Senior Manager/Associate Director, Analytical Development & QC
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:
This position will be responsible for planning and executing product characterization (from raw materials to regulatory starting materials, GMP intermediates, active pharmaceutical ingredients, bulk and finished products), analytical method development, validation, test method transfers to contract QC and development labs, and oversight of GMP in-process, release, and stability testing. This role will be critical in supporting clinical studies and regulatory submissions by designing product characterization and stability studies, generating relevant documentation, authoring product specifications, overseeing the development of test methods, and drafting sections of regulatory filings. The role requires creativity and technical expertise to resolve complex technical challenges through collaboration with the chemical development, manufacturing, and formulation teams. The individual in this position will serve as a collaborator and a scientific and technical leader on a variety of teams within the company and will represent the company during interactions with regulatory agencies, partners, and vendors.
Essential Duties and Responsibilities:
- Collaboration with formulation and chemical development in process and product control strategies
- Creation and justification of product analytical control strategies and specifications
- Oversight of analytical development and QC testing of Kronos products performed at contract facilities:
- Analytical method development, optimization, transfer, and qualification/validation
- Product characterization
- Quality control testing (cGMP and non-GMP)
- Provision of technical guidance and troubleshooting to contract facilities
- Review and approval of analytical data and documentation, including (but not limited to) development studies, stability studies, method transfer/qualification/validation, COAs, investigations, and sampling plans
- Author technical reports and relevant CMC sections to support IND/IMPD and NDA/MAA filing.
- Provide scientific/technical guidance to inform decision-making across the company, including non-analytical functions, as appropriate
- Communicate cross-functionally to enhance development team cohesiveness and to promote appropriate project support
- Represent analytical development and QC in project teams, product development teams, company initiative task forces, and collaborations with partners as the analytical development SME
- Travel to external analytical development and QC labs as required
- Degree in chemistry, chemical engineering, biochemistry, pharmaceutical sciences, or related field: Ph.D. with 7+ years, MS/BS with 10+ years, of relevant analytical chemistry experience in biotechnology or pharmaceutical industry
- A broad understanding of analytical method development for small molecule drug substances and products
- Demonstrated ability to manage test method validation and transfer
- Demonstrated technical proficiency of analytical methodologies for pharmaceutical characterization and QC testing
- Proven ability to lead in a team environment to solve complex technical challenges
- Fluency in ICH, FDA, and EMA guidelines and experience in creating control strategies in accordance with regulatory expectations
- Experience in authoring regulatory submissions and responding to health authority queries
- Knowledge of relevant GMP and quality guidelines
- Ability to effectively represent Kronos with external partners
- Excellent oral and written communication skills
- Embodies 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 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.