Associate Director, Formulation Development, Tech Ops – Biologics

Oruka Therapeutics

. Lead phase-appropriate formulation development workflows for biologics, including selection, optimization, and robustness studies, focusing on high-concentration products .

Posted 11/5/2026full-timeWaltham • Massachusetts • United StatesSenior💰 $182,000 - $208,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in phase-appropriate formulation development for biologics, including monoclonal antibodies and co-formulations, with a strong focus on regulatory compliance and technical oversight. Proven ability to lead teams, manage technical direction, and collaborate effectively with cross-functional partners in a fast-paced environment.

Highest-signal resume keywords

Formulation DevelopmentMonoclonal AntibodiesRegulatory FilingsU/HPLCTechnical Oversight

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Formulation DevelopmentContainer Closure SelectionRobustness StudiesU/HPLCCapillary ElectrophoresisSpectrophotometryBioassayDevice Functional TestingComparability StudiesTech Transfer

Soft Skills

Excellent WritingOrganizationCommunicationPeople ManagementCreative Mindset

Certifications & Qualifications

Master's DegreePhD

Industry Keywords

BiologicsPhase-Appropriate DevelopmentBLA/MAA SubmissionsLifecycle ManagementRegulatory InteractionsCDMO ManagementCommercial Launch ReadinessPFS/Autoinjector StudiesStability StudiesPost-Approval Changes

About the role

Key responsibilities & impact

Lead phase-appropriate formulation development workflows for biologics, including selection, optimization, and robustness studies, focusing on high-concentration products
Lead formulation development and container closure selection for monoclonal antibodies, bispecific formats, and co-formulations
Partner with drug product and clinical teams on container closure selections aligned with QTPP and clinical needs
Design and execute in-use compatibility studies for subcutaneous administration of high-concentration biologics
Partner with analytical development to verify assays are not impacted by formulation changes
Drive formulation strategies supporting robustness and comparability studies, BLA/MAA submissions, and post-approval changes
Partner with Process Development, Manufacturing, Quality, and Regulatory on late-stage development, tech transfer, and commercial launch readiness
Support formulation risk assessments, control strategy development, and lifecycle management
Serve as formulation lead for regulatory interactions, agency questions, and inspections
Build, mentor, and lead a formulation development team
Set technical direction, priorities, and timelines for late-stage formulation deliverables
Manage and provide technical oversight to CDMOs and contract laboratories
Review and approve formulation development protocols, development reports, and regulatory documentation

Requirements

What you’ll need

Experience with monoclonal antibodies, including monotherapy and co-formulation
Experience with PFS/Autoinjector selection studies
Master's degree with 8+ years of relevant experience OR PhD with 6+ years of relevant experience in a scientific discipline
Relevant industry experience in phase-appropriate formulation development and container closure selection studies
Experience with methods including U/HPLC, Capillary Electrophoresis, Spectrophotometry, Bioassay (ELISA and Cell-Based), and device functional testing
Experience with formulation robustness studies supporting PC/PPQ and commercialization
Experience with late-phase comparability studies focused on commercialization
Experience authoring/contributing to regulatory filings, specifically Module 3 for formulation development and stability studies
Track record of successful tech transfers between CDMOs for late-stage development and commercial launch
Excellent writing, organization, communication, and people management skills
Ability to work effectively with diverse internal and external stakeholders
Creative and strategic mindset
Ability to work in a fast-paced environment
Up to 20% travel required

Benefits

Comp & perks

Competitive base salary
Equity
Performance-related bonus opportunity
Competitive salary and benefits package
Supportive and inclusive team environment
Opportunities for professional growth and development
Chance to be part of a vibrant startup culture where work can directly impact bringing new medicines to patients