The Manager/Senior Manager will act as the liaison between Global Blood Therapeutics (GBT) CMC Analytical and the CMO Analytical/Quality Control. His/her main responsibilities include interacting with CMOs for method development, method transfer, method validation, release testing, stability studies, and investigations. These analytical activities may be for starting materials, intermediates, drug substance or drug product.
GBT places a high value on cooperative team dynamics and a positive, “can-do” work ethic. The ideal candidate thrives in a fast-paced environment where a strong sense of urgency is the norm and exceptional communication and interpersonal skills are needed.
• Actively manage analytical development and quality control programs for drug substances and /or drug product manufacturing at CMOs.
• Review the method transfer/validation protocols/ reports and stability study protocols/ reports,
• Critical review of analytical release and stability data for drug substances and drug products
• Other responsibilities will include material specifications, deviation reports, and change controls
• BS or MS degree in chemistry, pharmaceutical sciences, or related discipline, and minimum 10 years of experience in the small molecule pharmaceutical industry.
• Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices.
• Excellent written and verbal communication skills.
• Experiences on both drug substances and solid oral dose drug products are preferred
• Validation experience required and early commercial experience strongly desired.
Drive, desire, motivation:
• Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues
• Comfortable executing on multiple projects independently.
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
• Excitement about the vision and mission of GBT
• Values-based leadership