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Head of Analytical Development

South San Francisco, California, United States, Princeton, New Jersey, United States

About Us 

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is our mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. 

At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.   

These values are the foundation of our work, empowering us to make a real difference, every day.  

 

Position Title: Head of Analytical Development

Department: Technical Operations

Reports To: Chief Technical Operations Officer

 

Job Overview

Kardigan is seeking a VP Head, Analytical Development, Technical Operations, to support development of a large late phase portfolio. This role will report directly into the Chief Technical Operations Officer.                        In this role, you will be responsible for the leadership, management and oversight of all outsourced analytical development, activities required to support Kardigan’s portfolio of small molecules and oligonucleotides. The scope of the role will cover drug product, drug substance, development clinical and commercial supply. This hands-on role will develop and lead the analytical development team accountable for development, scale-up, technology transfer, clinical supply, registration and validation lots, authoring of Module 3 documents and working closely with CDMOs to support inspection readiness. This is a 4-day, onsite position, based in South San Francisco or Princeton NJ.

 

Essential Duties and Responsibilities

Build and lead a high performing, experienced analytical development group that can successfully support a growing portfolio of both early phase, and also multiple complex late phase assets.

  • Manage and oversee outsourced analytical method development, method transfer, and clinical/commercial batch release testing, stability testing to support multiple early and late Phase clinical development programs and future commercial supply.
  • Ensure the development of each asset meets all quality and regulatory requirements to enable the successful commercialization of the products under development
  • Develop phase-appropriate pharmaceutical project plans, participate in CDMO selection, and manage successful execution of these plans consistent with corporate timelines and compliant with cGMP/regulatory requirements and expectations.
  • Develop, review, and approve analytical methods and batch release documents as required
  • Establish appropriate drug substances and drug product, methods, specifications and stability studies in partnership with drug substance and drug product development, clinical supply, Quality, CDMOs, Regulatory, and other subject matter experts to support intended use.
  • Write and review protocols, reports, required sections for regulatory documents.
  • Contribute to product investigations and conduct root cause analysis.
  • Interface and coordinate activities with drug product, drug substance development, regulatory affairs, quality assurance, and product supply to ensure on time release and uninterrupted supply of API and clinical supplies.
  • Collaborate with legal and procurement to review contract terms and execution of agreements.
  • Keep up with the latest regulatory and cGMP guidance and awareness of state-of-the-art analytical practices.
  • Monitor status of CDMO capacity, timelines risks and make recommendations to Kardigan’s executive leadership.
  • Manage the negotiation of contracts broadly applicable to analytical development and testing and ownership of the contract deliverables and obligations.
  • Leads the development of Kardigan’s analytical development and testing team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
  • Attract, develop and grow key talent

 

Qualifications and Preferred Skills

B.S. or PhD in pharmaceutical sciences, engineering, or related discipline. Advanced degree preferred.

  • Minimum 15 years' experience within analytical CMC development and Technical Operations. Experience with both small molecule and oligonucleotide products is preferred.
  • Sound knowledge of analytical development, testing and batch release
  • Demonstrated experience with analytical development, method transfer and , from R&D through commercialization, including an understanding of the interdependencies of functional groups and working closely with external CDMOs.
  • Significant experience in working with global health authorities, IND, IMPD, NDA, MAA etc
  • Ideally experience with commercializing small molecules and oligonucleotide drug products
  • Extensive knowledge of regulated, GMP, GCP and quality systems.
  • Creative/innovative/problem solver that actively drives progress.
  • Ability to manage multiple projects in a fast-paced environment.
  • Strong interpersonal communication skills, proven ability to build and maintain collaborative, effective internal and external relationships.
  • Excellent written, oral communication, and presentation skills along with the ability to communicate effectively with executive-level management.
  • Ability to effectively collaborate in a dynamic, cross-functional matrix environment.

 

Exact Compensation may vary based on skills, experience and location.

Pay range

$272,000 - $374,000 USD

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