Associate Director, Technical Operations (Analytical Development-Biologics)

Scorpion Therapeutics; United States; Remote; USD 150,000 - 210,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director, Technical Operations specializing in analytical development for biologics in a rare disease biopharma setting. You will lead method development, validation, transfer, and specification setting to support late-stage programs.

Responsibilities include authoring validation protocols, managing reference standards, reviewing batch records and CoAs, supporting root cause investigations, and contributing to regulatory submissions in a global

Qualifications

• B.S. in chemistry, biochemistry, or related field.
• 8+ years in biologics analytical development.
• Hands-on experience with HPLC, CE-SDS, cIEF, LC-MS, and bioassays.
• Familiar with PEGylated or lyophilized products.

Responsibilities

• Author validation protocols for analytical methods.
• Manage reference standards and materials.
• Review batch records and CoAs for accuracy.
• Support root cause investigations.
• Contribute to regulatory submissions.

Skills

Project management

Cross-functional collaboration

Regulatory knowledge

Communications

Analytical thinking

Education

Bachelor's degree in Chemistry or Biochemistry

Tools

HPLC

CE-SDS

cIEF

LC-MS

Bioassays

Job description

Role:

Associate Director, Technical Operations, specializing in analytical development for biologics in a rare disease biopharma setting.

Primary objectives:

Primary objectives include leading method development, validation, transfer, and specification setting at CDMOs/CROs, ensuring compliance with cGMP, FDA, ICH, and EU standards.

Responsibilities:

Responsibilities encompass authoring validation protocols, managing reference standards, reviewing batch records and CoAs, supporting root cause investigations, and contributing to regulatory submissions.

Requirements:

Requirements: B.S. in chemistry, biochemistry, or related field; 8+ years in biologics analytical development, with hands-on experience in HPLC, CE-SDS, cIEF, bioassays, LC-MS, and familiarity with PEGylated or lyophilized products.

Preferred skills:

Preferred skills include strong project management, knowledge of global GMPs, and effective cross-functional collaboration.

HighValue:

HighValue: biologics, late-stage drug development, regulatory compliance, process transfer, and analytical method validation.

WorkSetup:

WorkSetup: remote with 10-20% domestic/international travel.