Sr.Scientist, Drug Product Development Lead

Posted 03 June 2021
Salary Up to £0.00 per annum
Location
Job type Permanent
ReferenceBBBH118124_1622760480
Contact NameBecky Krage

Job description


We are a fully integrated AAV engineering and gene therapy company poised to create the next generation of innovative genetic therapies with life-changing potential for patients with grievous unmet medical needs.

We leverage our proprietary high-throughput, data science driven AAV engineering platform to create viral vectors with cell-type and tissue level specificity, overcoming many of the biological limitations of early gene therapy efforts. Combined with our in-house preclinical and manufacturing expertise, we are positioned to create the next generation of AAV delivered gene therapies, dramatically changing the lives of patients.

We are founded on the idea that diverse backgrounds and skill sets combine to create an environment that stimulates innovation and creativity, enabling us to grow into a leader in the AAV gene therapy space. Our leadership team is comprised of the scientific founders that developed the underlying intellectual property, and experienced industry veterans with a track record for brining transformative drugs to market. Together with our partners, we will combine next generation engineered capsids with cutting edge gene editing and delivery modalities to bring novel medicines to patients that need them. Our research and development labs, offices, and manufacturing space are located in Newbury Park, near the Amgen campus.

Senior Scientist/Group Lead - AAV Drug Product Development

We are looking for a motivated Senior Scientist/ lead to join the Process Development team. The goal of this position is to establish the drug product and formulation capabilities for Capsida's novel AAV products. Under the guidance of senior leadership, you will lead a team focused on identifying key formulation and product quality attributes impacting stability and storage of AAV products. A successful candidate will have strong technical, organization, and leadership skills, and work seamlessly with a team.

Major Responsibilities

  • Lead the drug product team in identifying optimal formulations, storage temperatures, and primary packaging for novel capsids
  • Design and implement device compatibility studies for CMC programs
  • Collaborative with analytical development and QC on appropriate methods and testing procedures to evaluate capsid stability and critical quality attributes
  • Work with manufacturing and quality teams to establish and supporting drug product filling operations
  • Assist in the preparation of regulatory documents.
  • Work with external partners to evaluate new technologies
  • Maintain accurate and detailed laboratory notes
  • Author technical materials, procedures, protocols, and reports
  • Plan, schedule, and execute on experimental designs in collaboration with senior leadership
  • Conduct troubleshooting experiments
  • Perform additional tasks as assigned

Essential Requirements:

  • M.S. or Ph.D in a life sciences discipline with a minimum of 3-8 years of relevant experience in a biotechnology, pharmaceutical, or academic setting.
  • Experience with formulation or stability assessment in an industrial laboratory
  • Experience developing and optimizing protocols or standard operating procedures.
  • Previous involvement in writing method development reports or regulatory documentation
  • Experience with a variety of scientific data analysis software, including but not limited to Microsoft Office, JMP, Prism, Snapgene (or similar cloning software), ELNs and the Adobe suite of products
  • Excellent organizational and collaborative skills, with the ability to design and troubleshoot experiments with minimal supervision or as part of a group.
  • Prior experience working with gene therapy vectors strongly preferred
  • Must be eligible to work in the U.S.

Additional Preferred Skills:

  • Experience with AAV vectors, virus or vaccine testing preferred
  • Direct experience with biophysical methods including HPLC or CE
  • Previous experience leading a team with direct reports

Compensation and Benefits:

The well-being of our employees and their families is of the highest importance. As such, we
offer a competitive salary and exceptional benefits, including generous stock options, medical,
dental, vision, disability, life insurance, and significant PTO.

Additionally, we offer:

  • Relocation compensation
  • Fully stocked kitchen
  • Social lunches, happy hours, and other events on a regular basis

We are an equal opportunity employer. All applicants will be considered for employment
without attention to age, race, color, religion, sexual orientation, gender identity, national origin,
veteran or disability status, or any classification protected by federal, state, or local laws