Senior Director, Drug Substance Development - Princeton - Kardigan

    Kardigan
    Kardigan Princeton

    1 week ago

    $229,000 - $298,000 (USD) per year
    Description

    Senior Director, Drug Substance Development


    Kardigan is a heart health company committed to making cardiovascular disease preventable and curable. The mission is to develop targeted treatments for cardiovascular diseases to bring patients the cures they deserve. Led by founders Tassos Giannakakos, Jay Edelberg, M.D., and Bob McDowell, Ph.D., Kardigan has a cutting‑edge discovery platform, a pipeline of late‑stage candidates, and an industry‑leading team.

    We value patients, authenticity, learning, teamwork, and innovation. These values guide how we work and enable us to make real differences.

    Department: Technical Operations
    Reports To: VP Head of DS Development

    Job Overview


    Senior Director to support development of a large late‑phase portfolio leading to an NDA. This role reports to the VP of DS Development and will oversee API development of Kardigan's portfolio of medicines. Responsibilities include chemical route optimization, process development, manufacturing, scale‑up, validation, technology transfer, and regulatory file launch. Leadership over outsourced chemical development and CDMOs/CMOs is required. The position is onsite 4 days a week in Princeton, NJ.

    Essential Duties and Responsibilities

    • Build and lead a high‑performing Chemical Development group supporting early and late‑phase assets.
    • Oversee final synthetic route development, process development, scale‑up, validation, technology transfer, and commercial drug substance manufacturing.
    • Ensure each asset meets synthetic route, process, yield, and quality requirements for successful validation and commercialization.
    • Develop phase‑appropriate project plans, manage CDMO selection, and execute plans in line with corporate timelines and cGMP/regulatory requirements.
    • Apply risk‑assessment tools to control impurities and comply with ICH guidelines.
    • Approve batch records, manage internal releases, and establish drug substance specifications and stability studies in partnership with Analytical, Quality, CDMOs, and Regulatory experts.
    • Write and review protocols, reports, and drug substance sections for regulatory documents.
    • Contribute to product investigations and root‑cause analysis.
    • Coordinate with drug products, analytical development, regulatory affairs, QA, and product supply for on‑time release and uninterrupted supply.
    • Stay current on regulatory and cGMP guidance and advanced manufacturing practices.
    • Monitor CDMO capacity, manage inventory risks, and advise executive leadership.

    Qualifications and Preferred Skills

    • Advanced degree (Bachelor, MS, or PhD) in organic chemistry or related discipline.
    • Minimum 15 years in pharmaceutical CMC development and Technical Operations, with experience in small‑molecule and oligonucleotide products.
    • Sound knowledge of chemical development, process engineering, and plant operations.
    • Experience in drug substance development, scale‑up, technology transfer, and optimization from R&D to commercialization.
    • Involvement in NDA submission for oligonucleotide or small‑molecule programs.
    • Experience working with global health authorities (IND, IMPD, NDA, MAA).
    • Experience in process validation and continuous improvement.
    • Experience commercializing small molecules and oligonucleotide drug substances.
    • Extensive knowledge of GMP, GCP, and quality systems.
    • Creative, innovative problem‑solver who drives progress.
    • Ability to manage multiple projects in a fast‑paced environment.
    • Strong interpersonal and written communication skills, including executive‑level presentation ability.
    • Collaborative in a cross‑functional matrix environment.

    Compensation


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

    Pay range: $229,000 – $298,000 USD

    Equal Employment Opportunity


    As set forth in Kardigan's Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

    Voluntary Self‑Identification


    For government reporting, we ask candidates to voluntarily complete a self‑identification survey. Completion is optional and will not be used in the hiring process.


    #J-18808-Ljbffr
  • Work in company

    Director, Drug Substance Development

    Only for registered members

    Kardigan is seeking an experienced Director of CMC Drug Substance Development to oversee the development of its pipeline and portfolio across small molecules and oligonucleotides. · Cross-functional collaboration with drug product development teams. · Maintain awareness of evolvi ...

    Princeton $202,000 - $263,000 (USD)

    1 month ago

  • Work in company

    Director, Drug Substance Development

    Only for registered members

    We are looking for a Director to join the Drug Substance team within the Technical Operations department at Kardigan Bio. · This role will support clinical and commercial product lifecycle management including authoring technical assessments monitoring process performance continu ...

    Princeton $202,000 - $263,000 (USD) Full time

    1 month ago

  • Work in company

    Associate Director, Drug Substance Development

    Only for registered members

    · 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 Kardigan's mission to develop multiple targeted treatments in parallel that bring people with cardiovascula ...

    Princeton, New Jersey, United States

    1 week ago

  • Work in company

    VP, Head of Drug Substance Development

    Only for registered members

    · 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 Kardigan's mission to develop multiple targeted treatments in parallel that bring people with cardiovascula ...

    Princeton, New Jersey, United States

    1 week ago

  • Work in company

    Senior Director, Drug Substance Development

    Only for registered members

    *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 Kardigan's mission to develop multiple targeted treatments in parallel that bring people with cardiovascular ...

