Scientist I/II, Analytical Development

About the role

Artivabio is seeking a dedicated Scientist I/II to join our Analytical Development team in San Diego, California. This position is ideal for individuals who are about advancing the field of biotechnology and have a strong foundation in analytical techniques. The successful candidate will play a critical role in the development and optimization of analytical methods to support our innovative therapeutic programs. This role offers an to contribute to research and development in a collaborative and dynamic environment.

Key facts

What you'll do

• Develop and validate analytical methods for characterizing biologics, including proteins, nucleic acids, and other therapeutic modalities.
• Conduct stability studies and analyze data to ensure product quality and compliance with regulatory standards.
• Collaborate with cross-functional teams, including formulation scientists, quality assurance, and regulatory affairs, to support product development from early stages through to clinical trials.
• Perform routine laboratory experiments, including HPLC, mass spectrometry, and other relevant techniques, to assess the quality and efficacy of therapeutic candidates.
• Document experimental procedures and results in compliance with Good Laboratory Practices (GLP) and maintain accurate laboratory records.
• Troubleshoot and optimize existing analytical methods to enhance efficiency and reliability.
• Prepare technical reports and presentations to communicate findings to internal stakeholders and external partners.
• Stay current with industry trends and advancements in analytical technologies to continually improve departmental capabilities.
• Participate in the training and mentoring of junior scientists and interns, fostering a culture of learning and collaboration.
• Contribute to the preparation of regulatory submissions, ensuring that analytical data is and meets the required standards.
• Engage in continuous improvement initiatives to enhance laboratory operations and workflow efficiency.
• Support the implementation of new technologies and methodologies to advance the analytical development process.

Requirements

• A Master's degree or Ph.D. in Analytical Chemistry, Biochemistry, or a related field with relevant experience in the biotechnology or pharmaceutical industry.
• A minimum of 2 years of hands-on experience in analytical method development and validation for biologics.
• Proficiency in a variety of analytical techniques, including HPLC, mass spectrometry, and electrophoresis.
• Strong understanding of regulatory guidelines related to analytical testing, including ICH and FDA requirements.
• Excellent problem-solving skills and the ability to work independently as well as collaboratively within a team.
• Strong organizational skills with the ability to manage multiple projects and meet deadlines in a fast-paced environment.
• Exceptional written and verbal communication skills, with the ability to present complex data clearly and concisely.

Nice to have

• Experience with bioassays and immunoassays for potency testing of biologics.
• Familiarity with statistical software for data analysis and interpretation.
• Previous experience in a start-up environment or small biotech company.
• Knowledge of quality management systems and experience with audits.
• Publications in peer-reviewed journals related to analytical development or biopharmaceuticals.

Skills & tools

• Proficient in laboratory software and data analysis tools, including Empower, ChemStation, or similar platforms.
• Familiarity with laboratory information management systems (LIMS) for data tracking and management.
• Strong computational skills and experience with programming languages such as Python or R for data analysis.
• Knowledge of good laboratory practices (GLP) and good manufacturing practices (GMP).

Practical notes

• This position is based in San Diego, California, a city known for its beautiful weather and thriving biotech community.
• Candidates must be eligible to work in the United States; visa sponsorship is available for qualified individuals.
• Artivabio is committed to fostering a diverse and inclusive workplace, and we encourage applications from individuals of all backgrounds.
• Interested candidates should apply through the provided link to submit their resume and cover letter.

META

Company: Artivabio

Title: Scientist I/II, Analytical Development

Listed

location: San Diego, California

Job type: Full-time

Apply URL: https://artivabio.bamboohr.com/careers/216