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Form of work About Kronos Bio
Kronos Bio, Inc. is dedicated to the discovery and development of first-in-class therapies that modulate historically undruggable targets. We leverage deep capabilities in high-throughput small molecule microarrays (SMM), targeted protein degradation, and cancer biology in order to identify potent and selective compounds against transcription factors and other central drivers of oncogenic signaling.
Summary of Position:
Kronos Bio is seeking a highly motivated Manager, Chemical Development with cGMP API process chemistry to join the Pharmaceutical, Development and Manufacturing (PDM) team. This position is responsible for managing the drug substance process development and manufacturing activities. This position will be an integral part of the Company's effort to discover and develop first-in-class therapies that modulate historically undruggable target.
Essential Duties and Responsibilities :
Desired Experience :
The expected annual salary range for this full-time position is $115,000 - $130,000, plus eligibility for bonus, benefits, and equity incentives. Actual pay will be determined based on experience, qualifications, business needs, internal equity, and alignment with market data.
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Kronos Bio, Inc. is dedicated to the discovery and development of first-in-class therapies that modulate historically undruggable targets. We leverage deep capabilities in high-throughput small molecule microarrays (SMM), targeted protein degradation, and cancer biology in order to identify potent and selective compounds against transcription factors and other central drivers of oncogenic signaling.
Summary of Position:
Kronos Bio is seeking a highly motivated Manager, Chemical Development with cGMP API process chemistry to join the Pharmaceutical, Development and Manufacturing (PDM) team. This position is responsible for managing the drug substance process development and manufacturing activities. This position will be an integral part of the Company's effort to discover and develop first-in-class therapies that modulate historically undruggable target.
Essential Duties and Responsibilities :
- 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.
- This position reports directly to the Senior Manager, Chemical Development.
Desired Experience :
- 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.
The expected annual salary range for this full-time position is $115,000 - $130,000, plus eligibility for bonus, benefits, and equity incentives. Actual pay will be determined based on experience, qualifications, business needs, internal equity, and alignment with market data.
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
