Senior Director, Analytical Development & QC

Scorpion Therapeutics

South San Francisco (CA)

On-site

USD 170,000 - 200,000

Full time

5 days ago

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Job summary

Scorpion Therapeutics is seeking an Associate Director of Analytical Development & Quality Control to lead method development, validation, and stability studies. You will manage reference standards, stability programs, and regulatory documentation, while collaborating with vendors and internal teams to implement phase-appropriate analytical strategies.

You will contribute to CMC sections of regulatory filings and scientific publications, while monitoring project progress and ensuring timely

Qualifications

PhD or advanced degree in Chemistry, Pharmaceutics, or related field.
7+ years (PhD) or 10+ years (BS/MS) industry experience in small molecule development.
Expertise in HPLC and related techniques (GC, NMR, MS) and solid-state characterization.
Strong understanding of cGMP, ICH guidelines, validation, and stability management.
Strong data interpretation, vendor negotiation, and cross-functional collaboration skills.
Willingness to travel domestically and internationally.

Responsibilities

Lead method development, validation, stability studies, and data review.
Manage reference standards, stability programs, and regulatory documentation (IND/IMPD/NDA/MAA).
Collaborate with vendors and internal teams to ensure phase-appropriate analytical strategies.
Contribute to CMC sections of regulatory filings and scientific publications.
Monitor project progress and ensure timely completion.