Senior QC Scientist: Lead Method Transfer & Validation (Onsite)

Abgenix; Redwood City (CA); On-site; USD 160,000 - 175,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

401k with Company Match up to 4%

Company Equity

Generous Paid Time Off incl. holidays

Job summary

Codexis Inc in Redwood City, CA seeks a Sr. Scientist to lead analytical method transfer and validation for oligonucleotide and enzyme products. This on-site role will help build the QC lab in a GMP facility, with future moves or hybrid work between Redwood City and Hayward.

The candidate will manage method lifecycle, method validation strategies, and oversee analytical instrumentation. Strong leadership and cross-functional collaboration are required.

Qualifications

• PhD or equivalent with 4+ years in a regulated environment.
• Working knowledge of cGMP and ICH guidelines.
• Proven experience in developing analytical method validation strategies and execution.
• Deep technical knowledge of LC-MS, IP-RP-HPLC and AEX chromatography for oligonucleotide analysis.
• Strong analytical techniques for biological products (ELISA, qPCR, UV-Vis, CE-SDS, HPLC, GC).

Responsibilities

• Lead analytical method transfers and validation activities with protocol design, execution and reporting.
• Author transfer/validation protocols, technical reports, SOPs and regulatory filing sections.
• Manage lifecycle of analytical methods and instruments, including qualification and change control.
• Perform advanced analytical testing for raw materials, in-process, and finished products.
• Provide technical oversight for QC analytical methods and instrumentation; troubleshoot deviations and investigations.
• Design, execute, and oversee stability programs with data review and reporting.
• Support QC systems and laboratory practices across ISO 9001 and GMP transition.

Skills

PhD life sciences

cGMP knowledge

Analytical method validation

LC-MS

IP-RP-HPLC

AEX chromatography

ELISA

qPCR

UV-Vis

CE-SDS

HPLC

GC

Education

PhD in life sciences/chemistry/biochemistry

MS/BS with 10+ years in regulated env

Tools

LC-MS

IP-RP-HPLC

AEX chromatography

Job description

Codexis Inc in Redwood City, CA seeks a Sr. Scientist to lead analytical method transfer and validation for oligonucleotide and enzyme products. This on-site role will help build the QC lab in a GMP facility, with future moves or hybrid work between Redwood City and Hayward.

The candidate will manage method lifecycle, method validation strategies, and oversee analytical instrumentation. Strong leadership and cross-functional collaboration are required.