Scientist I, Process Development

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.

Position Summary:

The Scientist in LGC Axolabs Process Development will be responsible for independent optimization of scale up/down solid-phase oligonucleotide synthesis, purification, concentration, conjugation, and downstream processing steps in preparation for handover to routine manufacturing. This role involves working with cross-functional teams to ensure successful execution of each campaign including troubleshooting technical issues.

LGC Axolabs has an extensive, ever-evolving global client base along with impressive technical capabilities within a state-of-the-art GMP facility. As the needs for the organization continue to grow, we are seeking technically skilled and motivated candidates who can contribute to innovative solutions in oligonucleotide process development. The successful candidate will be detail-oriented, proficient in chemistry techniques, and capable of working independently while collaborating across teams to meet project goals. The Scientist will work under the guidance of a Lead Senior Scientist and/or the Process Development Manager and will interface with internal and external stakeholders.

Areas of Responsibility:

The Scientist is responsible for independent optimization and execution of all unit operations of custom oligonucleotide manufacturing including but not limited to: solid phase synthesis, cleavage and deprotection, preparative HPLC purification, conjugation chemistry, ultrafiltration/diafiltration, and lyophilization. Also included will be sample preparation of samples to the Analytical Development Team.

To perform this job successfully, an individual must be able to perform each essential function satisfactorily.

Essential Functions:

• Independently prepare solutions, samples, and instrumentation to support development procedures
• Advanced data interpretation and troubleshooting of process or instrumentation issues
• Collaborate with Senior Scientists in developing experimental designs and technical strategies
• Author SOPs and other analytical documents (e.g. Project Plan, QPP, TDR) with minimal oversight
• Basic understanding of relevant regulatory and pharmacopeia guidelines (FDA/ICH/USP) to ensure compliance in tech transfer activities.
• Actively participates in internal & client-facing technical discussions
  
  

Minimum Qualifications:

• Bachelor’s degree or equivalent experience in Chemistry, Biology, or a related subject area with 4 years of applicable experience, or Master’s degree or equivalent experience with 2 years in a related field
• Strong communication skills, both written and verbal, to effectively collaborate with internal cross-functional teams and external partners
• Demonstrated dedication to scientific excellence and alignment with LGC’s core values and quality standards
• Proficiency in Microsoft Office, Outlook, Word, Filemaker Pro, IFS, and Excel
• Self-starter with strong problem-solving skills and the ability to work independently and with the broader team

Preferred Qualifications:

• Technical understanding of oligonucleotide manufacturing processes and hands-on experience with relevant chemistry techniques, equipment, and methods
• Working knowledge of ChemDraw and Unicorn software (Synthesis and Purification)
• Prior experience in a GMP-regulated environment within a CMO/CDMO or pharmaceutical manufacturing setting

Physical Requirements:

The physical requirements outlined here reflect those that an employee must satisfy to effectively carry out the essential duties of this position. Reasonable accommodations can be provided to assist individuals with disabilities in performing these essential duties.

The typical pay range for this role is:

Minimum: $72,666 USD per year

Maximum: $121,109 USD per year

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 major international life sciences tools company, delivering key components and solutions to fast-growing application areas in human healthcare and applied market segments. Our high-quality product portfolio features important tools for genomic analysis and quality assurance applications, appreciated for their performance, quality, and scope.

Our values

• PASSION
• CURIOSITY
• INTEGRITY
• BRILLIANCE
• RESPECT

Equal opportunities

At LGC, we hold the conviction that every applicant and employee should be appreciated for their distinct skills, regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or parental leave, religion, or belief. Shortlisting, interviewing, and selection procedures are consistently performed without bias toward 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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