ABOUT THE ROLE

Chroma is seeking a Principal Scientist/Associate Director to lead its Bioassays team in Analytical Development designing, developing, and qualifying various phase appropriate bioassays to support Chroma’s growing gene therapy pipeline.

• This individual will be leading a cross-disciplinary team to identify, evaluate, and implement new biological assays to evaluate the therapeutic functions of LNP-encapsulated mRNA and/or gRNA drug product and drug substances.
• The position will be part of an integrated R&D team that aims to advance preclinical gene therapy candidates into the clinic and work closely with research, delivery science, process development, technical operations, and quality control teams.

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.

SKILLS & COMPETENCIES

• Impactful leadership skills and demonstrated ability to build and lead a new team
• Excellent analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective
• Strong oral and written communication skills with experience presenting scientific research both internally across all levels of the organization and externally to other interested parties
• Ability to thrive in a fast-paced, innovative, and dynamic environment while remaining flexible, proactive, and resourceful
• Adept at prioritizing and managing multiple tasks simultaneously, integrating cross-functional issues, and balancing competing priorities effectively
• Collaborative and team-oriented mindset with a desire to positively impact a new company’s evolving culture
• Passionate, adaptable, and keen on working in the fast-paced biotech startup space to drive cutting-edge science

QUALIFICATIONS:

• 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.