Sr. Scientist, Downstream

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.
• Collaborate and coordinate with colleagues from Discovery, Process Sciences, Upstream Development, Formulation Development, and Analytical Development teams.
• Train staff on new processes and technologies, as needed.

Minimum Requirements:

• 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.
• Demonstrated strong project management skills and ability to manage multiple projects simultaneously.
• A thorough understanding and working knowledge of the principles of purification and filtration processes is essential, with solid hands-on downstream process experience with chromatography systems, such as AKTA, and tangential flow (UFDF) filtration is required.
• Excellent record-keeping abilities to adequately record, analyze and document data generated in support of regulatory requirements are essential.
• Ability to think critically, and demonstrate troubleshooting and problem-solving skills.
• Excellent interpersonal, verbal, and written communication skills are essential.
• Self-motivated with a strong sense of ownership in areas of responsibility and willingness to accept temporary responsibilities outside of initial job description.
• Ability to work and collaborate in cross-functional teams (research, development, and manufacturing) in a fast-paced and dynamic team setting with a sense of urgency.
• High energy level and a positive outlook coupled with the requisite "can do" attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.

Preferred Qualifications:

• Practical demonstration of the use of statistical design of experiments and statistical analysis is a plus.
• Experience with viral clearance or drafting regulatory filing sections is a plus.