Full Job Description
Job Title
Scientist III, Downstream PD
Location
Rockville, MD 20850 US (Primary)
Job Type
Full-time
Funding available in current budget
115000
Exemption Type
Exempt
Career Level
Experienced (Non-Manager)
Education
Bachelor's Degree
Job Description
As a key technical contributor in the Downstream Process Development effort, the incumbent will play a leading role in the study execution. The incumbent will execute the downstream process screening, optimization, scale-up, characterization, and stability studies for proteins and viral vectors following protocol.
The incumbent in this position is expected to have extensive hands-on experience in downstream process development. This position involves developing scalable downstream purification processes for GMP production, optimizing process performance for yield and purity, and adapting existing procedures to meet regulatory requirements for the manufacture of protein and viral products intended for human injection. The successful candidate is expected to carry out the lab work with minimal supervision. This position is expected to interact with other departments involved in technology transfer, GMP manufacturing, product testing and quality assurance for product release.
ESSENTIAL JOB FUNCTIONS
• This is a hands-on laboratory role requiring active participation in experimental execution and process development activities.
• Perform downstream process screening, tangential flow filtration, nominal filtration, and chromatography for the purification of proteins and viral vectors.
• Generate, manage, and maintain critical data in a highly organized manner in the form of notebook, protocol and SOP.
• Assist technical reports, study summaries, and client-facing documentation.
• Responsible for laboratory maintenance, material ordering, inventory control, and preparation of experiments.
• Interact closely with other internal teams, including Upstream Process Development, Analytical Testing/Quality Control, Quality Assurance, and Manufacturing to support process transfer and product release timelines.
Job Requirements
• B.S. degree. in life science discipline with 4+ years of downstream process development experience.
• Highly proficient in chromatography, tangential flow filtration (TFF), and filtration.
• Experience in the development, purification, or characterization of viral vectors and/or protein-based biologics.
• Strong attention to detail with a track record of executing experimental work with a high level of accuracy and reliability. Exhibits neatness, accuracy, consistency and promptness in work habits.
• Ability to execute experimental work and deliver reliable results with minimal guidance, ensuring project milestones and timelines are met.
PREFERRED SKILLS & QUALIFICATIONS
• Experience with cGMP manufacturing under cGMP /cGLP compliance is a plus.
• Experience with standard analytical techniques including HPLC, SDS-PAGE, ELISA, and cell-based assays.
• Advanced computer and presentation skills using MS Office (Word, Excel, Power Point).
• Strong written and verbal communication skills with the ability to clearly communicate technical information across cross-functional teams.
• Task & Team-oriented, analytical, organized, detail-oriented, self-motivated & ability to multitask.
Travel Expectation
ADDITIONAL INFORMATION:
• Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen.
• Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements. Please note that "negotiable" is neither salary nor requirements. Salary commensurate with experience.