Director, Head of Analytical

Location
San Francisco, CA, United States
Posted
Jan 12, 2021
Ref
975
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
DIRECTOR, HEAD OF ANALYTICAL

Position Summary:

The Head of Analytical will be responsible for the in-house analytical method development and stability studies, and analytical activities related to the manufacturing of drug substance and drug product for clinical use at the CMOs. Such CMO analytical activities include setting specifications, reference standard qualification, analytical change controls, 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:

  • Provide analytical leadership to CMOs and manage their analytical activities and timelines
  • Manage a group of GBT analytical scientists and managers and their deliverables
  • Manage the in-house analytical development activities and technical reports
  • Perform critical review of analytical study protocols and reports
  • Responsible for authoring, review, and adjudication of analytical related CMC sections for US and ex-US regulatory filings
  • Participate in the CMC strategic planning
  • Responsible for analytical budget and expenses


Qualifications:

  • Doctoral degree in chemistry, pharmaceutical sciences, or related discipline, and minimum 10 years of experience, or MS/BS degrees with minimum 10 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
  • Good understanding of the work flow for drug substance and drug product manufacturing
  • Familiar with the current analytical techniques for pharmaceutical development
  • 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.