Associate Director, mRNA DS Process Development

Company Description

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We are a privately held, stealth-mode start-up biotechnology company developing lipid nanoparticle–based approaches to address unmet medical needs.

The Role

We are seeking a hands-on and strategic Associate Director to lead mRNA drug substance (DS) process development and internal production. This role is fully focused on the entire mRNA DS workflow from DNA template (plasmid DNA and cell-free DNA) through in vitro transcription (IVT), filtration and purification, and scaling processes from milligram to multi-gram. The Associate Director will build and run internal mRNA production capacity to supply discovery and IND-enabling studies, and will lead scale-up and technology transfer to internal GMP manufacturing and external CDMOs to support clinical programs. This person will lead the mRNA DS development team and partner closely with LNP/drug product, analytical, CMC, and quality teams across global sites to deliver robust, scalable, and regulatory-ready mRNA processes.

Roles and Responsibilities

mRNA Process Development, Scale-Up, Technology Transfer for GMP Manufacturing

• Own end-to-end development, optimization, and scale-up of mRNA DS processes from bench to pilot scale (multi-liter), producing mg to multi-gram quantities.
• Own process characterization and establish critical process parameters (CPPs) and in-process controls; design and execute process development studies including DoE-based optimization, hold-time studies, and process robustness evaluations.
• Partner with construct design teams to provide manufacturability input on new sequences, including payload size, modification chemistry, secondary structure, and DNA template design.
• Identify, evaluate, and implement new process technologies to improve yield, purity, cost, and scalability.
• Lead technology transfer of mRNA DS processes to internal GMP manufacturing and to external CDMOs; author batch records, process descriptions, and tech transfer packages.
• Manage CDMO relationships through engineering, GMP, and process validation campaigns, including person-in-plant support, deviation and investigation support, and change control.

Internal Production Capacity

• Build and lead internal mRNA production capability to reliably supply research- and toxicology-grade mRNA for discovery and IND-enabling studies.
• Lead execution of internal production campaigns, including planning, scheduling, batch documentation, and release testing handoffs, to meet pipeline timelines.
• Establish phase-appropriate documentation and controls to enable a smooth transition from research production to internal GMP manufacturing.

Leadership & Cross-Functional Partnership

• Lead, hire, and mentor the mRNA DS development team; develop junior scientists and foster a culture of scientific rigor, accountability, and continuous improvement.
• Represent mRNA DS in cross-functional program teams and collaborate effectively with teams across global sites; shape long-term mRNA process development and manufacturing strategy.
• Partner closely with the LNP formulation and drug product team to co-optimize DS attributes for both platform and pipeline programs.
• Collaborate with analytical development to define critical quality attributes (CQAs) , develop in-process assays, and establish release specifications aligned with regulatory expectations.
• Work closely with the CMC team to support IND filings, authoring and reviewing DS sections, process development reports, and responses to agency questions.

Required Qualifications

• PhD in chemical engineering, biochemistry, biochemical engineering, chemistry, molecular biology, or a related discipline with 6+ years, or MS with 10+ years, of progressive industry experience in mRNA process development.
• Successful track record of developing scalable mRNA processes from R&D setup through GMP manufacturing at gram scale, including direct experience with technology transfer to internal GMP facilities and/or CDMOs.
• Deep knowledge and hands-on experience in plasmid DNA linearization, mRNA IVT, TFF, and chromatographic purification of mRNA.
• Strong expertise in Design of Experiments (DoE), statistical data analysis, and process characterization is a must.
• Direct experience with CMC documentation for IND-enabling activities, including process development reports, regulatory filings, and responses to agency questions.
• Demonstrated people management experience, including hiring, mentoring, and leading technical staff.
• Proven ability to work effectively in cross-functional and globally distributed teams.
• Clear, concise communicator, able to present data, process rationale, and risk assessments to cross-functional and executive audiences through oral presentation and technical writing.
• Ability to leverage literature, internal and external resources to solve problems and develop new technologies.

Preferred Qualifications

• Experience building internal GMP manufacturing capabilities is a strong plus.
• Experience with plasmid and mRNA analytical methods.
• Familiarity with LNP formulation and how DS quality impacts encapsulation and drug product performance.
• Experience with gene editing payloads, including sgRNA drug substance development.
• Experience in process automation, high-throughput process development, PAT and process modeling. xhyhwjd
• A bias toward proactive problem-solving and a collaborative mindset suited to a small, high-velocity team.

Location

San Diego, CA. This is an on-site position

What We Offer

• An opportunity to work at the forefront of RNA/DNA and LNP-based therapeutic innovation
• A collaborative, science-first culture where individual contributions are visible and impactful
• Competitive compensation and benefits package, including health, dental, vision, and life insurance 401(k) with company match