Senior Manager Analytical Operations

About the role

For our client, we are seeking a Senior Manager Analytical Operations to join the team of a leader in the Pharmaceuticals & Biotech space. This role will oversee analytical development and quality control activities across contract manufacturing sites, ensuring methods, documentation, and programs support compliant product development and release. The position partners closely with Quality Assurance and cross-functional technical teams to strengthen stability oversight, manage critical materials, and advance regulatory readiness. The ideal candidate will bring deep experience in analytical science, CMC requirements, and global filing support for biologics and small molecules. The work will have a direct impact on data quality, technical reporting, and successful regulatory submissions in a highly regulated biotech environment. Location: Remote - US based candidates only, no visa sponsorship available.

Responsibilities

• Manage analytical development and quality control activities at contract manufacturing sites
• Review documentation related to analytical method transfer and validation
• Monitor and review stability protocols and programs
• Author and approve analytical technical reports and regulatory filing sections
• Collaborate with Quality Assurance to address investigations and deviations
• Manage reference standards and critical reagents programs
• Support batch release through analytical data review and approval

Qualifications

• At least 10 years of experience in Analytical Development and/or Quality Control within the pharmaceutical sector
• Strong understanding of CMC analytical regulatory requirements and experience with IND/IMPD/BLA/NDA/MAA filings
• Proficiency in a variety of analytical techniques for biologics and small molecules
• In-depth knowledge of cGMPs, USP, ICH guidelines, and industry best practices
• Expertise in stability program management, including protocol design and data analysis

Benefits

• 401(k) with employer match
• Employee Stock Purchase Program (ESPP)
• 100% employer-paid medical, dental, and vision premiums for employees and their dependents
• Flexible spending accounts (FSA) and Health Savings Account (HSA) with employer contributions
• Hybrid work model that offers flexibility

Pay

$130,000 – $159,700 annually