Associate Director / Director, Formulation Development

Pivotal • San Diego, CA

2d • Onsite

About The Position

We are an innovative, stealth-mode biotech focused on developing best-in-class delivery for in vivo gene editing. We are seeking an experienced formulation leader to join our team as Associate Director / Director, Formulation Development. This individual will lead and build a formulation sciences team responsible for the design, development, optimization, and scale-up of lipid nanoparticle (LNP) drug delivery systems for gene editing therapeutics. The successful candidate will set the scientific and strategic direction for LNP formulation, drive process development from research through GMP manufacturing, and serve as a key cross-functional partner to preclinical, CMC, and clinical teams. Title level and salary will be commensurate with experience.

Requirements

• Ph.D. in Pharmaceutics, Chemical Engineering, Chemistry, Biomedical Engineering, or a related field; or M.S. with commensurate industry experience.
• 10+ years of pharmaceutical formulation experience, with at least 5 years focused on lipid nanoparticle or related nanoparticle drug delivery systems.
• 3+ years of direct people management experience, with a demonstrated track record of building and developing high-performing teams.
• Deep expertise in LNP formulation design, process development, and analytical characterization (DLS, zeta potential, cryo-TEM, encapsulation assays).
• Experience advancing formulation programs from research through GMP manufacturing and IND/CTA filing.
• Strong understanding of CMC regulatory requirements for biologics or gene therapy products (ICH Q8–Q12).
• Proven ability to manage CDMO relationships and oversee technology transfer.
• Excellent scientific communication skills, including authorship of regulatory documents, publications, and executive-level presentations.
• Eligible to work in the United States for any employer without current or future sponsorship.
• Able to work onsite in the lab, based on the location listed for the position (either San Diego, CA or Boston, MA).
• Direct candidates only and not from a third party, i.e., staffing agency.

Nice To Haves

• Direct experience with mRNA or CRISPR/Cas9 payload formulation in LNPs.
• GMP manufacturing experience for LNP-based drug products, including process validation and commercial-scale production.
• Experience with targeted or functionalized nanoparticle systems (e.g., antibody-conjugated LNPs, ligand-targeted delivery).
• Familiarity with gene therapy or gene editing regulatory pathways and FDA/EMA interactions.
• Track record of scientific publications and/or patents in the LNP or nucleic acid delivery field.

Responsibilities

• Lead and manage a formulation sciences team, setting priorities, mentoring scientists, and fostering a culture of scientific rigor and innovation.
• Define the formulation development strategy for LNP-based gene editing programs, from early research through IND-enabling activities and clinical supply.
• Represent formulation sciences in cross-functional program teams and leadership discussions; contribute to program-level decision-making and risk assessment.
• Establish and maintain best practices, SOPs, and quality standards for formulation development workflows.
• Oversee the design and optimization of LNP formulations, including ionizable lipid selection, helper lipid ratios, PEG-lipid strategies, and N/P ratio tuning for mRNA and gRNA payloads.
• Drive process development and technology transfer for microfluidic mixing, tangential flow filtration, and downstream purification at research, pilot, and GMP scale.
• Direct analytical characterization of LNP systems using DLS, zeta potential, cryo-TEM, HPLC, and encapsulation efficiency assays; ensure robust in-process and release testing strategies.
• Lead formulation stability programs, including accelerated and real-time studies, and define storage and handling conditions for drug product.
• Evaluate and implement novel formulation approaches, materials, and platform technologies to improve potency, tolerability, and manufacturability.
• Partner with preclinical, biology, and clinical teams to design and interpret in vitro and in vivo studies evaluating LNP formulation performance, biodistribution, and safety.
• Manage relationships with CDMOs and external partners for formulation and drug product manufacturing; oversee technology transfer and batch disposition.
• Author and review CMC sections of regulatory filings (IND, CTA, BLA) and respond to health authority inquiries related to formulation and drug product.
• Stay current with the evolving LNP and nucleic acid delivery landscape; represent the company at scientific conferences and through publications.

Benefits

• Competitive salary, equity, and comprehensive benefits package.
• Opportunities for professional growth and leadership development.
• Fast-paced, collaborative, and innovative work environment.
• Medical, Dental, Vision, Life, Disability, a 401k Match of 4%, Paid Time Off and Equity.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior