Senior Scientist , Analytical Development

LGC Axolabs is a business unit of LGC, and a leading provider of CRO / CDMO capability to the therapeutic oligonucleotide discovery and development industry. Centered out of LGC’s site in Kulmbach, Germany, Axolabs works closely with its customers to assist the identification and development of lead candidates with a broad suite of bioinformatics, biology, chemistry, manufacturing and analytical services that support discovery, pre-clinical and clinical trials and scale-up manufacture.

With a track record in Nucleic Acid Therapeutics that traces back more than 20 years, Axolabs provides deep knowledge and expertise in the services it provides, working collaboratively and responsively with its clients to assist them in achieving their objectives.

LGC Axolabs facility in Petaluma is focused on manufacturing scale-up and cGMP production of multigram to kilograms of API for pre-clinical and clinical development. Our California site has been experience in oligonucleotide synthesis over three decades and established the therapeutic manufacturing capability in 2018. With around 70 staff and two GMP manufacturing trains, Axolabs offers a flexible manufacturing service out of Petaluma that draws where necessary on our industry and chemical and analytical expertise in Kulmbach.

The Senior Scientist I, Analytical Development at LGC Axo Labs will serve as a subject matter expert (SME) in analytical method development and validation for oligonucleotide drug substances within a Contract Manufacturing Organization (CMO) environment. This role involves leading analytical initiatives, providing technical guidance to cross-functional teams, and engaging with clients to ensure the accurate characterization and in-process testing of oligonucleotide API and raw materials in compliance with regulatory standards.

LGC Axo Labs has an extensive, ever-evolving global client base and impressive technical capabilities within a state-of-the-art GMP facility. As the organization continues to grow, we seek technically adept and highly motivated candidates who can contribute to innovative solutions in oligonucleotide analytical development. The successful candidate will be detail-oriented, proficient in advanced analytical chemistry techniques, and experienced in oligonucleotide analysis. This role requires strong problem-solving skills, technical leadership, and direct interaction with clients to support their project needs.

Routine tasks include leading analytical HPLC method development, validation, and other analytical studies (e.g. forced degradation, MS/MS sequencing, stability) for custom oligonucleotide APIs and raw materials. The Senior Scientist I is responsible for managing multiple development projects, leading technical discussions, and facilitating fulfilment of project deliverables according to established timelines.

To perform this job successfully, an individual must be able to perform each essential function satisfactorily.

Essential Functions:

• Serve as a subject matter expert (SME) in analytical HPLC method development and validation for oligonucleotide APIs and raw materials.
• Independently design, execute, and interpret complex analytical studies, including forced degradation, MS/MS sequencing, and stability studies.
• Lead technical discussions with internal teams and clients to define analytical strategies, troubleshoot challenges, and drive project deliverables.
• Author and review technical documentation, including method development reports, validation protocols, Standard Operating Procedures (SOPs), and regulatory submission materials.
• Collaborate with cross-functional teams (e.g., Process Development, Quality Control, and Manufacturing) to integrate analytical solutions into oligonucleotide production workflows.
• Maintain working knowledge of relevant regulatory and pharmacopeia guidelines (FDA/ICH/USP) to ensure compliance across analytical activities.
• Provide mentorship and technical guidance to junior scientists, supporting skill development and scientific excellence…