ABOUT THE ROLE

The Analytical Development team is seeking a motivated and detail-oriented Research Associate to support advancement of the company’s LNP platform and ongoing clinical programs. The successful candidate will work closely with senior team members to support LNP process development, execute analytical testing for in vivo studies, and contribute to the characterization of LNPs as well as mRNA and gRNA payloads.

RESPONSIBILITIES

• Contribute to development of suitable biochemical and biophysical tools for characterizing LNPs containing RNA payloads used in epigenetic editing applications 

• Optimize and troubleshoot existing analytical methods to improve accuracy, reliability, and sensitivity

• Collaborate with research and process development groups to routinely characterize products and process intermediates 

• Contribute to design of experiments, analyze data, and document laboratory work in electronic lab notebooks 

• Contribute ideas and present scientific findings at team meetings 

• Assist with troubleshooting and regular maintenance of critical laboratory equipment and ordering of reagents and consumables

SKILLS & COMPETENCIES:

• Hands-on experience with biophysical characterization of lipid nanoparticle formulations (e.g., SEC-MALS, AF4-MALS, DSC, cIEF, NTA, DLS, SAXS) and/or analysis and characterization of therapeutic nucleic acids (mRNA, oligonucleotides, plasmids) by chromatography (e.g., IPRP/IEX HPLC) and electrophoresis (e.g., CGE) required
• Experience with molecular and immunoassays (e.g., PCR, ELISA) is a plus
• Experience troubleshooting and optimizing routine analytical methods and experimental workflows, including instrumentation
• Working knowledge of data analysis and basic statistical approaches (e.g., quantification, trending)
• Strong organizational skills and attention to detail, with ability to manage multiple priorities in a fast-paced environment
• Strong communication skills and ability to work collaboratively within cross-functional teams
• Demonstrated curiosity and willingness to learn new techniques and support evolving project needs

QUALIFICATIONS:

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical or Biomedical Engineering, or a related field, with 4–6 years (BS) or 2–4 years (MS) of relevant industry experience in the biopharmaceutical industry
• Demonstrated experience executing experiments independently in a fast-paced industry setting
• Familiarity with electronic lab notebooks (e.g., Benchling) highly desired

ABOUT THE ROLE

The Sr. Scientist LNP Formulation & Process Development will contribute to the development and optimization of nChroma’s Lipid Nanoparticle (LNP) formulations and collaborate with both internal research teams and external CROs/CDMOs to support multiple programs spanning early research and development. 

RESPONSIBILITIES

• Leverage both internal team and external CROs to optimize and produce high quality LNPs to support efforts spanning early research and development.
• Provide SME support for external production with our CDMO partners.
• Lead from the bench and contribute to a high-performing Formulation & PD team, including initiating excellent laboratory and documentation practices, and providing mentorship and development opportunities for junior team members.
• Contribute as CMC representative for GMP production support & regulatory filings as needed. Collaborate with key stakeholders from research, drug substance, analytical development, pharmacology and other internal functions to support program, department, and corporate goals.

SKILLS & COMPETENCIES:

• Hands on experience with LNP formulation including optimization, conjugation, scale-up.
• Direct managerial experience.
• 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 culture.

QUALIFICATIONS:

• 4-5 years in the biopharmaceutical industry with a proven track record with nucleic acids delivery, LNP formulation and scale up, including tech transfer to GMP suites.
• Advanced degree in Chemistry, Biophysics, Biochemistry, Bioengineering, or related life sciences with strong scientific background.
• Preferred in-depth experience with analytical assays for LNP characterization.
• Experience providing guidance and mentorship to junior scientists.
• Experience supporting development programs, including communicating between CMC and Program Teams.

The salary range for this role is $145K - $175K

ABOUT THE ROLE 

The Associate Director/Director, Regulatory Strategy will oversee the management, coordination and execution of regulatory activities for nChroma’s early development programs.  This position supports nChroma’s regulatory efforts and partners with the nonclinical, clinical development, and clinical operations functions, as well as other regulatory team members.  This role reports into the VP Regulatory Affairs. 

RESPONSIBILITIES 

• Responsible for coordinating and driving regulatory submissions, including submission teams and timelines, for assigned programs 

• Represent regulatory function on cross-functional teams  

• Support US, EU, and global clinical trials including the preparation of initial INDs/CTAs and amendments, responses to agency questions, and maintenance activities. 

• Support development and implementation of regulatory strategies to facilitate the progress of programs through all phases of development 

• Collaborate with cross-functional teams to generate and refine the product development strategy 

• Ensure regulatory strategies align with business goals and meet Health Authority requirements. 

• Actively monitor regulatory policy and intelligence and disseminate information to teams; contribute to internal process and policy improvements. 

SKILLS & COMPETENCIES: 

• Experience in gene therapy, gene editing and/or RNA therapeutics strongly preferred 

• In-depth knowledge of global regulations, ICH/GMP requirements, CTD format. 

• Thorough understanding of drug development process and the pharmaceutical industry including global regulatory requirements, guidance, accelerated regulatory review paths, and policy trends  

• Ability to work independently in a fast-paced environment  

• Ability to effectively collaborate in a dynamic, cross-functional environment to meet each program’s critical regulatory milestones  

• Excellent communication skills, regulatory writing skills and willingness to share knowledge and lessons learned with strong attention to detail  

QUALIFICATIONS: 

• B.A. and/or M.S. with at least seven years of relevant experience within the biotech or pharmaceutical industry. Minimum of 5 years in regulatory affairs in a clinical-stage and/or commercial biotechnology company. 

The salary range for this role is $180k - $235k