Associate Director, Technical Operations – Biologics Drug Substance Manufacturing

Travere Therapeutics

Associate Director of Technical Operations managing biologics drug substance manufacturing. Collaborating with teams on processes, quality, and regulatory compliance at Travere Therapeutics.

Posted 7/17/2026full-timeSan Diego • California • 🇺🇸 United StatesSenior💰 $150,000 - $195,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates strong technical expertise in biologics manufacturing, including microbial fermentation and downstream processing, while ensuring compliance with cGMP regulations and effective lifecycle management. Proficient in technical writing and documentation, supporting regulatory submissions and process validation activities.

Highest-signal resume keywords

Biologics ManufacturingMicrobial FermentationDownstream ProcessingTechnical WritingCGMP Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process ValidationTech TransferProcess CharacterizationStatistical Process MonitoringQuality Risk ManagementChange ControlDeviation ManagementCAPARegulatory SubmissionsProcess Optimization

Soft Skills

Interpersonal SkillsOrganizational SkillsCommunication Skills

Industry Keywords

INDBLACGMPFDAICHLifecycle ManagementProcess Scale-UpClinical DevelopmentManufacturing EfficiencyPEGylation

About the role

Key responsibilities & impact

Provide technical oversight for drug substance manufacturing activities supporting late-stage clinical and commercial biologics programs at Travere’s CDMOs
Review and approve manufacturing related documents including change notifications, batch records, process development, tech transfer, process characterization (PC) and PPQ protocols and reports
Serve as technical resource for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections
Monitor process performance data, identify process trends, and recommend improvements to increase process robustness, product quality, and manufacturing efficiency
Support tech transfer and process scale-up at CDMOs
Partner with Regulatory Affairs to prepare technical documentation supporting CMC sections of IND, BLA, and regulatory agency responses
Author technical reports on a variety of manufacturing related subjects
Support lifecycle management activities, including process optimization, post-approval changes, and continued process verification (CPV)

Requirements

What you’ll need

Bachelor’s degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related discipline required
8+ years of relevant experience including biologics manufacturing, scale-up, and late stage drug development and commercialization
Strong technical expertise in microbial fermentation and downstream processing for recombinant proteins or other biologic products
Experience in PEGylation is a plus
Demonstrated experience supporting late-stage clinical development through commercial manufacturing
Direct experience with QbD and supporting PPQ and process validation activities
Broad knowledge of US and EU cGMP regulations, FDA and ICH guidance, technology transfer, process validation, and lifecycle management
Experience working with external CDMOs, including oversight of manufacturing campaigns and technical issue resolution
Working knowledge of statistical process monitoring, process characterization, and quality risk management tools
Experience interpreting manufacturing data, troubleshooting process issues, and implementing scientifically sound solutions
Excellent technical writing and documentation skills, including preparation of protocols, reports, investigations, and regulatory documentation
Strong interpersonal and organizational skills and exceptional communication skills are required
Ability to travel 20%-25% domestically and internationally

Benefits

Comp & perks

premium health, financial, work-life and well-being offerings for eligible employees and dependents
wellness and employee support programs
life insurance
disability
retirement plans with employer match
generous paid time off