Serif Biomedicines | Cambridge, MA Associate Director, LNP Manufacturing

Serif Biomedicines is a privately held, early-stage biotechnology company developing a novel approach to gene therapy that can address currently untreatable diseases.

Serif was founded by Flagship Pioneering, an innovation enterprise that conceives, creates, resources, and grows first-in-category life sciences companies. Flagship Pioneering has created over 100 groundbreaking companies over the past twenty years, all of which are pioneering novel and proprietary biological, industrial, and engineering approaches to solve major needs in human health and sustainability. These companies include Moderna (MRNA), Syros Pharmaceuticals (SYRS), Seres Therapeutics (NASDAQ:MCRB), Generate Biomedicines, Tessera Tx, Evelo Biosciences (EVLO), and Indigo Agriculture.

We are seeking an outstanding Associate Director to join us in ideating and building the next generation of Programmable Medicines and lead a team of talented scientists and engineers. We’re looking for strong scientific leadership skills, a strong drive to innovate, and deep domain experience in lipid nanoparticle manufacturing and scale up
. More broadly, we’re looking for an individual who brings scientific rigor, passion for leadership and mentoring of a diverse team, obsessive attention to detail, intellectual curiosity, enthusiasm, and a desire to innovate in a highly collaborative environment. This individual will have the opportunity to work in a dynamic and fast-paced entrepreneurial environment, working as part of a highly motivated and growing team.

• Lead LNP scale-up from small R&D formulations to NHP scale in support of a development candidate. This merges the first bullet and the "ensure successful scale-up of drug product formulation and purification unit operations" bullet.
• Drive upstream and downstream process development
  , including mixing platforms (T-mix, impingement), TFF, and freeze/storage buffer optimization.
• Scale targeted LNPs (tLNPs), including conjugation, purification, and associated analytics.
• Run micro- to mid-scale formulation on microfluidics platforms (e.g., Nano Assemblr) to support platform advancement alongside cross-functional partners.
• Integrate QC profiling and method development (DLS, HPLC/CAD, LC-MS, encapsulation distribution assays) into process development.
• Lead and mentor a team of scientists and engineers, and partner across departments to deliver for in vivo studies.

• Ph.D. in chemistry, chemical engineering, biochemistry, or biomedical engineering, plus relevant industry experience
• Hands-on experience scaling nucleic acid LNP formulations across upstream, downstream, and analytics
• Working knowledge of mixing platforms (T-mix, impingement, microfluidics) and TFF
• Familiarity with LNP analytical methods (DLS, HPLC/CAD, LC-MS, encapsulation assays)
• Solid understanding of lipid and LNP design principles, stability, and their impact on critical product attributes
• General understanding of molecular biology and nucleic acid therapeutics
• Experience managing and mentoring research associates and junior scientists

• Experience scaling in a GMP environment and managing CDMOs
• Experience taking LNPs to the clinic, including agency interactions
• Experience with tLNP conjugation at scale
• Lipid synthesis, purification, and compositional analysis

Flagship is an experiment in institutional, entrepreneurial, and innovation practiced in the context of a small company with an insurgent mindset. We are seeking individuals with an entrepreneurial spirit, strong communication skills, and comfort in working in and contributing to a dynamic and cross-functional team environment.

At Flagship, we recognize there is no perfect candidate. If you…