Technical Reviewer- Quality Control/CMC Analytical

Company Description

Axolabs is a business unit of LGC, and a leading provider of CRO / CDMO capability to the therapeutic oligonucleotide discovery and development industry. Centred 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. 

Axolabs facility in Petaluma is focused on manufacturing scale-up and production to cGMP of multigram to kilograms of API for pre-clinical and clinical development. Our site in California has been involved in oligonucleotide synthesis for three decades and established the therapeutics activity in 2019. With around 70 staff and two 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 Description

The Technical Reviewer in LGC AxoLabs Quality Control is a dual role with no less than 70% focus on reviewer and document generation responsibilities. The remaining time will be spent in support of analytical testing in the laboratory. This role will be responsible for reviewing documents and source data to ensure accuracy, completeness and integrity following the principles of ALCOA+. This role involves review and generation of testing, reporting, and investigation data and documentation working with cross-functional teams to ensure accurate and timely support of in-process, release and stability testing of oligonucleotide API and raw materials in compliance with regulatory standards to ensure the safety and consistency of products.

We have an extensive, ever-evolving global client base along with impressive technical capabilities within a state-of-the-art GMP facility. As needs for the organization continue to evolve, we are looking for driven candidates who can grow with the organization. The successful candidate will be detail-oriented, proficient in review of analytical data for quality control, educated in analytical chemistry techniques, and have (or gain) experience in oligonucleotide analysis. The Technical Reviewer will work under the supervision of the QC Manager and collaborate directly with QC scientists to achieve timely corrections and delivery of results to internal and external stakeholders.

Routine tasks include review of analytical data and laboratory notebooks for LC-MS, KF, GC, Endotoxin and other analytical methods. Review and creation of CoAs, reports, and deviation investigations for release and stability results. Individuals may also perform sample testing for in-process manufacturing support, release of raw materials and investigation as required to maintain project timelines.

Qualifications

• Bachelor’s degree in Chemistry or the Life Sciences, 5+ years of industry experience and/or demonstrates proficiency to meet the requirements of a Quality Control Reviewer.
• 3-year minimum working in a GMP laboratory setting including OOX investigation experience.

• Must have strong organic chemistry and/or analytical chemistry knowledge, and proficiency in associated analytical techniques; HPLC, LC-MSMS or GC-MS, KF, FT-IR.
• Must have solid teamwork skills to interface with engineers, chemists, technicians, and analysts to ensure smooth laboratory and plant operations.
• Proficient in cGMP.

• Working knowledge of chromatography software including Empower, MassLynx, Chromeleon, and/or Waters Connect.
• Prior experience working in a CMO/CDMO manufacturing environment and understanding of ICH guidelines, Data integrity requirements and other regulatory requirements a plus.
• Good written and oral communication skills.

Additional Information

What we offer (US based-employees):

• Competitive compensation with strong bonus program
• Comprehensive medical, dental, and vision benefits for employees and dependents
• FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
• Deductible Buffer Insurance and Critical Illness Insurance
• 401(k) retirement plan with matching employer contribution
• Company-paid short- and long- term disability, life insurance, and employee assistance program
• Flexible work options
• Pet Insurance for our furry friends
• Enhanced Parental leave of 8 additional weeks
• PTO that begins immediately
• Town Hall monthly meeting onsite/virtual, Cheer program wher