Senior Scientist, Analytical Development & QC-CMC Strategy

Proclinical Group; Town of Newark (WI); On-site; USD 150,000 - 160,000; Full time

Benefits offered by this job

Bonus potential

Equity potential

Job summary

Proclinical Group is partnering with a clinical-stage biotechnology company in the East Bay Area to recruit a Sr. Scientist, Analytical Development & Quality Control.

The role centers on leading analytical strategies for drug substance and product across development stages. The ideal candidate will have a PhD or MSc in Analytical Chemistry with deep experience in UHPLC/HPLC, LC-MS and characterisation of peptides, complex biologics or ADCs.

Qualifications

• PhD or MSc in Analytical Chemistry or related field.
• Experience in Analytical Development within pharma/biotech.
• Expertise in UHPLC/HPLC method development and validation.
• Experience with LC-MS and advanced analytical characterization techniques.
• Background supporting peptides, complex biologics, ADCs, proteins or related modalities.
• Experience managing external CDMOs or analytical service providers.
• Experience supporting CMC development through multiple clinical stages.
• Understanding of GMP, quality systems and regulatory expectations.
• Regulatory submission experience is advantageous.

Responsibilities

• Lead analytical development activities for drug substance and drug product programmes.
• Develop, optimise and validate analytical methods using modern chromatographic and spectroscopic techniques.
• Design analytical control strategies, specifications and characterisation plans.
• Support stability studies, comparability assessments and impurity characterisation activities.
• Manage analytical testing and development activities at external CDMOs and CROs.
• Review analytical data and provide scientific guidance on investigations, deviations and troubleshooting.
• Support regulatory submissions including INDs, IMPDs and marketing applications.
• Collaborate with cross-functional teams across CMC, Quality and Regulatory functions.
• Contribute to continuous improvement and scientific best practice across the organisation.

Skills

Analytical Development

UHPLC/HPLC method development

LC-MS & advanced characterization

Biologics/peptides/ADC experience

External CDMOs management

CMC development support

GMP & regulatory knowledge

Regulatory submission experience

Education

PhD or MSc in Analytical Chemistry or related

Job description

Proclinical Group is partnering with a clinical-stage biotechnology company in the East Bay Area to recruit a Sr. Scientist, Analytical Development & Quality Control.

The role centers on leading analytical strategies for drug substance and product across development stages. The ideal candidate will have a PhD or MSc in Analytical Chemistry with deep experience in UHPLC/HPLC, LC-MS and characterisation of peptides, complex biologics or ADCs.