Engineer II, LNP Process Development

Posted 19 Days Ago
Be an Early Applicant
Fargo, ND
In-Office
Mid level
Biotech
The Role
Lead LNP drug product process development and technology transfer from late-stage development through clinical and commercial manufacture. Drive process design, scale-up, optimization, GMP support, troubleshooting during campaigns, and provide technical input for equipment fit, studies, and client interactions while mentoring junior staff.
Summary Generated by Built In

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?  

 

At Aldevron, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.   

 

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. 

 

At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team, you’ll help bring life-changing innovations to life—impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you're launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potential—one discovery at a time. 

 

Learn about the Danaher Business System which makes everything possible. 

 

The Engineer II, LNP Process Development leads technology transfer activities across Drug Substance and Drug Product life cycles—from late‑stage process development through clinical and commercial manufacturing. This role drives process design, scaleup, and optimization with a focus on LNP Drug Product delivery systems. The position applies strong technical skills and independent problemsolving to help ensure manufacturing processes are robust, efficient, and compliant for both internal development programs and external client transfers. 

 

This position reports to the Manager of LNP Technical Operations and is part of the Technical Operations Department located in Fargo, ND. This is an on-site role. 

 

In this role, you will have the opportunity to: 

  • Drive technical activities that support robust, compliant processes aligned with client expectations and regulatory requirements. 

  • Execute and help shape process design, evaluation, and optimization work for LNP‑based Drug Product processes, including technical documentation, equipment fit assessments, and execution of studies that support scalable and reliable GMP operations. 

  • Provide hands‑on technical support during manufacturing campaigns, assisting with troubleshooting, deviation management, and crossfunctional alignment to maintain strong process understanding through final product release. 

  • Develop growing subject‑matter expertise in LNP formulation science, process development, and technology transfer, and provide clear, dependable technical input during client discussions and internal reviews.  Inform technical and operational decisions by contributing datadriven insights to evaluations of new technologies, capital investments, and process improvements. 

  • Support development of junior team members by sharing technical learnings, participating in cross‑functional efforts, and promoting best practices in scientific and operational execution. 

 

The essential requirements of the job include:  

  • BS degree in Chemical Engineering, Bioengineering, Chemistry, or a related field with 4+ years of relevant industry experience in biopharma, drug product development, or LNP/mRNA‑based manufacturing, supporting process development, scale‑up, or GMP technical operations. OR 

  • MS degree in a relevant scientific or engineering discipline with 2+ years of experience supporting process development, scale‑up, or GMP technical operations. OR 

  • PhD in a related field with 1+ year of hands‑on experience in LNP formulation, RNA therapeutics, or parenteral drug product manufacturing. 

  • Foundational experience with LNP formulation, microfluidics‑based mixing, and technology transfer, including involvement in GMP batch support, process troubleshooting, deviation investigations, or data analysis. 

  • Effective cross‑functional communication and collaboration skills, including partnering with Manufacturing, QA, QC, MSAT, and clientfacing teams, preparing technical documentation, presenting data, and supporting datadriven decisions and continuous improvement. 

 

It would be a plus if you also possess previous experience in: 

  • Supporting mRNA or LNP development and scale‑up activities, including exposure to CMC expectations or regulatoryrelevant documentation. 

  • Working with formulation or microfluidic mixing systems and helping adapt or troubleshoot these platforms during process development or tech transfer. 

  • Performing or interpreting routine analytical characterization to assess LNP or drug product quality and contribute to data‑driven process decisions. 

#LI-LM3

 

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [email protected].

Top Skills

Lnp Formulation,Microfluidics-Based Mixing,Microfluidic Mixing Systems,Gmp,Cmc,Mrna Therapeutics,Analytical Characterization
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The Company
HQ: Sunnyvale, CA
4,883 Employees
Year Founded: 1996

What We Do

Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid’s broad test portfolio spans respiratory infections, blood virology, women’s and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company’s solutions deliver actionable results where they are needed most – from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.

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