Associate Director, CMC Analytical

ASSOCIATE DIRECTOR, CMC ANALYTICAL

Position Summary:

The Associate Director will be responsible for the analytical activities related to the commercial manufacturing of drug substance and drug product at the CMOs. Such activities include setting specifications, reference standard qualification, analytical change controls, QC release testing and stability studies.

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.

Essential Duties and Responsibilities:

• Manage the CMO activities and timelines in a team setting
• Critical review of analytical method transfers documents and release/ stability data package for drug substance and drug product
• Author and review the analytical technical reports
• Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings.
• Other responsibilities will include material specifications and change controls
• Participate in the CMC strategic planning

Qualifications:

• Doctoral degree in chemistry, pharmaceutical sciences, or related discipline, and minimum 10 years of experience, or MS/BS degrees with minimum 15 years of experience in the small molecule pharmaceutical industry.
• Sensitive to timelines and solution oriented
• Thorough understanding of cGMPs, USP and ICH guidelines and industry best practices
• Familiar with the current analytical techniques for pharmaceutical development
• Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices.
• Excellent written and verbal communication skills.

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
• Flexibility
• Integrity

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.