Director, Biologics Analytical Development & Validation

Oruka Therapeutics; Waltham (MA); On-site; USD 213,000 - 240,000; Full time

Benefits offered by this job

competitive salary and benefits package

opportunities for professional growth

supportive and inclusive team environment

Job summary

Oruka Therapeutics in Waltham, MA, is hiring a Director of Analytical Development and Validation to lead strategic activities for biologic products. The role demands expertise in analytical method validation and collaboration across teams to ensure compliance and quality.

Ideal candidates will possess a Master’s or PhD with significant experience in the field, especially relating to monoclonal antibodies and PFS/Auto Injectors. Offers a competitive salary between $213,000 and $240,000, alongside benefits and a supportive culture.

Qualifications

• 10+ years of experience with monoclonal antibodies or 7+ years with a PhD.
• Experience in method development, qualification, validation and method transfer.
• Deep understanding of ICH guidelines and regulatory expectations for biologics.

Responsibilities

• Lead analytical development activities and oversee validation processes.
• Collaborate with CMC, Quality, and Regulatory teams.
• Drive analytical strategies and manage technical oversight of CDMOs.

Skills

monoclonal antibodies

PFS/Auto Injectors

analytical method validation

communication skills

people management

Education

Master’s degree or PhD in a scientific discipline

Tools

U/HPLC

Capillary Electrophoresis

Spectrophotometer

Bioassay (ELISA and Cell-Based)

Job description

Oruka Therapeutics in Waltham, MA, is hiring a Director of Analytical Development and Validation to lead strategic activities for biologic products. The role demands expertise in analytical method validation and collaboration across teams to ensure compliance and quality.

Ideal candidates will possess a Master’s or PhD with significant experience in the field, especially relating to monoclonal antibodies and PFS/Auto Injectors. Offers a competitive salary between $213,000 and $240,000, alongside benefits and a supportive culture.