Scientist, Upstream Process Development- Technical Development Drug Substance

Scientist, Upstream Process Development- Technical Development Drug Substance
+ Requisition ID:WD88494
+ Position:Full time
+ Open date:