We are seeking a highly motivated scientist or engineer with relevant development background to perform protein purification for our vaccine and therapeutic biologic candidates in the downstream process department. The position is a hands-on position with responsibility for purification process development and characterization. The candidate should have an in-depth understanding of protein chemistry, biochemistry and separation science technology, especially chromatography and/or cell lysis and product recovery. The candidate should also be able design consistent, scaleable, high yielding; high purity purification processes and able to readily apply statistical design of experiments (DoE) and concepts of process validation to process development. The ability to understand and interpret moderately complex data is essential and the position requires strong organizational and documentation skills.

This position will be located at our Rockville, MD facility and will report to senior management within process development.

Responsibilities include but are not limited to:

• Developing consistent, high-yielding, high-purity, scalable and economical downstream purification processes for clinical phase RSV vaccine and other biologic product candidates.
• Independent execution of bench-scale experiments to support process development activities such as process optimization and characterization, development and screening of new process materials/equipment/technologies, resolution of manufacturing deviations, etc.
• Identifying and resolving complex technical problems in process development. Working with colleagues and management for planning and design stage of experimental work, resource identification, and project planning.
• Advising or providing direction to process development associates or members of project teams in the planning and execution of laboratory experimentation relating to process design, scale-up and characterization.
• Supporting and troubleshooting operations as needed in the GMP manufacturing facility. Assisting with resolution of manufacturing deviations.
• Authoring technical reports, data analysis summaries, SOPs and other technical documentation as needed
• Maintaining and monitoring process development equipment, understanding and compliance with Good Laboratory Practices and laboratory safety procedures, providing training and support to the junior level staff in the laboratory.
• Collaborating and coordinating with colleagues from Discovery, Process Development, Analytical Development, Technology Transfer, Manufacturing, and QA/QC teams.
• Supporting tech transfer, validation, and other processes
• Presenting results of work, interpreting data, and drawing conclusions regarding presented material and nature of work
• This position is expected to be both hands on in the laboratory and acting as a technical lead / support role for all process development associate levels.

Minimum Requirements:

• M.S. with 4+ years of experience or B.S. with 8+ years of experiences in pharmaceutical or biotech industries R&D department.
• Strong downstream purification experience in an industrial setting, especially for protein based biotechnology products; direct experience with virus-derived recombinant products and/or viral particles is a plus.
• Must have extensive hands on experience with ÄKTA explorer and knowledge of various protein purification techniques including ion exchange, size exclusion, affinity and hydrophobic interaction chromatography, as well as normal and tangential flow filtrations.
• Experience with cell culture harvest activities such as lysis and centrifugation is a plus.
• Experience with ÄKTA pilot or HPLC is a plus.
• Knowledge and experience with statistical design of experiments (DoE) and JMP software is a plus.
• Should be capable of performing multiple functions in a fast paced environment. Strong technical protocol/report writing and good organization skills are required.
• Knowledge of regulatory guidelines and cGMP requirements is required;
• Excellent record keeping abilities to adequately record, analyze and document data generated in support of regulatory requirements.
• Demonstrated verbal and written skills in communicating regulatory and technical information.

Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.