Description:

• Develop HPLC related method for the separation and identity of related proteins and/or impurities in nanoparticle vaccine products.

• Responsible for leading experimental designs to characterize Drug Substance and Drug Product materials for various batches generated.

• Follow SOP to test in-process samples using HPLC to support process development and stability studies of nanoparticle vaccines.

• Responsible for drafting qualification and/or validation protocols for test methods to evaluate in-process samples.

• Participate in cross-functional workflows and provide scientific guidance to teams.

• Apply new cutting-edge technologies to improve throughput for in-process testing and enhance capability of product characterization.

• Perform method transfers to QC and other groups and external partners.

• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

• Maintain effective communication within Analytical Development and cross-functional teams.

• Present scientific findings at internal and external meetings.

Additional Skills & Qualifications:

• MS in analytical science, chemistry, biochemistry, or related field with 4+ years of industry experience in biopharmaceutical and/or vaccine development.

• BS in analytical science, chemistry, biochemistry, or related field with 6+ years of industry experience in biopharmaceutical and/or vaccine development.

• Ability to critically analyze data using statistical tools and to compile and review technical reports.

• Ability to define priorities and process to get things done.

• Knowledge and expertise in the principles and practice of current Good Manufacturing Practices (GMPs) is preferred.

• Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.

• Good understanding of statistical tools and knowledge of DOE (Design of Experiments) and QbD (Quality by Design) principles is a plus.

• Strong communication, presentation, and writing skills.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.