Manager, LNP Technical Operations

Danaher

  • Fargo, ND
  • Permanent
  • Full-time
  • 2 months ago
Bring more to life.Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?At Aldevron, one of 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 which makes everything possible.The LNP Manager of Technical Operations is responsible for overseeing all technical transfer programs involving Drug Product life cycles from from development through clinical and commercial applications.This position reports to the Sr Manager of RNA Technical Operations and is part of the Technical Operations Department located in Fargo, ND and will be an on-site role.In this role, you will have the opportunity to:
  • Coordinate department personnel onboarding processes and implement robust training plans.
  • Lead project planning and support department personnel with any questions and issues that arise during daily activities.
  • Review and approve new documents created by LNP Technical Operations department, including manufacturing batch records, SOPs, and all tech transfer documents.
  • Review technical transfer and process description documents in determining feasibility and scalability of incoming production unit operations.
  • Support Person-In-Plant (PIP) activities for newly developed or tech transferred manufacturing processes.
  • Lead cross-functional teams to support other departmental needs, including troubleshooting and manufacturing support.
  • Resolve quality issues and CAPA’s by assisting with lab investigations, conducting root cause analysis, and developing implementation plans.
The essential requirements of the job include:
  • BS degree in biology, molecular biology, biochemistry, chemistry, or related discipline with 5+ years of experience.
  • MS degree in biology, molecular biology, biochemistry, chemistry, or related discipline with 3+ years of experience.
  • PhD in biology, molecular biology, biochemistry, chemistry, or related discipline with 2+ years of experience.
  • Experience in leading multiple RNA/LNP technical transfer projects simultaneously through manufacturing, experimental design, and data analysis life cycles in a cGMP environment.
  • Advanced knowledge in biologics downstream bioprocessing.
It would be a plus if you also possess previous experience in:
  • General understanding of current USP and Regulatory guidelines to support all phases of Drug Product life cycles (e.g. Raw Material requirements, Retain management, Technical Writing, Audit Support, etc).
Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.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 .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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.

Danaher