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Senior Scientist I, Analytical Development
3 days ago
Company DescriptionLGC 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.Job DescriptionThe Senior Scientist I, Analytical Development at LGC AxoLabs 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 AxoLabs 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.QualificationsRoutine tasks include leading analytical HPLC method development, validation, and other analytical studies ( 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 (, 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 within the team.Other Skills and Abilities:Self-starter with strong problem-solving skills and the ability to work independently and collaboratively within cross-functional teams.Strong communication skills, both written and verbal, to effectively present data and collaborate with internal teams and external partners.Ability to manage multiple analytical projects simultaneously while maintaining attention to detail and deliverable timelines.Demonstrated commitment to scientific excellence and alignment with LGC’s core values and quality standards.Education/Experience: Bachelor’s degree in Chemistry, Biology, Biochemistry, or related discipline with 7+ years of applicable experience, or Master’s degree with 5+ years, or with 0–3 years of experience in a related field.Advanced technical understanding of oligonucleotide manufacturing processes and hands-on experience with relevant analytical techniques ( HPLC-MS, GC-FID, etc) and equipment.Working knowledge of chromatography and/or other software including ChemDraw, JMP, Empower, MassLynx, Chromeleon, and/or Waters Connect.Prior experience in a GMP-regulated environment within a CMO/CDMO or pharmaceutical manufacturing setting is strongly preferred.Additional InformationWhat we offer (US based-employees):Competitive compensation with strong bonus programComprehensive medical, dental, and vision benefits for employees and dependentsFSA/HSA Pre-tax savings plans for health care, childcare, and elder careDeductible Buffer Insurance and Critical Illness Insurance401(k) retirement plan with matching employer contributionCompany-paid short- and long- term disability, life insurance, and employee assistance programFlexible work optionsPet Insurance for our furry friendsEnhanced Parental leave of 8 additional weeksPTO that begins immediatelyTown Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Company wide social events, frequent catered lunches and much moreThe typical pay range for this exempt role is:Minimum: $ 93,750 /SalaryMaximum: $ 156,250 /SalaryThis range represents the low and high end of the anticipated salary range for the California -based position. The actual base salary will depend on several factors such as: experience, skills, and location.LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or maternity, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership
