Associate Director, CMC

What's happening at Entrada Therapeutics? Our mission is to transform the treatment of devastating diseases by establishing a new class of medicines to engage intracellular targets that have long been considered inaccessible and undruggable.

Our Endosomal Escape Vehicle (EEV™)-therapeutics represent a fundamental advancement in the field of intracellular therapeutics. They 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 our EEV platform, we are building a diverse pipeline of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, immunological, ocular and metabolic diseases, among others. 

Our lead oligonucleotide programs include ENTR-601-44 and ENTR-601-45 for the potential treatment of people living with Duchenne who are exon 44 and 45 skipping amenable, respectively, as well as our partnered candidate ENTR-701 targeting myotonic dystrophy type 1 (DM1). 

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. 

You are a motivated, resourceful, and enthusiastic oligonucleotide/oligonucleotide-peptide conjugate focused analytical development and quality control lead excited to be a key contributor for the company at a critical stage in its growth trajectory. You will lead all the CMC analytical method transfer, phase-appropriate qualification, reference standard generation and qualification, stability program management and other quality control related activities for the oligonucleotide projects, including but not limited to in-process/release/stability testing and batch disposition of drug substance intermediates, drug substance, and drug product. You will prepare/ review analytical method transfer protocols, method evaluation reports and other technical documents for quality and regulatory compliance. Other responsibilities include but are not limited to: 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.

At Entrada, you will not be siloed, but rather expected to interact across different functional groups, including Discovery, Process Development, Pharmacology, Product Development, and CRO/CDMOs. Your ability and desire to thrive in a nimble, fast-paced results-driven environment will set you up for success.

• In this position you will own the analytical and quality control aspects related to safety, identity, and purity analysis of oligonucleotides and oligonucleotide-peptide conjugates. This work will support early and late-stage CMC activities for oligonucleotide drug substance and drug product used in the non-clinical and clinical studies. Ideally, you will be able to lead these analytical method transfer, optimization, and qualification activities independently with minimal supervision. You will maintain batch-related data and trends for specification-setting purposes. You will serve as a subject matter expert on multiple projects, and authors and reviews change control documents, deviations, and investigation reports. Finally, we hope you enjoy communicating your processes and findings across different formats including authoring and reviewing standard test methods, reports, protocols, regulatory filings (IND, IMPD, 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. 

• Plan and execute analytical method development, optimization, and qualification experiments including identity, purity, and safety analysis of a variety of different therapeutic modalities.
• Bring an innovative and efficient mindset to our chromatography and mass spectroscopy methods and techniques.
• Contribute to SOPs, reports, protocols, and regulatory documents, patent applications, and publications.
• Mentor Research Associates and students from across the company.
• Maintain laboratory equipment including calibration and standard maintenance activities.
• Present data and research findings at team meetings, review meetings, and external conferences and be acknowledged and appreciated for your contributions, effort, and passion.
• Thrive in a collaborative environment.

At Entrada, our passion for science, our devotion to patients and our values drive 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, Biochemistry, Analytical Chemistry or a related discipline with a minimum 6 years (or 10 years with a MS. Degree) of relevant Antisense Oligonucleotide (ASO) analytical method development in a Biotech or Pharmaceutical industry under GMP environment.
• A strong background and in-depth working knowledge of oligonucleotides and oligo-peptide conjugates analysis, including but not limited to: Assay and Purity (RP-HPLC, IP-RP-HPLC, AEX/CEX-HPLC), identity (LC-MS high resolution intact mass), Sequencing (LC-MS/MS) techniques, is essential. PMO and PPMO experience will be considered as a strong plus.
• Quality control experience for the oligonucleotide GMP manufacturing is highly valued, including but not limited to analytical method transfer, phase-appropriate method qualification/validation, DS and DP specification setting, in-process/release/stability testing, and batch disposition.
• Excellent communication (written and verbal) and interpersonal skills.
• Works independently with minimal supervision and is highly collaborative with other groups
• 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

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.

Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.