Senior Scientist II

About the role

Lead analytical development operations including status of client work, FTE, Cost model, material inventory and ensure Analytical team members write protocols and generate reports related to QC Method transfer, validation, and verification activities
Lead and support method development, qualification, transfer, validation, and verification of GMP analytical methods including but not limited to ddPCR, qPCR, ELISA, HPLC, Capillary electrophoresis, (CE-SDS), LCMS, Cell-based Assays (e.g. TCID50, Gene expression, flow cytometry, and Potency).

Responsibilities

• Support monitoring of on-going analytical method performance (e.g. system suitability trending) to drive continued improvement and optimization of OXB’s analytical methods.
• Assist with data trending of assay controls and reference standards, as needed.
• Lead and support analytical troubleshooting, as needed.
• Partners with internal and cross-functional departments (e.g. QC, Internal QA, External QA) to ensure success of analytical services program.
• Presentation to cross-functional teams and effectively communicate critical analytical issues and solutions.
• Mentor and develop associates and scientists in analytical development.

Requirements

• Bachelor’s degree in biology, Chemistry or equivalent; advanced degree preferred
• 10+ years of related experience post-degree
• Proven ability to lead cross-functional teams and client-facing technical discussions
• Extensive experience in analytical method development, qualification and tech transfers
• QC experience is a plus
• Demonstrated expertise in analytical method development supporting viral vectors for gene therapy
• Knowledge of quality principles and GMP, ICH and GLP regulations
• Familiarity with HPLC, AUC, CE-SDS, ELISA, ddPCR, qPCR and Cell based assays
• Experience creating/revising/reviewing operational SOPs, technical documents, protocols, and reports
• Strong written and verbal communication skills
• Experience with CDMO environment is highly desirable

Qualifications

• BS/BA in Biology, Chemistry or related field
• Advanced degree preferred
• 10+ years of related experience post-degree
• Proven ability to lead cross-functional teams and client-facing technical discussions
• Extensive experience in analytical method development, qualification and tech transfers
• QC experience is a plus
• Demonstrated expertise in analytical method development supporting viral vectors for gene therapy
• Knowledge of quality principles and GMP, ICH and GLP regulations
• Familiarity with HPLC, AUC, CE-SDS, ELISA, ddPCR, qPCR and Cell based assays
• Experience creating/revising/reviewing operational SOPs, technical documents, protocols, and reports
• Strong written and verbal communication skills
• Experience with CDMO environment is highly desirable

Skills

• Leadership and Team Management
• Technical Expertise
• Client Relationship Management
• Quality Assurance
• Communication and Presentation Skills

Benefits

• Competitive total reward packages
• Wellbeing programs that support your mental and physical health
• Career development opportunities to help you grow and thrive
• Sustainable, inclusive, and collaborative culture
• State-of-the-art labs and manufacturing facilities
• A company that lives its values: Responsible, Responsive, Resilient, Respect

Pay

$145,000 - $170,000 per year

Schedule

Full-time