Senior Scientist II, Drug Substance Manufacturing & Development

The Organization

What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. 

Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA- and protein-based programs for the potential treatment of neuromuscular and ocular diseases, among others.

Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.

We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.

The Perfect Addition to Our Team

You are a motivated, resourceful, and enthusiastic Peptide and Oligonucleotide Manufacturing expert excited to support the company at a critical stage in its growth trajectory. You enjoy a fast-paced environment and juggling competing priorities and are willing to jump in and help wherever it is needed. You follow up and follow through, efficiently connecting technical problems with operational solutions. You work successfully in a team environment and have strong interpersonal skills, to effectively build working relationships inside and outside of the company.

The Opportunity

The Senior Scientist II will support and lead late-stage drug substance development and manufacturing for Entrada’s novel pipeline programs. Reporting into the Senior Director, Drug Substance & Manufacturing, this individual will provide oversight for non-GMP and GMP Drug Substance manufacturing (for pre-IND through late-phase clinical studies) remotely and performing activities with minimal supervision in a collaborative matrix setting.

At Entrada, you will not be siloed, but rather expected to interact across different functional groups, including Chemistry, Analytical Development, Drug Product Development, Pharmacology, Product Development, Quality, and external CDMO partners. This individual’s ability and desire to thrive in a nimble, fast-paced results-driven environment will set them up for success.

Responsibilities

• Provide technical support on process development for intermediates (peptide and oligonucleotide) and drug substance at CDMOs applicable for late-stage programs.
• Identify and resolve manufacturing/testing issues and escalate appropriately to internal and/or joint governance if required.
• Review Master Batch Records, Executed Batch Records, and other cGMP documentation to enable release and disposition of materials.
• Partner closely with other internal functions including Chemistry, Quality Control, Quality Assurance, DP formulation development, and Regulatory Affairs to ensure programs are effectively supported while maintaining high-quality standard.
• Conduct process risk assessment using FMEA or DoE for Oligos/Peptides/DSs.
• Develop, author, and review protocols, reports, investigations, deviations, and documentation related to manufacturing, including quality documents.
• Author and/or review change controls to introduce process improvements through the lifecycle of programs from Phase 1 through Phase 3/validation and commercialization.
• Author and/or review related sections in regulatory filing documents (IND, IMPD, NDA, BLA, MAA, etc.) and support health authority questions as needed.
• Partner with Entrada team for CDMO due diligence during new CDMO selection to vet capabilities, risks and investments as required.
• Manage material logistics and inventory (internally and externally).

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: