Principal Scientist, Analytical Development

About the role

Artivabio is seeking a Principal Scientist to lead our Analytical Development team in San Diego, California. This pivotal role will focus on the development and validation of analytical methods to support our innovative gene therapy programs. The ideal candidate will bring extensive experience in analytical chemistry and a passion for advancing therapeutic solutions. You will collaborate with cross-functional teams to ensure the successful progression of our projects from early development through to clinical trials.

Key facts

What you'll do

• Lead the development and validation of robust analytical methods for characterizing gene therapy products, including but not limited to potency, purity, and identity assays.
• Design and execute experiments to support the analytical characterization of drug substances and drug products, ensuring compliance with regulatory standards.
• Collaborate with formulation scientists to develop analytical strategies that support formulation development and stability studies.
• Provide scientific leadership and mentorship to junior scientists and team members, fostering a culture of innovation and excellence within the team.
• Prepare and review technical documents, including method validation reports, stability protocols, and regulatory submissions, ensuring high-quality standards are met.
• Stay abreast of industry trends and advancements in analytical techniques, integrating new methodologies into the lab as appropriate.
• Work closely with Quality Assurance and Regulatory Affairs teams to ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Participate in cross-functional project teams, contributing analytical insights to support project milestones and timelines.
• Troubleshoot and resolve technical issues related to analytical methods and instrumentation, ensuring minimal disruption to project timelines.
• Conduct training sessions for team members on new analytical techniques and best practices, enhancing the overall skill set of the team.
• Engage in scientific discussions and presentations at internal and external meetings, representing Artivabio's analytical capabilities.
• Contribute to the preparation of scientific publications and presentations to disseminate findings and advancements in analytical development.

Requirements

• Ph.D. in Analytical Chemistry, Biochemistry, or a related field with a minimum of 5 years of experience in pharmaceutical or biotechnology industries.
• Proven track record in developing and validating analytical methods for biologics, particularly gene therapies or similar modalities.
• Strong knowledge of regulatory guidelines (FDA, EMA) related to analytical development and product characterization.
• Experience with a variety of analytical techniques, including HPLC, mass spectrometry, and ELISA, among others.
• Excellent problem-solving skills and the ability to work independently as well as collaboratively in a team environment.
• Strong written and verbal communication skills, with the ability to convey complex scientific concepts clearly to diverse audiences.

Nice to have

• Familiarity with Quality by Design (QbD) principles and their application in analytical method development.
• Experience in managing projects and leading teams in a fast-paced, dynamic environment.
• Knowledge of bioanalytical method development for gene therapy products.
• Previous experience in a start-up or early-stage biotech company is a plus.

Skills & tools

• Proficient in using analytical software and tools for data analysis and interpretation.
• Strong organizational skills with attention to detail and the ability to manage multiple projects simultaneously.
• Familiarity with laboratory information management systems (LIMS) and electronic lab notebooks (ELN).
• Competence in statistical analysis software for method validation and data interpretation.

Practical notes

• The position is based in San Diego, California, a vibrant hub for biotechnology and life sciences.
• Artivabio offers a competitive salary and benefits package, including health insurance, retirement plans, and opportunities for professional development.
• Candidates must be eligible to work in the United States; visa sponsorship is available for qualified applicants.
• Interested candidates can apply through the Artivabio careers page at https://artivabio.bamboohr.com/careers/215.

Join us at Artivabio and contribute to groundbreaking advancements in gene therapy. We are committed to fostering an inclusive and diverse workplace where every team member can thrive. If you are passionate about analytical development and eager to make a difference in patients' lives, we encourage you to apply!