Aerotek Scientist, Downstream Process Development- Nanoflu in Gaithersburg, Maryland
Scientist to join our Downstream Process Development Department - NanoFlu in Gaithersburg, MD. Qualified individuals will play a leading role on downstream process development; scale up, and technical support of cGMP manufacturing for proteins, nanoparticles and virus-like particle (VLP) based vaccines. The candidate will ensure scientifically sound design and scalable purification processes are created. The candidate will also be responsible for generating materials for pre-clinical studies and other development purposes. The candidate is expected to be highly self-motivated, well organized and very productive.
This position will be located at our Gaithersburg, MD facility and will report to the Manager of Downstream Process Development.
Responsibilities include but are not limited to:
Support the development of a new purification process, by reviewing and compiling relevant literature data to include structure, physico-chemical, and biological data on the target protein, to propose the most suitable purification process train of steps based on these data. Optimize the proposed process to demonstrate it is robust, high purity/yield, economic and scalable for clinical stage manufacturing of nanoparticle vaccine and other biologic product candidates, with particular attention to regulatory expectations on product quality and also on suitability and sourcing of raw materials, reagents, and separation materials. Ensure unit operations are feasible to implement at the intended manufacturing scale. Design experimental work independently or with minimal supervision. Ability to process complex data and communicate clearly and timely the implications of the results. Perform and analyze Design of Experiment (DOE) studies to develop or optimizing downstream processes to ensure a phase-appropriate, consistent, high-yielding with high-purity, and scalable. Generate, manage, evaluate, and maintain critical data in a highly organized manner. Provide reports for assessment by senior management. Assist in scale up and optimization of early stage processes, support critical operations as needed in our GMP manufacturing facility and deliver materials for pre-clinical and clinical studies. Provide reagents and other supplies for various projects and departments. Collaborate and coordinate with colleagues from Discovery, Process Development, Analytical Development, Manufacturing, and QA/QC teams. Support process characterization studies and tech transfer process. As needed, support process validation, including validation protocol writing, execution and report writing. Support viral clearance studies, including review of protocols, execution of studies, and report writing. This position is expected to be mainly hands on in the laboratory.
gmp, Downstream, Purification, Biologics, vaccine, DOE, Filtration, chromatography, TFF, Cell Biology
Top Skills Details:
Support the development of a new purification process
Optimize the proposed process to demonstrate it is robust, high purity/yield, economic and scalable for clinical stage manufacturing of nanoparticle vaccine and other biologic product candidates
Additional Skills & Qualifications:
PhD in relevant scientific discipline with 0-3+ years of industry experience; may include post-doctoral experience MS in relevant scientific discipline with 3-5+ years of directly relevant experience BS in relevant scientific discipline with 7-10+ years of directly relevant experience Hands-on downstream purification experience is required.
Knowledge in purification of vaccines/biologics; Experience in various chromatography methods, filtration, and TFF unit operations. Direct experience with virus-derived recombinant products and/or viral particles is a plus. Capable of performing multiple functions in a fast-paced environment. Strong technical protocol/report writing and good organization skills are required. Diverse knowledge and experience in various relevant areas, including but not limited to molecular/cell biology, harvest, formulation and common analytical tools is preferred. Excellent record keeping abilities to adequately record, analyze and document data generated in support of regulatory requirements. Demonstrated verbal and written skills in communicating scientific and technical information. Knowledge of FDA regulatory requirements associated with analytical characterization and documentation of vaccine products. Proficient in Window based software including Excel, PowerPoint and Word.
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The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.