Manager, Chemical Development

Kronos Bio is seeking a Manager, Chemical Development with cGMP API process chemistry to join their Pharmaceutical, Development and Manufacturing team. The role involves managing drug substance process development and manufacturing activities, overseeing contract research organizations and contract manufacturing organizations, and authoring technical reports and relevant CMC sections to support IND/IMPD and NDA/MAA filing. The ideal candidate should have a PhD in Organic Chemistry, Chemical Engineering, or a related field, proficiency in synthetic organic chemistry, and familiarity with current manufacturing processes and equipment used in chemical development and validation. The expected annual salary range for this full-time position is $115,000 - $130,000.

• Responsible for oversight of contract research organizations (CROs) and contract manufacturing organizations (CMOs), conducting phase-appropriate development activities for starting materials, intermediates, and drug substance (DS). Activities include tech transfer, process scale-up/optimization, impurity identification & characterization, and process validation.
• Oversee DS manufacturing activities by reviewing and approving batch records and associated documentation. Work closely with ADQC and QA to ensure on-time delivery of DS to support ongoing clinical programs.
• Author technical reports and relevant CMC sections to support IND/IMPD and NDA/MAA filing.
• Apply working knowledge with regulatory/cGMP requirements to CMC development strategy and chemical development, and effectively communicate to functional groups across all levels of the organization and competent authorities.
• Involves travel to CROs/CMOs for the oversight of critical development activities and manufacturing where appropriate.

• PhD in Organic Chemistry, Chemical Engineering, or related field or MS with 3+ years of relevant experience in industrial chemical development and/or drug substance manufacturing.
• Proficiency in synthetic organic chemistry.
• Familiarity with current manufacturing processes and equipment used in chemical development and validation.
• Previous experience in small-molecule DS manufacturing is highly desired.
• Expertise with drug substance solid forms and characterization of physical and chemical properties is highly desired.
• Prior experience with managing CROs/CMOs is a plus.
• Experience with process characterization studies (OVAT/DOE) to identify potentially critical process parameters and establish prove acceptable ranges (PARs) of critical process parameters (CPPs) is a plus.
• Strong knowledge and demonstrated practice of broad array of chemical processing equipment, including familiarity with supporting analytical instrumentation such as pH meters, HPLC, UV/Vis spectroscopy, Karl Fischer, etc. and their application.
• Ability to thrive in a small group setting, developing and maintaining collaborative internal and external relationships.
• Good communication and presentation skills, effective project and time management skills.
• Motivated, self-directed, able to work autonomously, and a proven ability to work in a team environment.
• Embody Kronos values; exhibits high degree of integrity and professionalism when interacting with outside investigators and vendors.
• Entrepreneurial and enjoys working in a fast-paced, creative and resourceful small company environment.