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Head of Drug Substance 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 CMC Drug Substance Development

Department: Technical Operations

Reports To:  Chief Technical Operations Officer

 

Job Overview

Kardigan is seeking a Head of CMC Drug Substance Development, to support development of a large late phase portfolio. This role will report directly to the Chief Technical Operations Officer.                                             In this role, you will be responsible for the API development of Kardigan’s portfolio of medicines. Responsibilities include chemical route optimization, process development, manufacture and supply of drug substance; including the leadership, management and oversight of all outsourced chemical development, process development, scale-up, validation, technology transfer, and file launch activities required to support Kardigan’s portfolio of small molecules and oligonucleotides.  This role will include oversight and management of 3rd party CDMOs and CMOs. The role is accountable for leading the drug substance development team accountable for the successful drug substance process development and scale-up, technology transfer, 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 Chemical Development group that can successfully support a growing portfolio of both early phase, and also multiple complex late phase assets.
  • Manage and oversee final synthetic route development and optimization, process development, scale-up, validation, technology transfer, and clinical/commercial drug substance manufacturing to support multiple early and late Phase clinical development programs and future commercial supply.
  • Ensure the development of each asset meets the requirements for route, process, yield, COG and quality 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 batch records, manage internal batch release activities.
  • Establish appropriate drug substance specifications and stability studies in partnership with Anlaytical, Quality, CDMOs, Regulatory, and other subject matter experts to support intended use.
  • Write and review protocols, reports, and drug substance t sections for regulatory documents.
  • Contribute to product investigations and conduct root cause analysis.
  • Interface and coordinate activities with drug product, analytical development, regulatory affairs, quality assurance, and product supply to ensure on time release and uninterrupted supply of drug substance.
  • 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 manufacturing practices.
  • Monitor status of CDMO capacity, manage inventory risks and make recommendations to Kardigan’s executive leadership.
  • Manage the negotiation of contracts broadly applicable to drug substance manufacturing including ownership of the contract deliverables and obligations.
  • Leads the development of Kardigan’s drug substance development and manufacturing team, including overseeing new employees onboarding and providing career development planning and learning opportunities.
  • Attract, develop and grow key talent

 

Qualifications and Preferred Skills

  • BS. or PhD in pharmaceutical sciences, engineering, or related discipline. Advanced degree preferred.
  • Minimum 15 years' experience within pharmaceutical CMC development and Technical Operations. Experience with both small molecule and oligonucleotide products is preferred.
  • Sound knowledge of chemical development, process engineering and plant operations
  • Demonstrated experience with drug substance process development, scale-up, and optimization 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
  • Experience with process validation and continuous process improvement.
  • Ideally experience with commercializing small molecule and oligonucleotide drug products
  • Extensive knowledge of regulated manufacturing, 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

$270,000 - $372,000 USD

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