Director, Biologics Analytics & Validation — Tech Ops

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

Benefits offered by this job

Equity

Bonus program

Growth opportunities

Startup culture

Job summary

Oruka Therapeutics in Waltham, MA is seeking a Director of Analytical Development and Validation for Tech Ops (Biologics). This hybrid role combines scientific leadership with strategic oversight of late-stage analytical activities supporting biologics development and lifecycle management, with a focus on monoclonal antibodies.

The successful candidate will lead method validation and comparability efforts for regulatory submissions, while partnering with CMC, Quality, and Regulatory Affairs, and

Qualifications

• Experience with monoclonal antibodies and PFS/Auto Injectors is required.
• Director: Master’s degree with 10+ years or PhD with 7+ years of relevant experience.
• Experience in method development, qualification, validation and transfer for biologics.

Responsibilities

• Lead late-stage analytical development activities for biologics including method transfer and validation.
• Provide SME for ICH Q2/Q14, USP/EP/JP and global regulatory expectations for analytical methods.
• Oversee validation of assays including potency/bioassays, purity and impurities and device tests.
• Drive analytical strategies to support BLA/MAA submissions and comparability studies.
• Build and mentor a high-performing analytical development team.

Skills

Monoclonal antibodies

PFS/Auto Injectors

Analytical method development

Method validation

Education

Master’s degree in a scientific discipline

PhD in a relevant field

Tools

UHPLC

Capillary Electrophoresis

Spectrophotometer

Bioassay (ELISA)

Job description

Oruka Therapeutics in Waltham, MA is seeking a Director of Analytical Development and Validation for Tech Ops (Biologics). This hybrid role combines scientific leadership with strategic oversight of late-stage analytical activities supporting biologics development and lifecycle management, with a focus on monoclonal antibodies.

The successful candidate will lead method validation and comparability efforts for regulatory submissions, while partnering with CMC, Quality, and Regulatory Affairs, and