VP, CMC

Korsana Biosciences•Waltham, MA

16h•$300,000 - $340,000

About The Position

The Vice President of CMC (Chemistry, Manufacturing, and Control) at Korsana Biosciences will develop, implement, and execute CMC strategy in support of a best-in-class portfolio of preclinical and clinical programs. This leader will oversee the planning and execution of outsourced CMC activities including biologics technical development, cGMP manufacturing, release and stability testing, and will work proactively with external suppliers including CDMOs and contract labs to define project scope, mitigate risks, and ensure successful delivery with regard to technical quality, timelines and budget. The VP will partner closely with Research, Supply Chain, Clinical, Quality, Regulatory, and Program Management 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.

Requirements

Ph.D. in (bio)chemistry, (bio)chemical engineering (or other relevant physical or life sciences disciplines) or MS/BS with equivalent education or experience is required.
A minimum of 15+ years of experience in biologics development and manufacturing in biotech or biopharma industry with at least 5 years as CMC head.
Hands-on working experience in successful IND/IMPD/BLA/MAA submissions and approval
Demonstrated ability to develop, implement, and execute CMC strategy for biologics
Proven track record of CDMOs management in supporting biologics technical development and cGMP manufacturing.
Proven leadership capability in developing, coaching, leading and inspiring team members within CMC function
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

Nice To Haves

Experience in a fast paced, high-growth startup environment is preferred

Responsibilities

Develop, implement, and execute CMC strategy for biologics technical development including drug substance, drug product, combination product, analytical methods, cGMP manufacturing, and product release and stability testing
Provide technical leadership and oversee biologics product development, scale-up and tech transfer and analytical method development, qualification and validation with CDMOs and contract labs.
Build, maintain and evolve the CMC function to align with the growth of company’s pipeline
Lead the selection of CDMOs and contract labs, contract negotiation, and budget/scope management.
In partnership with QA, support deviation investigations and associated CAPAs implementation.
Author and review CMC sections, Module 3 Quality, of global regulatory submissions (IND/IMPD/BLA/MAA).
Ensure product supply for clinical and preclinical studies
Establish and maintain an understanding of current trends and emerging biologics development and manufacturing technologies to ensure that the team is at the forefront of biologics CMC.
Responsible for establishing and managing objectives/priorities and budgets for the CMC function
Develop and maintain SOPs, policies, and guidance documents relevant to areas of responsibility.
Regularly update executive management with respect to CMC deliverables and timelines