Scientist II/Senior Scientist, Formulation & Process Development

Capstan Therapeutics is developing a targeted delivery platform and therapeutics to reprogram immune cells in vivo in a scalable and controlled format, for a broad range of disease categories. The core technology originating from University of Pennsylvania comprises Targeted Lipid Nanoparticles (tLNPs) to enable off-the-shelf immunotherapies, with tight control of dosage and of activity of engineered cells. The objective is to advance transformative first-in-class and best-in-class products for oncology, fibrosis and inflammation-related diseases, and blood monogenic disorders. Our dynamic start-up is founded by pioneers in the field of immunotherapy, regenerative medicine and drug delivery including experienced industry leaders and academic faculty members from U Penn.

In summary, Capstan Therapeutics aspires to become the leader of a new revolution in medicine, opening the avenue of in vivo reprogramming of the immune system and bringing this treatment modality to a broad range of medical needs. With locations in Philadelphia and San Diego, we are looking for talented individuals to join us.

The Opportunity

We are currently searching for a highly motivated and innovative Formulation Scientist to join our newly formed Formulation/Process Development team. In this role, you will be responsible for leading projects focused on formulation design, development, scale-up and characterization of the most exciting CAR-tLNP drug product, to support emerging research pipelines focused on oncology, fibrosis and inflammation-related diseases, and blood monogenic disorders.

This position will report into the Director of Drug Product Development and Manufacturing based at our San Diego office. This role will involve hands-on laboratory work as well as mentoring and training junior scientists. All duties will be performed in compliance with Capstan’s standard operating procedures (SOPs).

Responsibilities and Duties:

• Independently designs and develops lipid based nucleic acid formulations with targeting modalities for innovative drug products. Ensure successful scale up of formulation production and purification unit operations from bench scale to larger scale manufacturing.
• Provides technical guidance internally to the formulation, analytical and manufacturing teams on the formulation methodologies and issues.
• Leads investigations of aberrant results, determination of root causes and recommends action plan
• Routinely acts as a group leader on formulation projects and mentor to a small group of research associates.
• Demonstrate creativity and independence in developing, optimizing and advancing process platform for various complex nucleic acid formulations.
• Direct and manage formulation support for stability and bio-evaluation studies for various projects
• Develop and/or contribute to development of analytical methods for physico-chemical characterization of drug product.
• Prepares scientific reports, technical reports, presentations and experimental protocols as needed
• Work with other formulations and/or colleagues in other department as a team, deliver high quality results in an accurate and a time sensitive manner.
• Represent formulation development function in various project team meetings and contribute to overall project goals and deliverables.
• Contribute to formulations/process development sections of regulatory filings (IND, NDA etc.)
• Review scientific literature, patents, scientific abstracts to stay up to date on latest in the field. Provide scientific expertise in the organization with special emphasis on lipid nanoparticle-based drug targeting delivery systems for nucleic acids
• Demonstrate scientific excellence through filing patents and publishing scientific articles in peer reviewed journals
• All other tasks and duties assigned as perceived and agreed upon by management.

Requirements/Qualifications:

• Must have a PhD in Chemistry, Biochemistry, Bioengineering, or Pharmaceutical Sciences with 2-5 years of industry experience in design and development of nanoparticle-based drug delivery systems or complex biologics
• Experience with lipid nanoparticle formulation and purification processes, or experience with process development, engineering and manufacturing of biologic drug product processes are highly desired.
• Expertise in developing liquid, frozen and lyophilized formulations of lipid based nucleic acid formulations
• Expertise and knowledge in process development, scale up of formulation production and purification unit operations and tech transfer activities
• Demonstrated ability to establish new capabilities and innovate strategies in pursuit of scientific excellence. Must be an independent thinker with a passion for developing innovative formulation technologies.
• Experience with supervision, mentorship, or training of other team members.
• Good track record of scientific publications and patents in the field of lipid nanoparticle-based drug delivery systems is desired
• Must possess in depth understanding of all aspects of formulation development as well as downstream characterization including physicochemical, stability and biological evaluation.
• Experience in contributing to formulation and pharmaceutical development sections of regulatory filings is highly desirable.
• Comfortable working in a highly innovative, changing, fast-paced environment with multi-task skills is required.
• Details oriented with good organization skills, great troubleshooting skills, team player, excellent oral and written communication skills are necessary for this position.
• Ability to work in a well-lit heated and/or air-conditioned indoor office and occasional laboratory setting with adequate ventilation. Light physical activity performing non-strenuous daily activities of a productive/technical nature. May require long periods of standing/sitting.
• Manages personal and interpersonal stress, if required. Has the discipline to stay focused and complete specific tasks

If you are interested in hearing more, reach out to us. We believe that each team member will impact and improve the lives of those we work with, and those we work for—our patients.

Capstan is an equal opportunity employer. We value diversity and do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment.

Unsolicited resumes sent to Capstan from recruiters do not constitute any type of relationship between the recruiter and Capstan and do not obligate Capstan to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring managers or employees.