PURPOSE OF JOB

The Senior Director of Biologics Analytical Development is responsible for leading analytical activities supporting the development and commercialization of innovative biologics, including monoclonal antibodies. This highly visible leadership role will oversee method development, characterization, analytical control strategies, and regulatory submissions spanning early-stage development through commercial lifecycle management..

MAJOR DUTIES AND RESPONSIBILITIES

• Lead all aspects of analytical development from early development through commercialization.
• End-to-end analytical ownership from preclinical through commercial, including lifecycle management of analytical methods.
• Accountable for both internal lab execution and external partnerships (CDMOs, CROs) on analytical development, batch release, and method validation activities.
• Responsible for the design, development, qualification, and lifecycle management of analytical methods to support release, stability, comparability, and characterization testing.
• Define and implement phase-appropriate analytical control strategies integrated with QbD principles to support regulatory filings and commercial readiness.
• Establish and maintain product specifications in alignment with critical quality attributes (CQAs), clinical phase, manufacturing process understanding, and statistical justification.
• Collaborate with Process Development to ensure linkage between CQAs and process parameters.
• Develop and validate methods to evaluate protein stability, aggregation, degradation, solubility, charge variants, PTMs, and compatibility with formulation and drug delivery devices.
• Integrate analytical data into formulation selection and device interface development
• Collaborate cross-functionally with Process Development, Formulation, Quality, Regulatory, and external CDMOs to ensure analytical alignment and technical robustness across all stages.
• Drive analytical comparability strategies to support process changes, site transfers, or lifecycle management.
• Define and execute regulatory strategies and author analytical sections of CMC submissions (e.g., Module 3), support inspection readiness.
• Leverage data analytics platforms and advanced informatics tools to support method trending, OOS/OOT investigation, real-time release testing, and continued process verification.
• Serve as the analytical lead for regulatory submissions (IND, IMPD, BLA/MAA).
• Provide strategic leadership in CMC Teams, Analytical Sciences governance, and internal Scientific Review Boards.
• Mentor and grow a team of analytical scientists; foster a culture of scientific excellence, compliance, and technical leadership.

EDUCATION REQUIREMENTS

• PhD in Analytical Chemistry, Biochemistry, or related discipline with 12+ years (or MS with 15+ years) of industry experience in analytical development for biologics.

EXPERIENCE REQUIREMENTS

• At least 10 years managerial experience.
• Proven experience leading analytical development for monoclonal antibodies or complex biologics through all stages of development, including BLA/MAA submission and commercial launch.
• Late-stage development (validation) experience of biologics drug substance is required.
• Deep understanding of analytical methods (e.g., cIEF, SEC, CE-SDS, icIEF, LC-MS, peptide mapping, binding assays) and their application in CMC development and regulatory strategy.
• Demonstrated expertise in setting, justifying, and maintaining product specifications across the development lifecycle.
• Experience with developability profiling and integration of analytics into manufacturability risk assessment.
• Strong knowledge of ICH, USP, and regulatory expectations for biologics.
• Excellent leadership, strategic thinking, and communication skills.
• Experience handling technology transfer and technical support including OOS, deviations, and troubleshooting of drug substance manufacturing processes.
• Extensive experience collaborating with and overseeing CMOs and third-party manufacturers.
• Demonstrated experience with track record of success leading technical teams, experience in process scale-up and development of scale-down models.
• Must-have advanced knowledge of DOE principles, process characterization, and BLA submission.
• Proven leadership experience and strong people management skills with the desire and ability to deliver on objectives while developing people in a dynamic and fast-paced environment.
• Broad experience in cGMP biologics manufacturing and understanding of ICH regulatory guidelines.

OTHER QUALIFICATIONS

• Possess advanced biologics process development skills combined with exceptional project leadership, organization, and communication skills.
• Ability to communicate effectively and connect with all levels of the organization.
• Strong project leadership and resource management skills.
• Require excellent written/oral communication.
• Travel up to 25%

California law requires pay information in job postings. The specific rate will depend on the successful candidate’s qualifications, prior experience, and other relevant factors. The estimated annual pay range for this position is $263,400 (entry-level qualifications) to $286,900 (highly experienced).