ADME Scientist
Dicerna Pharmaceuticals, Inc.
 Lexington, MA

We are seeking an ADME Scientist to help advance the development of our growing pipeline of product candidates. The individual in this position will be responsible in the oversight of anti-drug antibody (ADA) projects conducted at external contract research organizations (CRO) as well as internal assay development. As a member of the ADME team, the individual will also participate in other ADME-related studies.

Key Responsibilities

  • Responsible for management and operational oversight of ADA studies conducted at CROs including design of immunogens for the generation of positive-control antibodies, assay method development and validation, and sample analysis
  • Ensure methods and validation studies are designed and executed in compliance with appropriate regulatory guidance, internal SOPs, and industrial best practices
  • Work closely with CROs to ensure that all studies are performed under appropriate quality standards and deliverables meet program timelines
  • Facilitate study-related shipments and data transfer
  • May participate in CRO evaluation, qualification, and on-site monitoring
  • Develop in-house ADA assay methodology and contribute to design of immunogen constructs for new immunization projects
  • May contribute to the preparation of nonclinical components for regulatory submissions
  • Collaborate cross functionally with Research, Regulatory, Clinical, and relevant program teams
  • Communicate ADA timelines and data to stakeholders as needed
  • Some travel may be required depending on program needs

Qualifications

  • PhD or M.S (2+ yrs experience) or B.S. (8+ yrs experience) in a scientific discipline, bioanalytical or ADME-related discipline preferred
  • Experience with ADA assay development, validation, and associated data analysis
  • Previous industry experience is highly preferred
  • Experience with oligonucleotides preferred but not required
  • Experience performing molecular and cellular biology techniques, including but not limited to ELISA, ADA assay development, PCR, and bioanalytical techniques
  • Knowledge of GLP and GCP standards as well as immunogenicity guidances (FDA, EMA)
  • Attention to detail and ability to critically evaluate all study documentation (e.g. protocols, data, reports)
  • Effective organization skills and ability to work in a multi-tasking, fast-paced environment
  • Ability to work well in a team setting/matrix-type organization and to build strong cross-functional relationships
  • Enthusiasm for meeting program timelines and goals