Collaboration- Develop and maintain manufacturing documentation, including work instructions, batch records, equipment specifications, and process development reports.
- Collaborate with R&D scientists, Operations, and other cross-functional partners to support product development and manufacturing implementation.
- Contribute to Manufacturing Science standards, templates, and methodologies that support scale-up studies, capability assessments, and manufacturing readiness.
- Serve as a technical resource and mentor within the Manufacturing Science team.
Who Thrives HereWe believe strong Manufacturing Science professionals combine scientific expertise, critical thinking, and collaboration. This role is a strong fit for someone who:
- Enjoys solving complex technical challenges and improving manufacturing processes through scientific analysis.
- Demonstrates strong independent thinking, sound judgment, and attention to detail.
- Communicates technical information clearly and effectively across scientific and operational teams.
- Takes ownership of projects and can independently manage multiple priorities and timelines.
- Brings a collaborative mindset and enjoys sharing technical knowledge to support team success.
- 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 and office environment while following 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.
What We OfferWe 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
- $75,548.00 - $94,435.00 per year
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