Senior Manager, CMC Analytical Sciences

This is a fully remote position, open to applicants in United States.

📋 Description

• Direct and oversee analytical operations performed by external laboratories and contract development and manufacturing organizations (CDMOs).

• Offer expert technical guidance in CMC analytical sciences, including the development, qualification, validation, and transfer of analytical methodologies.

• Collaborate across various functions to ensure that analytical strategies align with regulatory standards.

• Lead and manage ICH-compliant stability programs, including forced degradation studies.

• Gather, review, and analyze analytical data to support development programs.

⛳️ Requirements

• A Bachelor’s degree in biochemistry, chemistry, biology, chemical engineering, or a related pharmaceutical science is required; an advanced degree is preferred.

• Over 9 years of experience in biopharmaceutical product development, specifically in managing CMC analytical activities.

• Strong preference for experience in vaccines, cell therapy, or gene therapy.

• Proven experience supervising CDMOs and/or managing remote external analytical operations.

• Robust technical knowledge in biologics and/or vaccine development.

• Practical experience with analytical techniques such as qPCR/RT-PCR, HPLC, ELISA, mass spectrometry, light scattering, and cell-based potency assays.

• Demonstrated ability to define and justify Critical Quality Attributes (CQAs).

• Strong preference for experience supporting GMP manufacturing process characterization.

• In-depth knowledge of US and EU CMC regulatory requirements.

• Comprehensive understanding of current Good Manufacturing Practices (cGMPs).

• Experience in authoring CMC sections for INDs, NDAs, BLAs, and submissions to regulatory bodies outside the US.

• Exceptional attention to detail, along with excellent organizational and problem-solving abilities.

• Willingness to travel both domestically and internationally as necessary.

🏝️ Benefits

• A comprehensive benefits package that includes medical, dental, and vision coverage.

• Flexible spending accounts.

• Flexible vacation and sick leave policies.

• Employer-paid life and disability insurance.

• Recognition of 11 federal holidays.

• An end-of-year winter break.

• An employer-matching 401(k) plan.