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Notification Out From Somru Bioscience Careers Portal, Candidates Those Are Searching For Career Opportunities In Somru Bioscience, Can Apply For Jobs In Somru Bioscience For The Position Of R&D Biosimilar Manufacturing Manager. Read Out Full Job Description About This Somru Bioscience Recruitment Described Below. But Before You First Confirm That Your Profile Matches With Recruiters Defined Eligibility Criteria.
Somru Bioscience Jobs | R&D Biosimilar Manufacturing Manager Careers Opportunity In Charlottetown, Prince Edward Island
Somru Bioscience Opened Hiring On Their Official Careers Portal, Job Seekers Who Are Eligible And Interested To Work With Somru Bioscience As A R&D Biosimilar Manufacturing Manager, Now They Can Apply For Somru Bioscience Jobs. This Is Great Career Opportunity For Those Candidates Who Are Looking For A Employment Opportunity On Somru Bioscience Careers Portal. Candidates Need Experience From Relevant Field And Required Qualification. Selected Candidates Will Get A Pay Of Around $ 88,537.00 per year. Somru Bioscience Jobs In Charlottetown, Prince Edward Island.
Briefed Details Of Somru Bioscience Jobs For Position Of R&D Biosimilar Manufacturing Manager
Recruiting Agency / Department :- Somru Bioscience
Vacant Position :-NO JOBS AVAILABLE AT TIME
Jobs Type :- Somru Bioscience Jobs Canada
Salary :- $ 88,537.00 per year
Apply Through:- somrubioscience.com
Somru Bioscience Jobs In Prince Edward Island, Canada Full Job Description
Somru Bioscience Inc. is an emerging biotechnology company dedicated to developing breakthrough antibody technology for research, diagnostic and therapeutic applications. The company utilizes a unique and proprietary Somru™ technology which produces antibodies with superior binding affinity and bioactivity in a wide variety of biological assays in a short period of time. We also offer a wide range of quality reagents for research and diagnostics applications as well as for biosimilar research and development.
- Responsible for leading the research and development of bioprocesses for biosimilar production
- Provide functional leadership and subject matter expertise to establish phase-appropriate cell culture-based recombinant protein/antibody production processes
- Plan and execute experiments to evaluate downstream processing strategies and process conditions to produce high titer and product quality with high recovery rate in support of the expanding biosimilar pipeline
- Design and implement rigorous product development strategies utilizing Design of Experiment (DoE) and other process-design elements aligned with a Quality by Design (QbD) approach
- Facilitate process transfer, scale-up, validation and product/process comparability activities
- Proactively identify issues, provide general guidance to resolve CMC project issues, and develop solutions to meet productivity and quality milestones
- Deliver development reports and sections of regulatory submissions including comparability, similarity, and QbD risk assessments
- Work closely with the assay development team to guide efforts toward specification and method of analysis development.
- Provide hands-on and strategic leadership to a team of scientists and engineers to support company goals and activities
- Establish and achieve budget and timeline targets
- Support the technical team to validate and maintain equipment
- Develop and maintain productive relationships with internal and external collaborators and partners
- Responsible for multiple projects via cross-functional (matrix) management
- Work in collaboration with Operations group to execute protocols, experimental plans, critical production batches, and tech transfers.
- MS/PhD Biology, Biotechnology, Chemical Engineering or equivalent field
- PhD with 5+ years of experience.
- Knowledge of current GMPs, ISO, and FDA and / or European validation practices for biopharmaceutical processes
- Outstanding organizational and communication skills (especially technical writing, verbal and presentation), and excellent supervisory skills
- Demonstrated experience with process improvements, knowledge of manufacturing, and understanding of site operations, R&D, and production systems
- Demonstrated success with regulatory filings including BLA submissions and product launch is preferred
- Knowledge of SIMCA, DoE and other supportive soft wares a plus
- Willingness to work a flexible schedule including some nights and weekends
- Able to travel frequently
If you are interested in being considered for this position:
Email resume to: [email protected]
Somru BioScience Inc.
19 Innovation Way
Charlottetown, PE, C1E 0B7
TEL: 902-367-4322 | Fax: 902-367-4323
E-MAIL: [email protected]