Senior Director, Biologics Analytical Development and Quality Control

Senior Director, Biologics Analytical Development and Quality Control

Position Overview

The Senior Director, Biologics Analytical Development and Quality Control, will provide program-specific leadership and subject matter expertise for analytical development and quality control activities in support of a best-in-class portfolio of preclinical and clinical programs. This leader will oversee the planning and execution of outsourced analytical development and testing activities and will work proactively with external suppliers including CDMOs and contract labs to define project scope, mitigate risks, and ensure successful delivery in relation to technical quality, timelines and budget.

The incumbent will collaborate with other functions to deliver quality products for preclinical studies and clinical trials and Module 3 Quality for regulatory submission and approval. The position requires strategic vision and hands-on experience managing early-stage biotech programs in a dynamic, fast-paced environment.

Responsibilities

• Establishes effective CMC strategies for analytical method development/qualification/validation, product characterization and in-process and final product testing for a portfolio of biologics products in keeping with corporate and program objectives.
• Collaborates with internal stakeholders in the areas of Drug Substance Development, Drug Product Development, Combination Product Development, Clinical Supply Chain, Program Management, Preclinical Development, Clinical Development/Operations, Quality, Regulatory Affairs, and external business partners to push project forward.
• Recommends raw material, in-process and final product specifications. Generates and maintains appropriate documentation to support rationale for specifications.
• Monitors and tracks in-process, product release and stability testing results, as well as OOT and OOS results. Recommends and implements risk management strategies to address technical challenges and meet business goals.
• In partnership with QA, supports deviation and OOS investigations, and associated CAPAs for product release, stability testing, and temperature excursions.
• Prepares CMC documentation for regulatory and/or patent filings.
• Leads CDMO/CRO selection, contract negotiation, and budget/scope management related to analytical development and testing.
• Establishes and maintains an understanding of current trends and emerging biologics analytical technologies to ensure that the team is at the forefront of biologics analytical development.
• Sets clearly defined goals/objectives to ensure delivery of high-quality results in keeping with approved timelines and budgets.
• Provides clear communication to management regarding progress against technical objectives/milestones.
• Ensures well-organized, clear and complete records of all activities across areas of responsibility.

Education & Experience

• Ph.D. in (bio) chemistry, (bio) chemical engineering (or other relevant physical or life sciences discipline) or MS/BS with equivalent education or experience is required.
• A minimum of 12 years of hands-on working experience in biologics analytical development in biotech or biopharma industry.
• Experience in a fast paced, high-growth startup environment is preferred
• Experience in successful IND/IMPD/CTA submissions and approval

Skills & Attributes

• Demonstrated ability in the areas of leading and managing biologics analytical method development, qualification, validation, transfer, and product release and stability testing activities in an outsourced business model.
• Expert knowledge ofglobal CMC analytical and regulatory requirements, including establishment of product specifications, biophysical/biochemical characterization, and analytical comparability of products and…