Senior Manager, Chemical Development
SENIOR MANAGER, CHEMICAL DEVELOPMENT
The Senior Manager, Chemical Development will be responsible for the design, development and implementation of robust synthetic processes to support small molecule programs with the goal of delivering preclinical, clinical, and commercial drug substance batches meeting program needs. The candidate will report to the head of Chemical Development in Technical Operations.
Global Blood Therapeutics (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:
- Design, develop, and implement robust chemical processes for starting materials, intermediates, and APIs for research and development programs
- Support technical transfer of starting material, intermediate or API processes between sites as needed
- May manage and mentor junior scientists in process development and professional development
- Function as a highly effective communicator and team player in a dynamic team culture
- 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
- Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product programs and vendors
- Critical review of proposals from CROs or CMOs; perform appropriate due diligence as needed to ensure CROs and CMOs 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
- BS/MS/PhD. in synthetic organic chemistry, minimum of 8 years of experience in the small molecule pharmaceutical industry
- Laboratory experience required
- Hands-on experience with different stages of drug substance development
- Chemical development experience with chiral molecules and chiral crystallizations preferred
- Thorough understanding of the synthetic and analytical techniques necessary for proper polymorph screening, optimization, and patent protection
- Thorough understanding of cGMPs, ISO, and ICH guidelines, and industry best practices
- Experienced in Design of Experiments (DOE) and Quality by Design (QbD) principles
- Commercial manufacturing or clinical manufacturing experience preferred
- Experienced overseeing manufacturing at CMO sights preferred.
- Experienced in working with 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.