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Senior Scientist, Bioanalytical

Employer
Entrada Therapeutics
Location
Boston, MA
Start date
Sep 21, 2023

View more

Discipline
Science/R&D, Biotechnology
Required Education
Associate Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Job Details

The Organization

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. 

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. You will be responsible for mentoring members of the team and be accountable for their day-to-day operations and development. You will successfully lead and coordinate bioanalytical support functions across various modalities, including oligonucleotide and biologics modalities, to perform quantitative bioanalysis in complex biological matrices, and to actively explore, investigate and implement innovative technologies to facilitate program progress. You will lead internal efforts as well as managing external activities at CROs to provide timely bioanalytical support for pre-IND and IND enabling 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 methods supporting PK and biodistribution using LC-MS/MS and ligand binding assays to support EEV-conjugated therapeutics including oligonucleotides, biologics, and peptides.
  • Perform hands-on method development and sample analysis support and manage a team of scientists to supporting non-GLP studies (PK) in various biological matrices (plasma, CSF, urine, and tissues, etc.). Create high-quality data and reports in a timely manner to meet timeline deliverables.
  • Oversee non-GLP and GLP bioanalytical activities at CRO partners; provide scientific guidance and technical support on method transfer/development, qualification/validation, and sample analysis at CROs.
  • Evaluate and implement new and upcoming technologies/platforms outside field of expertise to meet challenging program needs.
  • Mentor and train scientists/associates on scientific concepts and technical details of various bioanalytical approaches, as well as regulatory requirements in a GLP/GxP environment.
  • Implement processes to ensure both internal and external timelines are met with data integrity and good documentation practice, communicate and interface with stakeholders including discovery, preclinical, CMC, and clinical team and external CROs to define and deliver strategies to support project timelines across multiple programs.
  • Write and review protocols and bioanalytical sections to be included in regulatory filings; act as a SME in the Bioanalytical group for GLP/GxP regulations and health authority guidances.
The Necessities

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:

  • PhD in chemistry, biochemistry, pharmacology, analytical chemistry, or a related field with 4-6 years of post-doctoral experience; or a master’s degree with 8+ years of experience.
  • Demonstrated leadership and project management/organizational skills. Experience with managing direct reports is required.
  • Subject matter expert with extensive hands-on experience developing, qualifying, and validating LC-MS/MS-based bioanalytical assays to support a variety of modalities including oligonucelotides, biologics, and peptides.
  • In-depth knowledge and strong experience with assay development, transfer, qualification, and validation to external CROs in a GLP/GxP environment.
  • Ability to work independently in a fast-paced environment, as well as in a cross-collaborative team setting. Excellent communication skills (oral and written) and a track record of cross-disciplinary collaboration.
  • 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.
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.

 

Company

Entrada Therapeutics is a biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines, Endosomal Escape Vehicle (EEV™) therapeutics, to engage intracellular targets that have long been considered inaccessible and undruggable. The Company’s EEV therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues with an improved therapeutic index. Through its proprietary, highly versatile and modular EEV platform, Entrada is building a robust development portfolio of oligonucleotide-, antibody- and enzyme-based programs for the potential treatment of neuromuscular diseases, immunology, oncology and diseases of the central nervous system. The Company’s lead oligonucleotide programs include ENTR-601-44 targeting Duchenne muscular dystrophy (DMD) and ENTR-701 targeting myotonic dystrophy type 1 (DM1).

Stock Symbol: TRDA
Stock Exchange: NASDAQ

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Company info
Website
Telephone
+1-857-520-9158
Location
One Design Center Place Suite 17- 500
Boston
Massachusetts
02210
United States

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