Associate Director, Analytical Development

Scorpion Therapeutics; United States; On-site; USD 160,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks an Associate Director, Analytical Development to drive CMC analytical development for small-molecule DS/DP and to support mid- and late-phase clinical programs in collaboration with CDMOs.

You will develop and validate analytical methods, manage impurity programs, and oversee stability studies while preparing regulatory documents and addressing agency questions. Strong cGMP/GLP knowledge is required.

Qualifications

• PhD in Analytical Chemistry or related field preferred; 10+ years CMC analytical development experience for small-molecule DS and oral solid dosage forms.
• Impurity control strategy experience (PMIs, nitrosamines)
• Late-phase method development/validation/transfer and small-molecule characterization expertise
• Expertise with HPLC (UV/RID/ELSD/CAD), GC, MS, NMR, XRPD, DSC/TGA, KF, particle sizing, dissolution
• Knowledge of USP/EP compendial DS/DP testing
• Ability to design/implement/manage cGMP DS/DP stability studies at external labs
• Working knowledge of GLP, cGMP, and ICH; NDA/MAA analytical writing experience a plus

Responsibilities

• Execute development and validation of analytical methods for DS/DP.
• Ensure analytical methods, control strategies, and specifications are robust for Phase 3 to commercial readiness.
• Characterize DS/DP-related impurities and review analytical testing results.
• Design and monitor ICH stability programs for DS and DP.
• Manage day-to-day analytical development/testing activities at CDMOs and contract test labs.
• Implement and operate analytical capabilities in the internal lab.
• Prepare/review GMP documentation, analytical data and technical reports; support investigation of nonconformances.
• Author/review analytical sections of late-phase regulatory submissions (IND/IMPD/NDA/MAA).
• Support health authority interactions and responses to agency questions.
• Ensure analytical approaches meet global regulatory expectations and inspection readiness.

Skills

CMC analytical development

Impurity control strategy

Late-phase method development

Analytical method transfer

Education

PhD in Analytical Chemistry or related field

Tools

HPLC (UV/RID/ELSD/CAD)

GC

MS

NMR

XRPD

DSC/TGA

KF

Dissolution testing

USP/EP DS/DP testing

Job description

How you’ll make an impact:

As the Associate Director, Analytical Development, you will contribute to CMC activities supporting mid and late phase clinical development of Kymera’s small-molecule protein degraders, in partnership with CDMOs.

• Execute development and validation of critical analytical methods (achiral/chiral HPLC, GC, IC, dissolution, and assays for potentially mutagenic impurities (PMIs) and nitrosamine impurities)
• Ensure analytical methods, control strategies, and specifications are robust and validated for Phase 3 to commercial readiness
• Characterize DS/DP-related impurities (including formation/purging) and review analytical testing results
• Design and monitor ICH stability programs for DS and DP
• Manage day-to-day analytical development/testing activities at CDMOs and contract test labs
• Implement and operate analytical capabilities in the internal lab
• Prepare/review GMP documentation, analytical data and technical reports; support investigation of nonconformances (OOS/OOT, deviations)
• Author/review analytical sections of late-phase regulatory submissions (IND/IMPD/NDA/MAA)
• Support health authority interactions and responses to agency questions
• Ensure analytical approaches meet global regulatory expectations and inspection readiness

Skills and experience you’ll bring:

• PhD in Analytical Chemistry or related field preferred; 10+ years CMC analytical development experience for small-molecule DS and oral solid dosage forms
• Impurity control strategy experience (PMIs, nitrosamines)
• Late-phase method development/validation/transfer and small-molecule characterization expertise
• Expertise with HPLC (UV/RID/ELSD/CAD), GC, MS, NMR, XRPD, DSC/TGA, KF, particle sizing, dissolution
• Knowledge of USP/EP compendial DS/DP testing
• Ability to design/implement/manage cGMP DS/DP stability studies at external labs
• Working knowledge of GLP, cGMP, and ICH; NDA/MAA analytical writing experience a plus

Compensation:

Anticipated base salary range: $160,000–$240,000; eligibility for annual bonus, equity participation, and comprehensive benefits.