Senior Director, Biologics Analytical Development and Quality Control

Korsana Biosciences, Inc.; Boston (MA); On-site; USD 250,000 - 280,000; Full time

Job summary

Korsana Biosciences, Inc. is seeking a Senior Director of Biologics Analytical Development and Quality Control to lead analytical development, QC activities, and external collaboration with CDMOs.

The role requires strategic leadership and hands-on management of early-stage programs in a dynamic biotech environment. The position emphasizes CMC strategy, regulatory submissions (IND/IMPD/CTA), and ensuring data quality for preclinical and clinical programs, with a base salary in the range of

Qualifications

• Ph.D. in chemistry/biochemistry or related field or MS/BS with equivalent experience.
• ≥12 years' hands-on biologics analytical development experience.
• Experience in fast-paced startup environments preferred.
• Experience with IND/IMPD/CTA submissions and approvals.

Responsibilities

• Establish CMC strategies for analytical development and testing.
• Collaborate with internal and external partners to push projects forward.
• Recommend specifications and document rationale.
• Monitor in-process, release, stability, OOT/OOS results.
• Support deviation and OOS investigations and CAPAs.
• Prepare CMC documentation for regulatory filings.
• Lead CDMO/CRO selection, negotiations, budget/scope.
• Stay current with biologics analytical technologies.
• Set goals to ensure timely, high-quality results.
• Provide progress updates to management.
• Ensure organized records.

Skills

Biologics analytics leadership

CMC regulatory knowledge

Analytical method development

Quality control

Outsourced/CDMO management

Regulatory submissions

Education

PhD in chemistry/biochemistry/biochemical engineering

Job description

Senior Director, Biologics Analytical Development and Quality Control

About this position

About Us

Korsana Biosciences is a private biopharmaceutical company advancing a pipeline of potential best-in‑class therapies for neurodegenerative diseases. In partnership with Paragon Therapeutics, we have developed Therapeutic Targeting (THETA™), a novel blood‑brain barrier‑penetrant shuttle platform designed to enable dramatically higher drug concentration inside the brain and overcome the limitations of earlier shuttle technologies. Our lead program is KRSA‑028, an investigational, shuttled antibody targeting amyloid beta designed to be a best‑in‑class treatment for Alzheimer’s disease. Our mission is to advance precision‑engineered therapies, designed to address some of the biggest unmet needs in medicine. For more information, please visit www.korsana.com

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 externalsuppliers 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 intermediates.
• Hands‑on working experience of global CMC regulatory submission and approval.
• 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

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 is not limited to relevant years of experience, educational background, and geography.

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.

Korsana Biosciences is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.