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Associate Director Bioanalytical Development

Carbon Biosciences

Carbon Biosciences

Waltham, MA, USA
Posted on Wednesday, September 6, 2023

About Us:

Carbon Biosciences is a team of passionate drug developers extending the reach of genetic medicines for the treatment of devastating diseases. We combine the genetic diversity and potency of viruses that have evolved over millions of years with the recent clinical and manufacturing advances in the gene therapy field. Our proprietary CBN vector library has the potential advantages of exquisite tissue specificity, larger payloads and durable treatment strategies across multiple modalities. Our goal: realize the power of natural viral evolution and deliver on the promise of genetic medicines.

Our goal: realize the power of natural viral evolution and deliver on the promise of genetic medicines.

About you

As the Associate Director*, Bioanalytical Development you will be the primary subject matter expert to explore the pharmacokinetic and biodistribution profile of novel viral capsids. This role requires an innovative approach to support the broad screening efforts of our Platform Team to interrogate and prioritize vectors, identify relevant species, and develop study designs to support development teams, often exploring novel disease targets and tissues not typically targeted by gene therapies.

*(commensurate with experience)

Responsibilities:

  • Represent Bioanalytical Development on Research and Development teams, initially as an individual contributor, but building a scalable organization to support our expanding portfolio.
  • Possess a working knowledge of applicable regulatory guidelines to understand testing requirements and industry best practices for establishing gene therapy exposure & tropism.
  • Prepare study proposals, protocols, reports, and regulatory documents necessary to support the nonclinical development of drug candidates.
  • Collaborate & cross-functionally support other disciplines (Clinical, Regulatory, Toxicology, CMC, & Research).
  • Ensure appropriate project management and oversight for work conducted at CROs, including assay development or transfer, qualification, and biomarker identification.
  • Support business development activities as a subject matter expert.
  • Work closely with clinical development to support a seamless transition from nonclinical assays to a clinical trial setting.

Preferred qualifications

  • Ph.D. with minimum of 6 years or Master’s degree with minimum 10 years in a relevant discipline with experience in developing and conducting bioanalytical studies, assay development/ qualification/validation, and viral shedding assays to support nonclinical and ideally clinical gene therapy programs.
  • Demonstrated expertise in bioanalytical assay platforms including ELISA, MSD, MS, and, qPCR/ddPCR.
  • Experience and understanding of FDA, EMA, and ICH regulatory guidance in bioanalytical assay development, validation, and GLP study conduct.
  • Hands-on experience with developing and troubleshooting pharmacokinetics and biomarker assay development.
  • Establish and maintain visibility as an industry expert in gene therapy bioanalytical development, influencing current industry best practices and regulatory perspectives through consortia participation, publishing, and external presentations.
  • viral vector gene therapy experience highly desirable

Our Values

At Carbon, we believe open and honest communication is the foundation of a culture that drives success. By speaking and truly listening as a team, we nurture innovation by collaborating and recognizing each other’s strengths. Our teammates challenge assumptions and accept ownership and accountability, demonstrating industry-leading initiative in the pursuit of our goal to deliver on the promise of genetic medicines.

MESSAGE TO RECRUITERS: While Carbon respects the work you do, we would appreciate you not reaching out to our hiring managers as they have no time to field your inquiries and will only forward them to our TA staff.

POSITION: Full-Time, Exempt

EEOC Statement: Carbon Biosciences is proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, sage, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability or any other status protected under federal, state or local law. All employment is decided on the basis of qualifications, merit and business need.