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Senior Scientist II, Bioanalytical

4 months ago

Boston, United States Entrada Therapeutics Full time
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

As a member of the Bioanalytical group in the Product Development Team, you are versatile, self-motivated, timeline- and process-oriented, and look forward to rolling up your sleeves and diving into details, and overcoming obstacles. You will be responsible for mentoring members of the team and be accountable for their day-to-day operations and personal career development. You will successfully lead and coordinate bioanalytical support functions across various modalities, including oligonucleotide and biologics modalities, to perform both qualitative and quantitative bioanalysis in complex biological matrices. To accomplish these aims you will actively explore, investigate, and implement innovative technologies to meet program timelines. You will lead internal efforts to provide timely bioanalytical support for discovery projects and pre-IND clinical candidate studies. Additionally, you will be a key contributor to documents supporting regulatory filings and will have the opportunity to contribute to scientific publications.

You also enjoy a fast-paced environment and juggling competing priorities. You have excellent verbal and written communication skills, you follow up and follow through, bringing solutions to problems efficiently. You work successfully in a team environment with strong interpersonal skills to effectively build working relationships inside and outside the company. The Opportunity

Work within the Bioanalytical Team to enable the full spectrum of EEV-conjugated modalities development from early discovery candidate selection through late-stage process development. Responsibilities

  • Develop, qualify, and implement bioanalytical assays using LC-MS/MS and ligand binding assay (LBA) to support PK and biodistribution studies for therapeutic candidates including oligonucleotides, biologics, and peptides.
  • Perform both qualitative and quantitative bioanalysis in various biological matrices (plasma, CSF, urine, and tissues, etc.) across different species. Generate high-quality data and reports in a timely manner to meet project deliverables.
  • Oversee bioanalytical deliverables supporting discovery project activities, candidate enabling studies, and clinical candidate IND enabling studies; provide scientific guidance and technical support on method development, qualification, and sample analysis in-house as well as at CROs.
  • Support the implementation of new and upcoming technologies/platforms both within and outside the field of expertise to meet challenging program needs.
  • Mentor and train team members and colleagues on scientific concepts and technical details regarding various bioanalytical approaches.
  • Lead troubleshooting efforts for bioanalytical assays; Proactively identify and solve technical challenges/bottlenecks to maintain/improve assay robustness and efficiency.
  • Implement processes to ensure timelines are met with data integrity; communicate and interface with stakeholders including discovery, preclinical, CMC, and external CROs to define and deliver strategies in a flexible manner to support project timelines across multiple programs.
  • Interpret and present bioanalytical data internally as well as in cross-functional team meetings; serve as an SME on behalf of the bioanalytical team for technical, strategic, and prioritization discussions to advance program objectives. 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 PhD in chemistry, biochemistry, pharmacology, analytical chemistry, or a related field with at least 5 years of bioanalytical sciences; and an equivalent combination of education and experience (e.g. MS degree with at least 8 years experience) will be considered.
  • Demonstrated leadership acumen and strong project management/organizational skills; Proven track record of fostering a collaborative work environment.
Subject matter expert with extensive hands-on experience with developing, qualifying, implementing, and troubleshooting LC-MS/MS and ligand binding-based assays to support a variety of therapeutic modalities including oligonucleotides, biologics, and peptides. Ability to work independently in a fast-paced, competing priority environment, as well as in a cross-collaborative team setting. Excellent communication skills (oral and written) and a track record of cross-disciplinary collaboration are essential. Knowledge/experience of pharmacokinetics, drug metabolism, immunogenicity, and biomarker studies are highly desirable. Experience with ligand binding assays such as ELISA and MSD is preferred. Knowledge and experience with assay development, transfer, qualification, and validation to external CROs in a GLP/GxP environment is considered a plus. 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. Third Party Staffing Agencies

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. Privacy Statement

Entrada Therapeutics, Inc. (the “Entrada,” “we,” “us,” or “our”) respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information. Please reference our privacy statement here to understand how and when your data is being used.