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- Ensuring growth opportunities for our people
Senior Scientist, Downstream Process Development - Gaithersburg, United States - Actalent
Description
Seeking 1 Senior Scientist, Downstream Process Development
Onsite in Gaithersburg, MD
Description:
Qualified individuals will play a leading role in downstream process development and process characterization activities, new technology evaluation, and technical support of cGMP manufacturing for proteins, nanoparticles, and virus-like particle (VLP) based vaccines. The candidate will ensure scientifically sound experimental design, data analysis, and reporting. The candidate will be responsible for drafting technical development reports summarizing critical data. The candidate is expected to be highly self-motivated, well-organized, and an innovative thinker focused on execution with a sense of urgency. This position will report to the Executive Director, Downstream Process Development.
Responsibilities include but are not limited to:
Independently design, perform, and analyze results from studies to develop or optimize processes to ensure a phase-appropriate, consistent, high-yielding, and scalable downstream process.
Scale up and optimize early-stage processes and complete process characterization studies.
Advise scientists and research associates in the initiation and execution of laboratory experimentation, considering economic, regulatory, and safety factors.
Present results of work, interpret data and draw conclusions regarding presented material and nature of work.
Write technical reports utilizing sound scientific reasoning and interpretation of the available data. Generated documents will include process flow diagrams, process descriptions, and technical support studies.
Perform hands-on work in a downstream purification lab, specifically column chromatography and filtration operations for vaccine production, process development, process characterization, and scale-up.
Perform lab-scale experiments to identify root causes, support process changes, generate, and/or resolve manufacturing non-conformances.
Perform analytical assays, as needed.
Skills:
Downstream, Process development, Process Characterization, GMP, Proteins, VLP, Nanoparticles, Experimental Design, AKTA, Chromatography, UFDF, Tangential Flow Filtration, Statistical Design, statistical analysis, Viral Clearance, regulatory documentation
Additional Skills & Qualifications:
PhD in Bio/Chem Engineering, Biology, Chemistry, Pharmaceutical Science, Biochemistry, biophysics, Molecular Biology, Life Sciences, vaccine development, or a related scientific discipline with 5 plus years of experience, or MS degree with 7 plus years of experience in pharmaceutical or biotech companies.
Demonstrated technical proficiency, scientific creativity, collaboration with others, and independent thought in suggesting experimental design.
Experience Level:
Expert Level
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:
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.
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