Senior Manager, CMC Analytical Development

Who You Are

The Senior Manager of Analytical Development will join the Analytical Development Team within Chemistry and Manufacturing and Controls (CMC) and report to a Director of Analytical Development. This role will work closely with the entire CMC team to execute late-stage development activities in support of Phase III clinical trials through commercial activities. Candidates for this position will be required to work independently and have experience managing outsourced analytical activities at contract manufacturing sites and testing labs.

Where You'll Work

This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Responsibilities

_Oversee contract development and manufacturing organizations (CDMOs) to manage analytical development and quality control (QC) activities for drug substance (DS) and product (DP)

• Manage analytical documentation (i.e., CofAs, test methods, protocols, reports, specifications, stability, and raw data) within Quality Management System (QMS)

• Support and author analytical content for CMC Regulatory content for U.S. and Rest of World dossiers

• Manage GMP stability studies and provide trend analysis in support of retest and shelf-life extension

• Manage reference standard program (i.e., qualification, storage, inventory, distribution)

• Development and approval of specifications for raw materials, intermediates, and finished product and knowledge of regulatory requirements in the setting of specifications

• Development and validation of analytical methods and verification of compendial methods

• Able to communicate results both internally and externally through oral and written updates and formal reports as necessary

• Provide analytical support for API and Drug Product process development

• Authoring of development reports, protocols, and methods

• Support quality audits as a technical representative and contribute to authoring of audit reports

Education, Experience & Skills Requirements

• At least 7 years of experience in analytical development in a pharmaceutical setting

• Proven leadership experience in managing analytical chemists at various levels externally (CMO mgmt.)

• Independently proficient in a variety of analytical techniques and regulatory areas including, but not limited to HPLC, LC/MS, GC, GC/MS, USP dissolution testing apparatus, pH meters, UV/Vis spectroscopy, KF, and phase appropriate analytical method validation

• Knowledge and direct experience with CMC analytical regulatory requirements and authoring of IND/IMPD filings and response to regulatory inquiries; experience applying regulatory guidelines (ICH, FDA, EMA, etc.) to pharmaceutical development and CMC strategy

• Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates. Ability to understand project timelines and appropriately prioritize activities to achieve project goals

• The position will require an ability to adapt to changes in priorities on short notice and will also need an ability to make decisions, independently, under tight timelines

• Travel up to 20%