Senior Scientist, Downstream Process Development

ClinicalPro is seeking a Senior Scientist, Downstream Process Development for a leading organisation located in the USA.

This individual will be responsible for leading the pre-formulation investigations for natural and recombinant proteins.

Must be eligible to work in the USA.

Developing and carrying out every step of the pre-formulation and protein purification process.
High-throughput screening, process development, process and protein characterisation.
Process scale-up/down, and technical assistance for cGMP manufacturing, quality control, and regulatory operations.
To specify process-compatible buffer conditions, excipients, and protein stability at crucial stages of the protein purification process.
Build pre-formulation capabilities and high-throughput pre-formulation workflows.
Collaborate closely with members of the analytical development, downstream, and upstream groups.
Foster a cooperative atmosphere that will promote reliable manufacturing processes.
Provide direction to pilot- and commercial-scale production groups through rigorous and well-documented studies.
In-depth expertise in protein characterization and purification.
Practical knowledge of chromatography, ultrafiltration, and diafiltration.
Knowledge in process optimisation, scale-up, and scale-down techniques.
Have a thorough understanding of methods for biophysical characterization and pre-formulation development.
Writing research papers, and presenting findings in a multidisciplinary team setting are all required of the successful applicant.
Meetings with the cross-functional project team, the incumbent will represent the department.
Have the motivation and capacity to work as a vital member of a team and help drug development teams.

Skills and Requirements

Ph.D. level degree, ideally in protein chemistry, biophysics, or biological sciences.
0-4+ years of experience.
M.S. with 8+ years of relevant research or industry experience, or a B.S. with 10+ years of relevant research or industrial experience.
Experience with biochemical and biophysical methods, process and protein characterisation, statistical experiment design, and data analysis.
Proficient in computer operations, purifying machinery (such AKTA systems), and a basic knowledge of GMP guidelines.
Experience in creating unique manufacturing technologies.

If you’re interested in this position, apply now to send us an updated copy of your CV, or give us a call right away.

To explore more opportunities, visit Opportunities at ClinicalPro