Associate Director

Company: G1 Therapeutics, Inc
Location: Raleigh
Posted on: May 3, 2021

Job Description:

Director/Assoc. Director, Analytical DevelopmentG1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the development and delivery of innovative therapies that improve the lives of those affected by cancer. This includes the Company's first commercially available product COSELA (trilaciclib), a first-in-class proactive multilineage myeloprotection therapy approved by the U.S. Food and Drug Administration to help protect against chemotherapy-induced myelosuppression in patients with extensive-stage small cell lung cancer being treated with chemotherapy. COSELA is also being evaluated in other solid tumors, including colorectal, breast, bladder and non-small cell lung cancers.G1 Therapeutics is currently recruiting an Associate Director or Director of Analytical Development to join our team in RTP Location. Responsibilities: Manage Drug Substance and Drug Product analytical activities for a clinical and commercial small molecule product.Manage all analytical CMO interactions to support product (method development, method validation, transfer, release testing, stability programs, etc.).Develop specifications for Drug Substance and Drug ProductReview protocols/data/reports for method validation, transfer, batch release, and stability activities.Manage internal and external analytical investigations.Prepare regulatory documents for submission as requested.Support and execute internal/external analytical activities, as appropriate.Other duties as assigned by supervisor. Requirements: The candidate must have a PhD degree in chemistry or analytical chemistry with 5-7 years' experience, or an MS degree with up to 5 years' experience in the pharmaceutical industry. Relevant work in analytical chemistry including significant laboratory experience or experience deemed equivalent is required.Good working knowledge of cGMP regulations and comfortable working within ICH guidelines.Demonstrated ability to manage globally outsourced analytical development activities.Experience with late phase analytical support a plus.Strategic view and leadership abilities as well as hands-on problem-solving skills.Excellent oral and written communication, organizational and planning skills are required.Detail-oriented, a self- starter and comfortable with a broad scope of responsibilities in an entrepreneurial, fast-paced, small company environment.Quality and project management experience is a plus.Ability to travel up to 15%. Why Join Us? We know our employees are our most valuable asset, and our culture conveys that. All employees are issued laptops, and our office staff all have height-adjustable desks, access to a stocked kitchen, and multiple employee events throughout the year. We also offer a competitive benefits package, including generous PTO, to support the health and happiness of our staff. An Equal Opportunity Employer G1 Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at G1 Therapeutics are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.Do you now, or will you in the future, require sponsorship (e.g., H-1B visa status, etc.) to work legally for G1 Therapeutics in the United States?*This role will be located at our HQ in Research Triangle Park, NC. Hired candidate must either live in this area or be willing to relocate at future date.*Do you have at least 3 years working experience within a pharmaceutical or biotech company in Analytical Development?*Do you have a PhD and/or MS degree in chemistry or analytical chemistry?*SDL2017

Keywords: G1 Therapeutics, Inc, Raleigh , Associate Director, Other , Raleigh, North Carolina