    Princeton, NJ

    1 week ago

  • Work in company

    VP, Head of Drug Substance Development

    Only for registered members

    We have a cutting-edge discovery and translational research platform,a pipeline of late-stage candidates,and an industry-leading team that is driven to improve the lives of patients. · B.S.and M.S./Ph.D.in Organic Chemistry,Chemical Engineering, or a related scientific discipline ...

    Princeton $270,000 - $372,000 (USD)

    1 month ago

  • Work in company

    VP, Head of Drug Substance Development

    Only for registered members

    Kardigan is seeking an accomplished and forward-thinking, highly effective leader to serve as Vice President, Head of CMC Drug Substance Development. Reporting directly to the Chief Technical Operations Officer, this leader will build and oversee a best-in-class Chemical Developm ...

    Princeton, New Jersey, United States

    1 month ago

  • Work in company

    Senior Director, Drug Substance Development

    Only for registered members

    · 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 Kardigan's mission to develop multiple targeted treatments in parallel that bring people with cardiovascula ...

    Princeton, New Jersey, United States

    1 week ago

  • Work in company

    Associate Director, Drug Substance Development

    Only for registered members

    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 Kardigan's mission to develop multiple targeted treatments in parallel that bring people with cardiovascular d ...

    Princeton $202,000 - $263,000 (USD) Full time

    1 week ago

  • Work in company

    Sr. Director, Chemical Development

    Only for registered members

    The Senior Director Chemical Development will lead end-to-end drug substance development from early programs through commercial manufacturing. · This role owns API process strategy development scale-up supply leading high-performing teams overseeing external manufacturing partner ...

    Princeton $227,000 - $284,100 (USD)

    1 month ago

  • Work in company

    Therapist

    Only for registered members

    · About Us: · We are a leading provider of mental health and substance abuse treatment services, dedicated to transforming lives and communities through compassionate care and evidence-based practices. As a reputable organization committed to excellence, we are seeking compassio ...

    Princeton, New Jersey, United States $55,000 - $110,000 (USD) per year

    1 week ago

  • Work in company

    Behavioral Health Technician

    Only for registered members

    · About Us · We are a leading provider of mental health and substance abuse treatment services, dedicated to transforming lives and communities through compassionate care and evidence-based practices. As a reputable organization committed to excellence, we are seeking compassion ...

    Princeton, New Jersey, United States $32,000 - $52,000 (USD) per year

    1 week ago

  • Work in company

    Live in Case Manager

    Only for registered members

    · Live in Case Manager · About Us · We are a leading provider of mental health and substance abuse treatment services, dedicated to transforming lives and communities through compassionate care and evidence-based practices. As a reputable organization committed to excellence, we ...

    Princeton, New Jersey, United States

    2 days ago

  • Work in company

    Sr. Director, Chemical Development

    Only for registered members

    The Senior Director Chemical Development will lead end-to-end drug substance development from early programs through commercial manufacturing. · ...

    Princeton, NJ

    1 month ago

  • Work in company

    Clinical Lead Therapist

    Only for registered members

    · About Us · We are a Behavioral Health group specializing in substance use disorder and co-occurring issues. Our facility strives to provide the highest quality of care, using evidence-based treatment, medical staff, and licensed therapists. Our mission is to help those that ar ...

    Princeton, New Jersey, United States

    1 week ago

  • Work in company

    Director, Analytical Development

    Only for registered members

    Kardigan Bio is seeking a strategic and hands-on analytical leader to join our Analytical Development team within Technical Operations. · In this role, you will lead analytical development for small molecules and/or oligonucleotide programs, supporting late-phase development thro ...

    Princeton $199,000 - $259,000 (USD)

    1 month ago

  • Work in company

    Group Facilitator

    Only for registered members

    · Group Facilitator  · About Us · We are a leading provider of mental health and substance abuse treatment services, dedicated to transforming lives and communities through compassionate care and evidence-based practices. As a reputable organization committed to excellence, we a ...

    Princeton, New Jersey, United States $65,000 - $120,000 (USD) per year

    1 week ago

  • Work in company

    Sr Manager, MSAT, DSP

    Only for registered members

    The Manager/Senior Manager, Downstream MSAT, is an experienced and enthusiastic process engineer who will join a dynamic late-stage clinical and commercial environment working with our lead asset, · Ivonescimab. · The ideal candidate will have proven technical ability in overall ...

    Princeton $155,000 - $180,000 (USD)

    1 month ago

  • Work in company

    Application Developer

    Only for registered members

    The Application Developer - Beverages drives innovative processing development projects from concept to customer by creating, optimizing, and scaling recipes that balance cost, quality, and performance. This role sits at the heart of cross-functional collaboration—working hands-o ...

    Princeton $75,000 - $130,000 (USD) per year

    1 week ago

  • Work in company

    Partner Engagement Specialist

    Only for registered members

    About us: · Forge Health is a mission-driven outpatient mental health and substance use provider dedicated to providing the highest quality, affordable, and effective care to individuals, families, and communities in need. As the first and only behavioral healthcare provider with ...

    Princeton $60,000 - $100,000 (USD)

    2 days ago

  • Work in company

    Developer D&A

    Only for registered members

    Drives innovative processing development projects from concept to customer by creating optimizing and scaling recipes that balance cost quality and performance. · ...

    Princeton

    1 month ago

Jobs
>
Princeton