Associate Director Analytical Development & Quality Control

Scorpion Therapeutics; South San Francisco (CA); On-site; USD 170,000 - 200,000; Full time

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.

Skills

Data interpretation

Vendor negotiation

Cross-functional collaboration

Travel readiness

Education

PhD or advanced degree in Chemistry/Pharmaceutics

Tools

HPLC

GC

NMR

MS

Solid-state characterization

Job description

Role: Associate Director of Analytical Development & Quality Control

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

Requirements

• 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, plus techniques like GC, NMR, MS, and solid-state characterization
• solid 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

High-Value: focus on late-stage analytical development, stability programs, regulatory documentation, and cross-functional leadership in a biotech setting.

WorkSetup: on-site South San Francisco; salary $170,000-$200,000.