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Kardigan · 2 days ago

Director, Drug Substance Development

Princeton, New Jersey, United States

Full-time

Onsite

Director/Executive

$202K/yr - $263K/yr

10+ years exp

Kardigan is a heart health company focused on making cardiovascular disease preventable and curable. They are seeking a Director of Drug Substance Development to lead the implementation of manufacturing technologies and ensure compliance with regulatory requirements while supporting clinical and commercial product lifecycle management.

Artificial Intelligence (AI)BiopharmaHealth CareMedical

H1B Sponsor Likely

Responsibilities

Lead process and technology transfers, change management, and technical process support clinical and commercial Oligonucleotide and small molecule products

Owner of process control strategies including process risk assessments and process validation

Comprehensive data analyses using historical process experience and characterization studies to identify trends in process performance and drive changes in the process control strategy and risk assessments

Lead production related investigations, ensuring compliance with internal standards and regulatory requirements

Own process validation (PV) reports including process monitoring of manufacturing processes to understand process capability and performance drift over time

Provide necessary technical analysis to support impact assessments and investigations

Develop, execute and implement manufacturing process improvement activities in accordance with the overall life cycle plan for the product

Share operational and process learnings with the rest of the manufacturing network

Qualification

Oligonucleotide manufacturingSmall molecule manufacturingProcess validationRegulatory submissionsData analysisRisk assessmentCross-functional leadershipMS Office proficiencyStatistical software knowledgeTechnical writingProblem-solvingInterpersonal skillsDetail-oriented

Required

MSc, or BSc in Chemistry or equivalent with minimum of 10+ years of relevant experience

Familiarity with oligonucleotide/small molecule processes and cGMPs is preferred

Ability to effectively lead cross functional teams, meet deadlines, and prioritize responsibilities

Ability to assess risk and develop contingency plans for process risks

Experienced with small molecule & oligonucleotides drug substance programs

Experienced in purifying and drying unit operations intended for oligonucleotide products, filtration, ultrafiltration and chromatography technologies

Authored Technical Reports, Application Notes, Risk Assessments, & Protocols

Cultivate/ managed relationships with external partners to drive business objective

Experienced with Regulatory IND and NDA submissions

Designed and deployed standard work tools for data collection and interpretation, Advanced data management and statistical analysis skillset

Experience working in a self-driven, performance/results oriented, fast paced matrix environment

Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs

Able to manage time and elevate relevant issues to project lead and line management

Detail oriented with excellent verbal and written communication skills

Strong interpersonal and leadership skills to work with teams in different functions and organizations and CDMO's

Preferred

Experience with small molecule and/or oligonucleotides process characterization, control strategy, development and / or manufacturing

Supported NDA submission for small molecules and/or oligonucleotide programs

Experience with technology transfer in a manufacturing environment and PIP support

Proficiency utilizing MS Office products and working knowledge of statistical software JMP, Spotfire, Minitab)

10-15 years of experience in oligonucleotide or small molecule process development, MS&T, and/or manufacturing

Experience with commercial product support, i.e. post-marketing commitments, on-going validation and comparability

PhD in Organic chemistry

Company

Kardigan

Kardigan develops personalized medicines using AI and data to target and treat the root causes of cardiovascular diseases.

Founded in 2023

South San Francisco, California, USA

51-200 employees

https://www.kardigan.bio

H1B Sponsorship

Kardigan has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2025 (1)