About the job

About Alltrna

Alltrna is the world's first tRNA platform company to decipher tRNA biology and pioneer tRNA therapeutics to treat thousands of diseases. Alltrna unlocks tRNA biology to correct disease. The company's platform incorporates AI/ML tools to learn the tRNA language and deliver diverse programmable molecules with broad therapeutic potential. Alltrna has an unprecedented opportunity to advance a single tRNA medicine to unify treatment across a wide range of diseases with the same underlying genetic mutation. Alltrna was founded in 2018 by Flagship Pioneering. For more info, visit www.alltrna.com.

Position Summary:

We are looking for an inclusive leader to build the formulations team within our growing tRNA CMC Group. The candidate will work internally with preclinical research teams on the development of lipid nanoparticle (LNP) formulations suitable for proof-of-concept preclinical studies and with external development partners on manufacture of formulations for clinical applications. In addition, the formulation lead will be responsible for establishing Alltrna's formulation capabilities, recruitment of staff and the design of tRNA drug product manufacturing processes supporting Alltrna's pipeline.

What is in this for you?

If you like a fast-paced, science driven research environment discovering how a new therapeutic modality can be shaped to meet the needs of patients suffering from serious underserved diseases- this is the role for you. You get to be part of the team that writes the playbook for developing tRNA molecules as therapeutics. You will be critical not only in ensuring that we can understand how our formulations perform in living systems but also in defining how we manufacture for our clinical programs. We operate in an open and inclusive learning environment and need nimble thinkers who can chart courses and plan experiments based upon the data that we generate together cross-functionally.

Key Outcomes:

• Support research program teams with expertise on the development and characterization of formulations of oligonucleotide/RNA molecules for in vivo studies. Direct experience with RNA and LNP formulations in a fast-moving preclinical development environment is essential.
• Manage technical projects with internal/external collaborators to drive innovative nanoparticle formulations, tissue-targeting technology, and compatibility studies to support directions for handling and administration.
• Lead cross- functional teams to transfer parenteral drug product processes to manufacturing partners (CMOs) including on-site technical support.
• Recruit and grow a team of scientists/engineers to develop formulations and drug product manufacturing processes to support the preclinical and clinical pipeline. Ability to provide direction, guidance, and mentoring to a team of scientists/engineers.
• Provide leadership support/guidance to CMC teams and subject matter expertise for global regulatory filings.

Required Skills:

• PhD (Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemical Engineering, or a related discipline) with 8+ years of direct experience in parenteral formulations for biopharmaceutical applications.
• Expert level understanding of nucleic delivery and formulation science, current modalities and their applications.
• Deep expertise in the formulation of parenteral oligonucleotide products and in drug product development/cGMP manufacture. Proven track record of successful transfer of drug product processes to CMO partners.
• Expertise in analytical methods used in the characterization of LNP formulations for pharmaceutical products.
• Excellent written and verbal communication skills with emphasis on effective presentations and publications.
• Strong organizational skills and the ability to administer a project to ensure timely completions (including budgets, timelines, milestone tracking, etc.).
• Highly skilled in Word, Excel, PowerPoint, and other tools. Knowledge of statistical software and applications for design of experiments and process modeling.

Our Core Values

WE GIVE IT OUR ALL, EVERYDAY, FOR PATIENTS EVERYWHERE. WE ARE ALLTRNA.

Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

Alltrna was founded by Flagship Pioneering, an innovation enterprise that conceives, resources and grows first-in-category life science companies. The firm's institutional innovation foundry, Flagship Labs, is where teams of scientific entrepreneurs systematically evolve ideas and turn previously undiscovered areas of science into real-world ventures. Flagship has created over 100 scientific ventures resulting in >$19 billion in aggregate value, 500+ issued patents, and >50 clinical trials for novel therapeutic agents. Flagship's portfolio companies include Moderna, Rubius Therapeutics, and Indigo Agriculture.