Scientist I, Manufacturing

Job Description

Job Description

Company Description

LGC 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.

LGC 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

Explore an outstanding opportunity to join a world-class team at LGC as a Scientist I, Manufacturing. In this role, you will play a crucial part in supporting therapeutic oligonucleotide manufacturing by flawlessly transferring processes from development stages to GMP manufacturing. You will author essential documentation, drive process improvements, and collaborate closely with both internal teams and clients to ensure our manufacturing processes are exceptionally efficient and compliant.

Roles and Responsibilities :

• Move protocols from development labs to GMP manufacturing, ensuring seamless implementation and adherence to scale-up documentation.
• Author critical manufacturing documents, including manufacturing reports, batch records, and risk assessments.
• Implement innovative methods and tools to drive manufacturing growth and process improvements. This includes writing and implementing validation protocols, setting up small equipment, and developing new SOP / WI.
• Provide comprehensive process training to chemists regarding new processes being transferred to the manufacturing suite.
• Lead and support deviation investigations, offering technical support in root cause failure analysis for production and quality incidents.
• Actively participate in internal and client-facing technical discussions and audits to ensure transparency and collaborative problem-solving.
• Support the material supply chain for manufacturing projects to ensure timely execution of campaigns.
• Ensure strict compliance with cGMP, FDA, and other regulatory standards.
• Stay updated with relevant regulatory and pharmacopeia guidelines (FDA / ICH / USP) to ensure compliance in tech transfer activities.

Qualifications

Minimum Qualifications :

Preferred Qualifications :

Skills and Abilities :

Additional Information

What we offer (US based-employees) :

The typical pay range for this role is :

Minimum : $ 72,660 yearly

Maximum : $ 121,109 yearly

This 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.

All your information will be kept confidential according to EEO guidelines.

For more information about LGC, please visit our website www.lgcgroup.com

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