SR. STAFF SCIENTIST DOWNSTREAM PROCESS DEVELOPMENT
Our client is seeking a Sr. Staff Scientist Downstream Process
Development, the candidate will be accountable for planning,
development, optimization, execution and management of all assigned
client development tasks. Working with external clients, R&D,
Quality Control/ Quality Assurance and GMP Manufacturing, the Staff
Scientist Downstream Process Development will provide expertise and
scientific leadership for design, development, optimization, and
production of Protein Therapeutics and Viral Vectors. The
successful candidate will contribute to the team based execution of
projects, and will act as a primary lead with responsibility of
producing scalable and reproducible processes capable of GMP
Production. The candidate will design experiments to meet specific
criteria, support cGMP manufacturing operations, and provide
oversight for Technical Transfer, both internally and
The main responsibilities will include but not limited to
Develop robust, high-yield and scalable purification process
(recombinant protein and Virus like Particles) for Vaccine
Development and cGMP production of Phase I/II candidates.
Develop, optimize and scale-up protein purification methods to meet
cGMP and Regulatory Compliance using Design of Experiment (DOE)
Lead efforts to evaluate different resins, filters, and analytical
methods pertinent to purification development activities.
Perform experiments using AKTA series Chromatography skids, TFF
systems, and industry standard Harvest methods scale.
Interacts with other departments involved in GMP manufacturing for
planning production, testing and product release in a timely manner
resulting in successful completion of projects.
Participate in technology transfer of processes to Manufacturing
and from external clients, and from Process Development to
Generate, manage, and maintain critical data in a highly organized
manner in the form of notebook, protocol and SOP. Provide progress
and developmental reports for assessment by clients.
Develop and draft production batch records for GMP manufacturing,
support and troubleshooting GMP production activities.
Perform experiments and deliver results under minimal supervision,
and within tight time lines, to a prescribed budget for internal /
external client projects
Knowledge and Experience Required:
This position requires a PhD in a life science discipline
(Biochemistry, Analytical Chemistry Protein Chemistry or other
related discipline), with 10 years of experience in Vaccine
Development in Downstream Process Development, or an MS with 15
years experience, or a BS degree with 20years of experience.
Experience with cGMP Manufacturing under cGMP/cGLP compliance a
Experience with standard analytical techniques including
HPLC/SDS-PAGE, Bradford, BCA, and Endotoxin methods.
Intermediate computer skills using MS Office (Word, Excel, Power
Proven leadership skills.
Possess excellent interpersonal skills, both communications and
written. Must be able to communicate effectively with all echelons
of Management and staff.
Task & Team-oriented, analytical, organized, detail-oriented,
self-motivated & ability to multi-task.
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