Job Information
Actalent Associate Scientist, Analytical Development LC/MS in Gaithersburg, Maryland
Description:
Associate Scientist to join our Analytical Development department group of energetic LC/MS scientists. The qualified individual should have demonstrated proficiency with development and application of HPLC and/or Size Separation based methods for phase-appropriate characterization of protein or vaccine products, including Ion Exchange Chromatography, Size-Exclusion Chromatography (SEC), residual assays via HPLC-UV or HPLC-FLD analysis. The candidate will support development and qualification of molecular separation assays, OOS investigations and troubleshooting, writing SOP, development report and technical report for testing vaccine products. The candidate will be expected to work efficiently with cross-functional teams. A good understanding of FDA and ICH guidelines and practical knowledge with assay validation is required for this position.
Responsibilities include but not limited to:
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 at NVAX and/or CMO sites.
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:
Minimum Requirements:
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.
WHY ACTALENT
Work with a dedicated career partner specialized in your healthcare skill set
We advocate on your behalf so you get what you want and need out of your job
Get performance feedback, career advice, and access to ongoing professional
development tools
Build your career and learn new skills through projects as diverse as your curiosity
You are eligible for benefits, paid-time-off, and competitive wages that are paid weekly
ABOUT ACTALENT
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
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.