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Senior Scientist I, Quality Control

Boston, MA

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-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immunological diseases, among others.

Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45 and 50 skipping amenable. We have also 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 patient focused and excited about the opportunity to bring your expertise in quality control experience to our team. You enjoy a fast-paced environment and juggling competing priorities. You work best not siloed, but as a collaborator across different functional groups, including Discovery, Process Development, Pharmacology, Product Development, and CROs/CDMOs. You bring strong interpersonal skills to effectively build working relationships inside and outside the company. 

The Opportunity

We are seeking a Senior Scientist who is experienced, highly energetic, and committed to the integrity and accuracy of our QC processes. This role will be responsible for the analytical and quality control aspects related to safety, identity, and purity analysis of oligonucleotides, biologics and biologics conjugates. This work will support early and late-stage CMC activities for drug substances and drug products used in the non-clinical and clinical studies. 

Responsibilities

  • Lead and support the development, optimization, and qualification activities for the release, stability, and extended characterization of different modalities, including oligonucleotides, therapeutic enzymes, proteins, and protein conjugates, according to cGMPs.
  • Partner with CDMOs on analytical method transfer, phase-appropriate qualification, reference standard generation and qualification, stability program management and other quality control related activities.
  • Prepare and review QC-related documentation, including standard analytical test methods, reports, protocols, regulatory filings (IND, IMPD, etc.), patent applications, and publications (including review for technical correctness and regulatory compliance).
  • Serve as a subject matter expert on multiple projects, and authors and reviews change control documents, deviations, and investigation reports.
  • Perform data trending to support assay performance and stability data evaluation.
  • Interpret experimental data for conformance with DS/DP/material specifications, perform reference standard qualification and re-qualifications, and carry out deviations and OOS/OOT/OOE investigations and batch disposition.
  • Give technical guidance and training to other laboratory staff as required.
  • Mentor and potentially manage junior level scientists and research associates.
  • Communicate, work closely and provide analytical updates to cross-functional team members.
  • Maintain proficiency in the latest analytical technologies as well as emerging analytical development strategies.
  • Review and evaluate new methodologies /techniques to add to laboratory capabilities.

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 Biochemistry, Analytical Chemistry or a related discipline with a minimum of 4 years or MS and 8+ years of quality control experience in a Biotech or Pharmaceutical industry under GMP environment. 
  • A strong background and in-depth working knowledge of separation sciences, including but not limited to: HPLC (RP, HIC, HILIC, IEX and SEC) and CE (CE-SDS, cIEF). LC-MS and LC-MS/MS experience is a plus.
  • Quality control experience for GMP manufacturing, including but not limited to routine and non-routine testing within a GMP environment, data trending, analytical method transfer, phase-appropriate method qualification/validation, DS and DP specification setting, and in-process/release/stability testing. 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.

The Perks

By becoming a team member here at Entrada, you’ll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.

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