Senior Scientist/Principal Scientist, Formulation and Process Development
Capstan Therapeutics, Inc. is a privately held biotechnology company dedicated to advancing in vivo cell reprogramming. The core platform technology comprises proprietary targeted lipid nanoparticles (tLNPs) that are composed of LNPs conjugated with a recombinant protein binder, such as a monoclonal antibody. tLNPs are designed to deliver payloads, including mRNA or gene editing tools, capable of reprogramming specific cell types in vivo. The platform technology has the potential to generate transformative therapies with possible applications across a broad range of disease areas, including oncology, autoimmune disorders, fibrosis, and monogenic blood disorders.
THE OPPORTUNITY
We are currently searching for a highly motivated and innovative Formulation Scientist to join our Formulation/Process Development team. In this role, you will be responsible for leading projects focused on formulation design and optimization, formulation process development and characterization of the most exciting CAR- tLNP drug product, to support emerging research pipelines focused on autoimmune, oncology, fibrosis and inflammation-related diseases, as well as blood monogenic disorders.
This position will report into the Senior 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

• Independently design 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 scientists and/or 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 characterization of tLNP 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 company 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.

Qualifications

• Ph.D. preferred in Chemistry, Biochemistry, Bioengineering, or Pharmaceutical Sciences with a minimum of 5-8 years in design and development of nanoparticle-based drug delivery systems or complex biologics. BS/MS with equivalent experience, training, and background.
• Experience with lipid nanoparticle formulation and purification processes, antibody conjugation chemistry, 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 formulation drug products.
• 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 required for this position.

Salary & Benefits Offerings

• $150,000 – $200,000 per year depending on experience
• Performance bonus & Equity 
• 401k Match Program 
• Healthcare Coverage 
• Dental Coverage 
• Vision Coverage 
• Optional Dependent Care Account 
• Flexible Spending Account (FSA) 
• Paid Time Off (PTO) 
• Company Paid Holidays 
• Paid Sick Leave 
• Onsite Fully Stocked Kitchens 

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.

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