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Director, mRNA Process Development

Chroma Medicine

Chroma Medicine

Boston, MA, USA
Posted on Wednesday, October 12, 2022

Chroma Medicine is pioneering a new class of genomic medicines that harness epigenetics, nature’s innate mechanism for gene regulation, revolutionizing the treatment of genetically driven diseases. As a start-up genomic medicine company with world-leading scientific founders, strong investment backing including Newpath Partners and Atlas Venture, and experienced leadership, Chroma is positioned to be the leader in epigenetic editing.

The epigenome is nature’s gatekeeper for gene expression, governing cell phenotype and function by precisely controlling gene activity without changing the underlying DNA sequence. Building on groundbreaking research from the world’s foremost genomic medicine experts, Chroma Medicine is working at the cutting edge of precision genomics, building an entirely new class of therapeutics to achieve unparalleled control of gene expression.

We are hiring at our Boston, Massachusetts site, offering a unique opportunity to be part of our foundational Chroma team.

ABOUT THE ROLE

You will be responsible for developing and optimizing each segment of Chroma’s gram-scale mRNA production process. Reporting to Sr. Dir. of Process Development & Delivery (PD&D), the ideal candidate will have leadership to build a team and collaborate with external vendors to develop commercial-scale mRNA synthesis and purification systems.

RESPONSIBILITIES

  • Develop Chroma’s mRNA Process Development strategy, identify the process-related risks, build in-house process knowledge of design space, and improve/maintain high quality mRNA to support our leading programs.
  • Utilize both internal team and external resources (ie CDMO, CRO, vendors) to develop, optimize and implement Chroma’s research grade, gram-scale mRNA process and production for material supply; including plasmid production and IVT template linearization processes.
  • Manage budgeting & strategic planning &staffing for mRNA Process Development.
  • Contribute as CMC mRNA PD representative for future GMP production support & lead regulatory filing sections as needed.
  • Collaborate with Analytical Development and Quality Control to develop Chroma’s mRNA process-related quality specifications.
  • In collaboration with Chroma’s R&D group, develop and implement improvements to Chroma’s high-throughput mRNA production process.

SKILLS & COMPETENCIES

  • Leadership to build & develop a team, collaboration cross functionally and manage external vendors.
  • 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.
  • Ability to thrive in a fast-paced, innovative, and, at times, uncertain or changing 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

  • MS in a relevant discipline with 10+ years of experience in process development or PhD with 5+ years of experience.
  • Experience with mRNA process development is required, preferably with hands-on downstream purification.
  • Proven experience developing a GMP ready mRNA process with systematic approach and planning/analytical tools is desired.
  • Extensive understanding of cGMP compliant process requirements, and previous tech transfer experience, including IND filing is a strong plus.
  • Experience supporting development programs, including communicating between function and CMC and/or Program Team.
  • Familiarity with mRNA biology and the biological impact of mRNA modifications is a strong plus.
  • Preference for candidates with experience in the pharmaceutical or biotechnology industry

Chroma Medicine is an equal opportunity employer, providing equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, Chroma Medicine complies with applicable state and local laws governing nondiscrimination in employment.

COVID-19 Vaccination Policy: All Chroma Medicine team members must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemptions for medical or sincerely held religious beliefs will be considered.