Senior Scientist , Quality Control

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

This is an Swing Shift: Monday-Thursday (4 x 10 hours, 1pm - 11:30pm).

The QC Senior Scientist role brings scientific experience while driving continuous improvement. Responsible for setting up instrument sequences, monitoring analysis and data and performing instrument troubleshooting, maintenance and reporting of results for on-time delivery to internal and external stakeholders. Maintains appropriate quality control processes and procedures to determine accuracy and precision of analysis. Familiar with GMP guidelines 21 CFR Part 210/211 and ICHQ7. Performs work under the supervision of the CMC Management but relies on experience to organize day-day work, priorities while supporting fast-turnaround investigations.

• Provide technical and early-stage analytical support in the development of therapeutic GMP manufacturing capability, including qualification and reporting of analytical procedures.
• Collaborate with the LGC staff in the transfer of analytical methods from our European sites to our GMP lab in Petaluma, CA.
• Develop and validate analytical methods to support process development and scale up synthesis, purification and downstream processing methods in preparation for handover to commercial manufacturing sites.
• Characterize oligonucleotides intended for therapeutic use.
• Keep good documentation records of analytical activities, experimental procedures and analytical data.
• Thoroughly follow written procedures, accurately and completely documenting work as executed according to cGMP and LGC procedures.
• Maintain the analytical chemistry laboratory space in compliance with safety regulations. 
• Provide technical support in root cause failure analysis for production and quality incidents.
• Provide technical customer support and routine progress updates to clients in conjunction with the project manager assigned to each specific project.
• Assist with plant scale-up trials and interface with daily production execution and technology teams.
• Be a technical resource for coaching and developing of laboratory personnel into a high-performance team through the development and improvement of new and existing analytical methods and training the rest of the team.
• Author SOPs and other various documents.

Qualifications

Minimum Qualifications:

• Bachelor of Science degree in Chemistry, Biology or a scientific background with a minimum of 5 years of practical analytical laboratory experience in support of process / product development in a  manufacturing environment or Masters of Science degree with >2 years of direct experience or a PhD with < 2 years of direct 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. 
• Proven ability to execute multiple analytical methods at any given time.
• Solid understanding of analytical manufacturing support.

Preferred Qualifications:

• Experience in size exclusion, ion exchange, and reverse phase chromatography, KF, FT-IR and NMR techniques preferred

Additional Information

What we offer (US based-employees):

• Competitive compensation with strong bonus program
• Comprehensive medical, dental, and