Associate Scientist, CMC Analytical

Location
San Francisco, CA, United States
Posted
Sep 20, 2019
Ref
698
Hotbed
Biotech Bay
Required Education
Associate Degree
Position Type
Full time
ASSOCIATE SCIENTIST, CMC ANALYTICAL

Position Summary:

The Associate Scientist is responsible for analytical development in support of process research and formulation development as well as, oversee quality control at CDMO. In addition, to support preparation of regulatory submissions.

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:
  • The Senior Research Associate/Associate Scientist, CMC Analytical is responsible for conducting scientific research for the analytical development of small molecule drug candidates
  • Plans, designs and implements laboratory experimentation for analytical method development, validation, release and stability testing for starting materials, drug substance intermediates, drug substance and finished drug product
  • Managing projects at CDMOs. Works closely with internal customers, CMOs and external vendors/contractors to ensure analytical deliverables are met per the project timelines
  • Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work
  • Oversee planning, execution, review, and trending of stability testing at CMO
  • Has a strong grasp of the underlying science but able to take on additional operational responsibilities because of talent and indicated interest
  • Serves as a resource to management on the operational strategy of the research function and provides long term resource planning for equipment, laboratory space and staffing levelS

Qualifications:
  • Bachelor' s degree in Chemistry, Pharmaceutical Sciences or related field with minimum 5 years of pharmaceutical industry experience
  • Operational knowledge of analytical instrumentation like HPLC and KF as well as data processing. Demonstrates emerging ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes
  • Solid dosage dissolution method development and troubleshooting experience
  • Experienced in working with CMOs and CROs
  • Thorough understanding of cGMPs and ICH guidelines
  • Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills
  • Excellent scientific and business communication skills (both verbal and technical) are required
  • Excellent interpersonal skills are required

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.