QC Scientist

Position Summary:

LGC's CMC Analytical Services Department provides characterization and analytical services to the NAT GMP group, an oligonucleotide therapeutic lab. We are looking for an enthusiastic and hard-working candidate to join our team of scientists to support the intake and release of raw materials used in manufacture, API release testing according to ICH Q3C and testing in accordance with defined stability protocols. We have an extensive, ever-evolving client base and impressive technical capabilities with state-of-the-art equipment in a GMP facility. As our inventory expands our need for organization increases, leading to establishing a permanent position focused on sample preparation and chromatographic analysis for Raw Materials, API and Drug Product samples.

The QC Scientist brings scientific experience to LGC and is open to both learning more and sharing knowledge with others. 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. Oversees routine analysis and method validation while driving continuous improvement via analytical metholdogies. 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.

Areas of Responsibility:

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

Essential Functions:

• Provide technical and early stage analytical support in the development of therapeutic GMP manufacturing capability, including developing and drafting 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 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.

Skills/Capabilities:

• 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.
• Experience in size exclusion, ion exchange, and reverse phase chromatography, and HRAMS techniques preferred.
• Proficient in organic and nucleic acid chemistry is preferred.
• Proficient in cGMP.
• Proven ability to execute multiple analytical methods at any given time.
• Good written, computer and oral communication skills.
• Solid understanding of analytical manufacturing support.
• Self-motivated individual who can work in a multi-disciplinary team.
• Good troubleshooting, communications, teamwork and team leading skills.

Education/Experience:

• Bachelor of Science degree in Chemistry, Biology or a scientific background with a minimum of 3 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.
• Proficient in organic and nucleic acid chemistry.
• Proficient in HPLC, MS and GMP.
• Proven ability to execute multiple analytical methods at any given time.
• Good written and oral communication skills.
• Solid understanding of analytical manufacturing support.