Senior Scientist - Upstream Process Development
Proclinical is currently recruiting for a Sr. Scientist - Upstream Process Development with a pharmaceutical company located in Rockville, MD. A successful candidate will play a key role as a process development expert working on innovative recombinant protein-based antigen expression projects and platforms. The position will combine lab-based experimental work (60%-70% of time) and project coordination within a cross-functional group of CMC scientists working on high impact and visibility vaccine programs.
- Develop and improve Upstream processes for mammalian (primarily CHO) antigen expression projects from cell line development on to prepare for phase I development
- Perform hands-on bioreactor runs (mostly small-scale and high throughput)
- Support equipment maintenance and provide other laboratory systems oversight
- Facilitate process transfer to development units in charge of Phase I/II/III process development
- Interface with in-process analytical and analytical development to support robust early process and product characterization
- Support early project transition between discovery/pre-clinical and process development functions
- Streamline antigen development workflows related to clone selection, cell banking, process development and transfer
- Serve as a subject matter expert for Upstream process development
- Interface with Quality and Regulatory to support project documentation and CMC submissions
- Support new technology assessment and licensing activities
- Prioritize the deliverables from multiple programs and competing interests
- Train and mentor junior staff
Skills and Requirements:
- An advanced degree in biology, biochemistry, chemical engineering, bioinformatics or related biopharmaceutical process sciences
- PhD and 3+ years of industry experience or master's degree with 8+ years of industry experience
- Proven expertise & experience in Upstream mammalian cell culture process development
- Hands-on experience in working with small scale bioreactors (up to 50L) and(or) mini bioreactors
- Ability to plan, execute and perform data analysis using design of experiments and other advanced statistical approaches
- Ability to cross-train and collaborate with other process development functions such as in-process analytics and analytical development
- Preferred Qualifications include background in molecular biology, cell and gene therapy, mammalian cell line development experience, experience in media and feed optimization and metabolite analysis, prior experience in the vaccine development field, broad understanding of overall process development and analytical development activities required for CMC support
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Dominic Santoro at 215-531-5280 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.