Partner with internal cross-functional teams and external CDMOs to provide AD&QC support for late-stage activities, Process Performance Qualification (PPQ) campaigns, and commercial manufacturing.
Develop and implement comprehensive AD&QC strategies to support successful regulatory submissions and ensure commercial readiness.
Lead analytical method lifecycle management activities, including method transfer, validation, verification, comparability assessments, and ongoing method performance monitoring.
Establish, scientifically justify, and maintain analytical specifications and sampling plans throughout the product lifecycle.
Author, review, and approve AD&QC-related sections of regulatory submissions, including INDs, IMPDs, NDAs, MAAs, and post-approval supplements.
Provide AD&QC expertise in support of health authority inspections and responses, ensuring all AD&QC documentation remains compliant with current ICH, FDA, EMA, and other applicable global regulatory requirements.
Serve as the AD&QC Subject Matter Expert during regulatory inspections, partner audits, and quality system assessments.
Collaborate closely with DS/DP Development & Manufacturing, Quality Assurance, and Regulatory Affairs to support product development, technology transfer, commercialization, and lifecycle management activities.
Establish and monitor key AD&QC performance metrics and drive continuous improvement initiatives.
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About Entrada Therapeutics
Entrada Therapeutics pioneers a new class of medicines, called EEV™ therapeutics, to deliver life-changing treatments for devastating diseases. You will find us advancing a robust portfolio of genetic medicines, particularly for Duchenne muscular dystrophy (DMD) and Myotonic Dystrophy Type 1 (DM1). Our innovative Endosomal Escape Vehicle (EEV™) platform efficiently delivers proteins, peptides, and nucleic acids into cells. This proprietary approach targets previously inaccessible intracellular targets, fundamentally transforming patient care. We are bringing these therapies to patients with high unmet medical needs. Entrada went public in 2021, raising $181.5 million, and has secured over $300 million in total funding.
How We Work
You will join a tight-knit team of experts dedicated to therapeutic development and rare diseases. We seek high-energy, dedicated colleagues ready to improve patients' lives. Our core values humanity, tenacity, creativity, collaboration, and curiosity drive our daily actions. We foster a mission-driven culture that celebrates successes and tackles challenges together. Our
Benefits & Perks
Comprehensive health, dental, and vision coverage
Life and disability insurance with a 401(k) match
Paid, gender-inclusive parental leave
Holistic health and well-being support and a $500 wellness account
Education reimbursement for your continued growth
Discretionary time off and commuting benefits
Health Savings Account and Dependent Care Flexible Spending Account
Equity and Employee Stock Purchase Plan
Mobile reimbursement, pet insurance, and financial coaching
Free drinks, snacks, company lunches, and birthday treats