Research Scientist II, Chemical Development
RESEARCH SCIENTIST II, CHEMICAL DEVELOPMENT
Research Scientist in Chemical Development will be responsible for the design and execution of various experiments to support process development and project goals of small molecule programs. The candidate will report to Director, Chemical Development.
GBT places a high value on cooperative team dynamics and a positive, “can-do” work ethic. The ideal candidate thrives in a hands-on, fast-paced environment where a strong sense of urgency and accountability is the norm and exceptional communication and interpersonal skills are needed.
Essential Duties and Responsibilities:
- Plan and execute assigned experiments that support process development activities and project goals
- Maintain safe working environment and EHS compliance
- Identify reactions and processes that are not suitable for scaleup and address those issues with alternate approaches
- Design, develop and implement robust chemical synthesis processes for starting materials, intermediates and APIs for research and development programs
- Support technical transfer of starting material, intermediate and API processes between sites as needed
- Manage and mentor junior scientists and support their professional development
- Perform phase appropriate process R&D to support both early stage and late stage programs
- Perform fate and tolerance studies, genotoxic impurity evaluation and establish the framework for the control strategy of the drug substance from early development with a long-term vision of the commercial process
- Maintain high level of expertise through familiarity with scientific literature and by attending scientific trainings, conferences and courses
- Critical review of proposals from CMOs and CROs; perform appropriate due diligence as needed to ensure CMOs and CROs can support the requirements of individual chemical development programs effectively
- Support PAR studies and pre-validation and validation activities for drug substance
- Author relevant CMC sections for US and ex-US regulatory filings as needed
- Up to 25% travel will be needed for scientific project management and monitoring of critical project activities
- PhD. in synthetic organic chemistry with minimum 3 years of experience, or BS/MS degree with minimum of 10 years of industry experience in developing small molecule pharmaceuticals Laboratory experience required
- Chemical development experience with synthesis and crystallizations of chiral molecules preferred
- Thorough understanding of the synthetic and analytical techniques necessary for proper polymorph screening, optimization and patent protection
- Good understanding of cGMP, ISO and ICH guidelines and industry best practices
- Experience and understanding of Design of Experiments (DOE) and Quality by Design (QbD) principles
- Experience in clinical and/or commercial manufacturing
- Experience in managing and overseeing development and manufacturing activities at CMOs and CROs
Fit with GBT culture:
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
- Values-based leadership consistent with GBT's Core Values
- Excitement about the vision and mission of GBT
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.