Lead Technician, Manufacturing

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.
 

SHIFT HOURS: Monday to Thursday, 4:00 pm to 2:00 AM PST. 

Job Description

Position Summary

The Lead Technician is responsible for executing production processes for therapeutic oligonucleotides in a cGMP-compliant facility. This role supports the manufacturing of high-quality nucleic acid-based therapeutics through hands-on operation of equipment, adherence to standard operating procedures (SOPs), and meticulous documentation practices. The lead technician works closely with cross-functional teams including Quality Assurance, Process Development, and Manufacturing Sciences and technology to ensure consistent, safe, and efficient production.

To perform this job successfully, an individual must be able to perform each of the following essential functions satisfactorily.

Roles and Responsibilities

• Oligonucleotide Production
• Lead routine and non-routine operations under cGMP conditions: synthesis, cleavage and deprotection, purification, ultrafiltration and diafiltration, lyophilization, and other required chemical reactions.
• Support activities related to production such as lab sanitization, material movement, and safety checks.
• Equipment Operation
• Operate and maintain small and large scale equipment including synthesizers, chromatography systems, and lyophilizes.
• Perform instrument calibrations, preventative maintenance, and validations.
• Oversee equipment readiness in alignment with scheduled production.
• cGMP Compliance
• Demonstrate GDP in production records, logbooks, and other required documents.
• Oversee team compliance with internal standard operating procedures to ensure regulatory adherence to cGMP requirements.
• Lead Quality investigations, CAPA implementations, and audit readiness.
• Continuous Improvement
• Lead in troubleshooting activities related to production.
• Identify and execute improvement initiatives.
• Provide feedback and review of systems related to operations.
• Train and mentor new team members.
• Cross-Functional Collaboration
• Represent manufacturing in large and complex multi-department projects.

Qualifications

Minimum Qualifications:

• Associate’s or Bachelor’s degree in Biotechnology, Chemistry, or related field – OR – 3 years of experience in a cGMP chemical manufacturing role preferably oligonucleotide related.

Preferred Qualifications:

• Experience with mid to large laboratory equipment and operations.
• Experience operating within cGMP quality systems

Competencies & Behaviours:

• Strong interpersonal and communication skills
• Able to work in a fast paced and dynamic environment
• Detail oriented
• Able to identify, assess, and address problems efficiently

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- 8, 10 and 12 hour shifts available with option of day, swing and night shifts.
• Pet Insurance for our furry friends
• Enhanced Parental leave of 8 additional weeks
• PTO that begins immediately
• Full week paid off during the holidays
• Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Companywide social events, frequent catered lunches and much more!

The typical pay range for this role is:

Minimum: $24.87
Maximum: $41.46

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.

ABOUT LGC: 

LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high-quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality, and range. 

OUR VALUES

• PASSION
• CURIOSITY 
• INTEGRITY
• BRILLIANCE
• RESPECT

EQUAL OPPORTUNITIES 

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.

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

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