Manager, Analytical Development

Role Summary

We’re looking for a Manager on the Analytical Development team to help us expand what’s possible for patients with serious diseases. The role involves managing testing support for product characterization, collaborating with internal groups, and overseeing testing performed by external CDMOs/CTLs. The position includes supervising direct reports, sample management, forecasting, and method transfer activities to QC.

Responsibilities

• Collaborate with research process development, and QC teams to develop, qualify/validate/transfer analytical methods for process monitoring and drug product release
• Collaborate with research and process development teams to determine critical quality attributes (CQAs), monitor process and method performance, and troubleshoot as needed
• Establish control limits for in-process samples and specifications for drug substance and drug products
• Perform laboratory testing to support various non-GMP activities
• Develop and own timelines and protocols for assay qualifications and transfers
• Author, review, and approve analytical development protocols and reports
• Ensure the timely execution of requested development sample testing and preparation of reports as needed
• Manage sample forecasting and delivery to internal and external partners
• Establish stability plans, manage stability tests and reference standards
• Establish and manage AD operations function in AD laboratory, ensuring continued supply of materials, equipment, and reagents and maintaining equipment calibration status

Qualifications

• PhD in a relevant discipline with 4+ years of relevant industry experience, or Master’s degree with 7+ years of relevant industry experience, or Bachelor’s degree with 12+ years of relevant industry experience
• Experience in the pharmaceutical industry within the analytical development functional group, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing
• Experience in transferring methods to a GMP environment
• Experience with laboratory and project management software (ELN, Smartsheet, LIMS, etc.)
• Entrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinic
• Excellent organizational and communication skills
• Experience with direct reports or managing people

Education

• PhD in a relevant discipline with 4+ years of industry experience, or Master’s degree with 7+ years, or Bachelor’s degree with 12+ years

Skills

• Analytical method development and transfer
• Laboratory and QA/QC collaboration
• Program and project management
• Strong communication and leadership capabilities

Additional Requirements

• Travel: Minimal travel expected