Clinical Product Manufacturing Lead

Come lead clinical product manufacturing at HelixNano, a rapidly growing clinical-stage mRNA startup!

HelixNano is backed by some of the world’s most visionary investors, including Y Combinator, Sam Altman, Chief Scientist of Google+DeepMind Jeff Dean, Thiel Capital, and Founders Fund. We build next-generation mRNA technologies, vaccines and therapies to augment the immune system's power to fight disease.

We are tackling cancer head-on with unprecedentedly potent cancer vaccines targeting metastatic tumors, and have an ongoing Phase 1 clinical trial for a COVID vaccine designed to safeguard those with weakened immune systems.

We will be taking several product candidates to the clinic in the next two years, all while continuing to invent and integrate new ways of making DNA, mRNA, and LNPs at clinical scale and quality. We are hiring a Manufacturing Lead to perfect our manufacturing processes and strategy and creatively remove blockers along the way. This is a unique opportunity to join a startup just hitting escape velocity,  and to have generational impact on human health.

The Role  

You will be in charge of anything touching HelixNano’s mRNA manufacturing. Take the processes and external relationships we have in place and make tweaks to create a seamless product manufacturing machine that we can rely on repeatedly as we bring even more drug products through. At times we’ll look to you to re-design a process entirely or build a new one from scratch, innovating from within.

You’ll work closely with a HelixNano project manager and with several technical partners, including our external CDMOs and analytical testing labs, our QA team & and the R&D teams working on process development. You will rely on your expertise to perfect our processes, make decisions on how we make our products and who we partner with to make it, and align the relevant internal and external team members on process and strategy.

Here are some overall responsibilities we expect you will handle in this role:

  • Oversee manufacturing activities at external partner/vendor sites (some travel required, mostly to New Jersey, ~4X per year.)

  • Lead the tech transfer process from process development to GMP production across our CDMO partners.

  • Set the strategy for the timing and scope of any internal GMP build-outs.

  • Review and provide technical feedback on manufacturing documents; serve as a node of knowledge of HelixNano’s mRNA platform.

  • Leadership role: manage relationships with many partners (inside HelixNano, HelixNano and partner QA teams, technical leads at our external CDMO, various other vendors); communicate effectively and delegate to ensure alignment and forward progress.

To give a better sense of the role, here are situations you might experience over the next year:

  • R&D develops a therapeutic that involves complex (~1e3) libraries of mRNA, and wants to make large batches for preclinical toxicology and NHP efficacy studies. You are tasked with rapidly adapting the existing manufacturing process to to enable multiplexing, including identifying and fixing methods that generate unacceptable biases, and finding or developing library-compatible QC strategies for DNA, mRNA, and LNP-formulated mRNA.

  • You have built an internal system for managing reagent inventory both internally and across all partners involved in product manufacturing. However, you notice that a specific team at a CDMO partner instead uses their own internal tool, syncing with the HelixNano tool too rarely to be useful (every ~2 months). You need to address by first figuring out why they are not using the HelixNano system, in case this identifies gaps in our system or processes and we need to tweak them. Similarly, you need to check whether any processes are breaking down at the CDMO, and advise them on how to address this.

  • You are deploying a more automated, computer-vision-based robotics process in GMP manufacturing. You end up having to liaise with OSHA to ensure that the system is safe for the technicians working in the clean room.

What we are looking for

No strict prerequisites - some of the best people we’ve worked with have come from nontraditional paths.  Having said that, the strongest candidates will likely have a couple of years of experience in nucleic acid and/or biologics process development/process engineering, a good understanding of GMP practices and/or tech transfer to GMP production, and may be familiar with LNP formulation and fill/finish.

Importantly, we’re looking for someone who is:

  • Great at recognizing and resolving gaps in technical and operational processes.

  • Skillful at context switching — able to operate simultaneously in the minutiae as well as in big-picture mode.

  • Energized by seemingly insurmountable problems and advocates for creative and even contrarian solutions.

  • A strong leader and amazing communicator who can bridge many worlds and viewpoints, and effectively hold all together to drive decision making on behalf of HelixNano.

If this sounds like you, we’re really excited to meet you. Reach out to jobs@helixnano.com and send us your resume (no need for a cover letter!) and we'll be in touch.

Come join us!

Relocation assistance provided if you’re moving to Boston (lump sum).

HelixNano is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, gender, sexual orientation, national origin, disability status, protected veteran status or any other legally protected status.

Open to visa sponsorship.