Senior Manager, Protein Sciences – Downstream

Iovance Biotherapeutics, Inc.

. Serve as subject matter expert in protein purification, drug product formulation, fill, and lyophilization .

Posted 9/15/2026full-timeUnited StatesSenior💰 $165,000 - $180,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in protein purification, drug product formulation, and GMP manufacturing processes, with a strong focus on operational excellence and regulatory compliance. Proven ability to manage cross-functional teams and drive technical improvements in biotherapeutics manufacturing.

Highest-signal resume keywords

Protein PurificationGMP ManufacturingBiotherapeutics ManufacturingRegulatory ComplianceOperational Excellence

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Protein CharacterizationDrug Product FormulationLyophilizationProcess DevelopmentTechnical TransferValidationCOGS ImprovementRisk AssessmentMicrobial Control StrategiesAnalytical Strategy Development

Soft Skills

Strong Verbal CommunicationStrong Written CommunicationProblem-SolvingJudgmentClear Thinking

Industry Keywords

Contract Manufacturing OrganizationsQuality ControlSupply ChainRegulatory FunctionsGlobal Business Environment

About the role

Key responsibilities & impact

Serve as subject matter expert in protein purification, drug product formulation, fill, and lyophilization
Manage Iovance GMP manufacturing and contracted manufacturing operations for protein production and characterization, focusing on downstream processes
Plan, coordinate, and oversee contract manufacturing and development services through the product life cycle
Oversee process development, transfer, scale-up, validation, COGS improvements, and technical change/improvement studies
Collaborate with Process Development, Analytical Development, Manufacturing, Quality Control, Quality, Supply Chain, and Regulatory functions
Lead or support CMC product teams and subteams, manage technical information/data flows, milestones, audits, qualification, validation, and regulatory filing activities
Manage manufacturing data for selected clinical/commercial products
Support knowledge management, process and analytical strategy development, microbial control strategies, risk assessment, and mitigation
Build relationships with key Contract Manufacturing Organizations
Manage technical transfer and technical/COGS improvement projects, stakeholder engagement, and on-time/in-budget delivery
Support regulatory CMC and registrational activities, especially ex-US
Liaise with Quality and Supply Chain on product disposition and systems alignment; support investigations, deviations, CAPAs, and site audits
Support hiring and staff development
Ensure CMO operational readiness for campaigns, transfers, change controls, and validations
Apply operational excellence and lean principles to develop efficient, robust systems

Requirements

What you’ll need

Minimum of 9 years of related experience with a Bachelor's degree; or 7 years and a Master's degree; or a PhD with 4 years of experience in a relevant Life Science discipline or equivalent in work experience
In-depth understanding of protein purification, characterization, drug product formulation, fill, and lyophilization
Strong prior operational experience, preferably in a direct role in a GMP manufacturing environment, with interfaces to Supply Chain, Quality, and Regulatory functions
Thorough understanding of biotherapeutics manufacturing
Experience working in a global business environment across multiple time zones
Strong verbal and written communication skills
Ability/willingness to travel globally for extended periods based on business needs
Ability to remain standing or sitting for prolonged periods
Ability to work on a tablet or computer for 80% of a typical working day
Ability to move and lift 15 pounds
Wear proper personal protective equipment in warehouse/laboratory settings
Clear and conceptual thinking, judgment, troubleshooting, problem-solving, analysis, and discretion
Ability to handle work-related stress, multiple priorities, and deadlines

Benefits

Comp & perks

Reasonable accommodations may be made upon request
Equal-opportunity employer
Assistance or accommodation to apply available upon request