Principal Scientist/Associate Director
Bioassay Analytical Development
Posted on 11/30/2023
INACTIVE
Chroma Medicine

51-200 employees

Pioneering single-dose genomic medicines using epigenetics
Company Overview
Chroma Medicine is a pioneer in the field of genomic medicine, leveraging the power of epigenetics to develop single-dose treatments that precisely control gene activity without altering the DNA sequence. Their work is based on groundbreaking research from leading genomic medicine experts, giving them a competitive edge in the development of a new class of therapeutics. This focus on precision genomics and commitment to curing diseases makes Chroma Medicine an exciting and rewarding place to work.
Biotechnology
B2B

Company Stage

Series B

Total Funding

$260M

Founded

2021

Headquarters

Boston, Massachusetts

Growth & Insights
Headcount

6 month growth

13%

1 year growth

66%

2 year growth

250%
Locations
Cambridge, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
CategoriesNew
Medical, Clinical & Veterinary
Biology & Biotech
Requirements
  • Advanced degree (MS or PhD) in Biological, Biochemistry, Bioengineering, or related life sciences field with strong scientific background and 8+ years’ relevant experience.
  • Preference for experience in the pharmaceutical or biotechnology industry as part of teams delivering complex biologics to patients.
  • Hands-on experience analyzing DNA/RNAs, oligonucleotides, or proteins by ELISA, qPCR, ddPCR, flow cytometry, western blot, and other techniques. Method development experience on mRNA/gRNA related DS/DPs is highly valued.
  • Knowledge/hands-on experience in CRISPR/Cas9 gene editing technologies and/or lipid nanoparticle delivery a plus.
  • Experience in leading cross-functional collaborations with other departments (e.g., research, process development, quality control) as well as external CDMOs.
  • Knowledge of FDA, EMA and ICH regulations, and understanding of product development life cycle.
Responsibilities
  • Lead a team of scientists and associates to develop and optimize fit-for-purpose bioassays and functional assays for research grade material, including mRNA and gRNA related products.
  • Develop analytical strategy and work plan for the Bioassay Analytical Development (BA) team and provide guidance and mentorship to direct reports.
  • Develop methods intended for a variety of purposes, including release and stability testing, product characterization, high throughput analysis, and functional and potency assays for mRNA/gRNA drug substance characterization.
  • Manage analytical method technical transfer from AD to QC and external CDMOs.
  • Lead assessment and implementation of new technologies and assay platforms.
  • Review, interpret, and present data within the analytical team and cross-functionally.
  • Support QC with required data, technical support (e.g., investigations, specifications, comparability, and assay qualification/validation), and document reviews.
  • Support process development and delivery science for related studies (formulation, stability, etc.), and characterize drug substances and drug products.
  • Support CMC-related regulatory filings for gene therapy programs by authoring and reviewing documents and providing technical expertise on analytical methods and strategies.
  • Author and review test methods, technical reports, and supporting procedures.
Desired Qualifications
  • Knowledge/hands-on experience in CRISPR/Cas9 gene editing technologies and/or lipid nanoparticle delivery
  • Experience in leading cross-functional collaborations with other departments (e.g., research, process development, quality control) as well as external CDMOs
  • Knowledge of FDA, EMA and ICH regulations, and understanding of product development life cycle