Senior Director, Biologics Analytical Development and Quality Control

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.
• Maintains monitoring and tracking of 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.
• Ledges 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.

Requirements

• 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.
• Expert knowledge of global CMC analytical and regulatory requirements, including establishment of product specifications, biophysical/biochemical characterization, and analytical comparability of products and intermediates.
• Hands-on working experience of global CMC regulatory submission and approval.
• 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.
• Strategic thinker with a hands-on approach; comfortable balancing long-term planning with day-to-day execution.
• Exceptional communication and relationship-building skills, with the ability to influence across levels and functions.
• Strong attention to detail and problem-solving skills.
• Ability to distinguish between critical and non-critical priorities.

Qualifications

• The anticipated base salary range for this position is $250,000 - $280,000.
• This role may also be eligible for a target annual bonus and equity-based compensation, as well as participation in the company’s benefit programs.
• Actual compensation will depend on several factors, which may include, but are not limited to relevant years of experience, educational background, and geography.

Benefits

• Korsana Biosciences is the sixth groundbreaking company launched by Paragon Therapeutics, a premier biotech incubator founded by Fairmount Funds in 2021, known for its expertise in discovering and developing cutting-edge therapeutic assets in-house.

Pay

The anticipated base salary range for this position is $250,000 - $280,000. This role may also be eligible for a target annual bonus and equity-based compensation, as well as participation in the company’s benefit programs. Actual compensation will depend on several factors, which may include, but are not limited to relevant years of experience, educational background, and geography.

Schedule

Not specified.