The Perfect Addition to Our Team

You are motivated, resourceful, and enthusiastic quality control lead excited to be a key contributor for the company at a critical stage in its growth trajectory. You will support CDMO to oversight the AD&QC aspect of process performance qualification campaign and ensure all activities are completed according to established timelines and quality standards, and applicable regulatory guidelines. You will support the life cycle management of the analytical methods and region-specific specifications at the commercial stage. You will work with CMC technical SMEs, QA and Regulatory to ensure regulatory submission readiness, including but not limited to authoring and reviewing AD&QC related sections of IND, IMPD, NDA, MAA and global regulatory submissions and providing support in addressing information requests. You will also support CDMO on GMP commercial manufacturing readiness.

At Entrada, you will not be siloed, but rather expected to interact across different functional groups, including, non-clinical development, quality Assurance, Regulatory, and CRO/CDMOs. Your ability and desire to thrive in a nimble, fast-paced results-driven environment will set you up for success.
The Opportunity

In this position you will lead late-stage AD&QC activities both internally and externally related to safety, identity, and purity of oligonucleotides programs. This work will support late-stage to commercial CMC activities for drug substances and drug products used in late-phase clinical studies and ensure NDA regulatory submission readiness. Finally, we hope you enjoy communicating your processes and findings across different formats including authoring and reviewing regulatory filings (IND, IMPD, NDA, MAA etc.), patent applications, publications (including review for technical correctness and regulatory compliance) and in internal and external meetings because your work will be critical to the success of the entire company and our ability to treat devastating diseases.
Responsibilities

• 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, representing AD&QC functions and ensuring inspection readiness.
• 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 to enhance quality, regulatory compliance, operational efficiency, and inspection preparedness.
The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

• Humanity - We genuinely care about patients and about one another.
• Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
• Creativity - We are creative problem solvers.
• Collaboration - We are more than the sum of our parts.
• Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

• A Ph. D in Organic Chemistry, Analytical Chemistry or a related discipline with a minimum of 6 years of late-stage and commercial AD&QC experience in a Biotech or Pharmaceutical industry.
• Strong knowledge of the requirements for the AD&QC aspect of late-stage and commercial oligo programs, especially PMO and PPMO, is highly desired.
• Extensive experience in regulatory filing, including IND, IMPD, NDA and MAA.
• Strong knowledge and hands-on experience in regulatory requirements and guidelines (ICH/FDA/EMA/USP/Ph. Eur.) with respect to quality control for oligonucleotides drug product late-stage manufacturing, PMO and PPMO experience is a strong plus.
• Extensive knowledge of cGMP regulations and guidelines.
• Experience contributing to product quality risk assessments to identify critical quality attributes and developing associated limits/specifications.
• Excellent communication (written and verbal) and interpersonal skills.
• Strong attention to detail and results driven in line with project and team objectives
• Ability to handle multiple high-priority tasks in parallel to meet organizational goals
• Experience contributing to product quality risk assessments to identify critical quality attributes and developing associated limits/specifications.

This is a US based remote position, with preference given to local New England based candidates who can be in office 1 day per week. This role will require a minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA.
What We Offer: Meaningful Work, Fair Rewards, and Real Support

At Entrada Therapeutics, we understand that compensation and total rewards are a major consideration when exploring a new opportunity. We believe in transparency and equity and are committed to sharing salary ranges for every position, along with insight into our compensation philosophy, in accordance with certain state requirements in the United States and fostering a fair and open environment at the onset.

But we also know it is more than just pay. When you join Entrada, you'll be part of a mission-driven team with access to comprehensive health, dental and vision coverage; life and disability insurance; with a 401(k) match. We pride ourselves on offering competitive benefits that empower our employees and reflect the value of their contributions - offering paid, gender-inclusive parental leave, holistic support for your health and well-being, education reimbursement, discretionary time off and commuting benefits aligned to your working model. If you find yourself working from our office in Boston's Seaport District, this puts you steps away from some of the best the city has to offer.

The salary for this opportunity ranges from $172,000 - $202,000. The final base compensation offered will depend on several considerations which include but may not be limited to a candidate's skills, competencies, experience and other job-related factors permitted by law. The final salary offered may fall outside of this range. #LI-JF1 #LI-Remote