Associate Director, Drug Substance Development en Kardigan

Position Title: Associate Director, Drug Substance Development (Director-level candidates welcome to apply) 

Department:  Technical Operations - Drug Substance

Reports To: Vice President, Head of Drug Substance

Location: Princeton, NJ – On-site 4 days per week (Mon to Thurs)

Job Overview

Kardigan Bio is looking for a Associate Director/Director to join the Drug Substance team within the Technical Operations department. The Associate Director will be responsible for the implementation of oligonucleotide and small molecule manufacturing technologies, including cross-departmental collaboration to enable facility fit, development of process documentation (global guidance documents, process control strategies, process risk assessments, etc), inspection readiness, and technical regulatory submissions.  This role will support clinical and commercial product lifecycle management, including authoring technical assessments and monitoring process performance including, but not limited to, continued process verification. The role collaborates across all CMC functional areas to ensure project advancement, rapid and best in class execution, and communication of challenges/opportunities.

Essential Duties and 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
  
  

Basic Qualifications

• MSc, or BSc in Chemistry or equivalent with minimum of 15+ 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.

Qualifications and Preferred Skills

• Experience with oligonucleotide /small molecule process characterization, control strategy, development and / or manufacturing.
• Supported and/or NDA submission for oligonucleotide, and small molecule 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.