G1 Therapeutics
  • Durham, NC, USA
  • Full Time

Primary Job Responsibilities:

Specific tasks/projects, skills, short and long-term objectives, management responsibilities, if any

  • ~50% Project Management
    • Management of contract manufacture of regulatory starting materials, GMP intermediates and API
    • Manage through G1 contractors, route selection, process development and optimization, scale up, and GMP manufacture of G1 clinical compounds
    • Review and approval of master batch records
    • Contribute to regulatory document preparation and review as requested
  • ~50% Laboratory Process Development
    • Explore alternate route of synthesis
    • Optimize existing routes of synthesis and isolations
    • Troubleshoot process issues that arise at contract manufacturers
    • Synthesis impurity markers and standards.
    • Document laboratory work in compliance with SOPs and regulatory requirements
    • Other duties as assigned

Job and Level Requirements:

Minimum education and experience required, also ideal but not required qualifications

  • MS or Ph D. degree in organic chemistry or chemical engineering with 5-7 years' experience in the pharmaceutical industry involving organic synthesis, process scale-up, or equivalent
  • Good working knowledge of cGMP regulations and comfortable working within ICH guidelines
  • Demonstrated ability to manage outsourced chemical development activities in a virtual environment both domestically and internationally
  • Excellent oral and written communication, organizational and planning skills are required
  • Problem solving skills
  • Organized, able to accept changes in work assignments, and ability to collaborate with others
  • Detail-oriented, a self- starter and comfortable with a broad scope of responsibilities in an entrepreneurial, fast-paced, small company environment
  • Able to work in and maintain a safe laboratory environment
  • Ability to travel up to 10%

G1 Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. G1 Therapeutics complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

G1 Therapeutics
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