Associate Director, Technical Operations (Analytical Development-Biologics)

Scorpion Therapeutics; United States; On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health

Retirement match

Life insurance

Generous PTO

Job summary

Scorpion Therapeutics is seeking an Associate Director, Technical Operations to lead analytical operations for a biologics product, serving as SME and ensuring cGMP compliance. You will oversee method development, validation, transfer, and reference standard programs at CDMOs/CROs, review CoAs, and support regulatory submissions.

Onsite in San Diego with travel up to 20%, competitive compensation. The role requires 8+ years in analytical development for biologics and strong knowledge of HPLC,

Qualifications

• B.S. in chemistry/biochemistry/pharmaceutical science or related life sciences required; M.S. preferred.
• 8+ years analytical development experience for biologics (late-stage preferred).
• Knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS; PEGylated/lyophilized products a plus.
• Experience reviewing analytical data and managing development at external CDMOs/CROs.

Responsibilities

• Manage analytical method development, validation, and transfer for biologics products.
• Oversee specification setting for drug substance and drug product at CDMOs/CROs.
• Author/review validation protocols/reports, transfer protocols/reports, and SOPs.
• Manage reference standard program for drug substance and drug product.
• Review controlled documents like batch records and CoAs.
• Assist in OOS/OOT investigations and root cause analyses.
• Serve as SME for regulatory submissions (analytical packages, characterization).
• Provide scientific support to internal/external groups to ensure compliant manufacturing and release.

Skills

Analytical development

Regulatory knowledge

Communication

Cross-functional teamwork

Problem solving

Education

B.S. in chemistry/biochemistry/pharmaceutical science or related life sciences

M.S. preferred

Tools

HPLC

CE-SDS

cIEF

Potency bioassays

Peptide mapping

ELISA

LC-MS

Job description

Position Summary

The Associate Director, Technical Operations is responsible for the analytical operations of a biologics product and serves as an analytical subject matter expert. Oversees analytical method development, validation, and transfer in compliance with cGMP and international regulatory standards.

Responsibilities

• Manage and oversee analytical method development, validation, and transfer for biologics products at CDMOs/CROs.
• Oversee specification setting for drug substance and drug product at CDMOs/CROs.
• Author/review analytical method validation protocols/reports, method transfer protocols/reports, and SOPs.
• Manage reference standard program for drug substance and drug product.
• Review controlled documents (e.g., batch records and CoAs).
• Assist in OOS/OOT investigations; perform root cause analyses and recommend corrective actions.
• Serve as technical subject matter expert for regulatory submissions (analytical package, characterization, reference standard).
• Provide scientific/technical support to internal and external groups to ensure compliant manufacturing and release.

Education/Experience Requirements

• B.S. in chemistry/biochemistry/pharmaceutical science or related life sciences required; M.S. preferred.
• 8+ years analytical development experience for biologics (preferably late-stage).
• Knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS; experience with PEGylated and/or lyophilized products is a plus.
• Experience reviewing analytical data and managing analytical development at external CDMOs/CROs.

Additional Skills/Experience

• Knowledge of US/EU GMPs, USP, Ph. Eur, and ICH guidelines.
• Ability to adapt to project changes; strong communication, interpersonal, organization, and collaboration skills.
• Ability to manage complex project plans, timelines, budgets, and critical path tasks.
• Travel 10-20%; role not expected to be 100% remote; onsite/face-to-face in San Diego required.

Benefits

• Premium health and financial/work-life/well-being offerings, life insurance, disability, retirement match, and generous paid time off.

Compensation

• Target base pay range: $150,000.00-195,000.00.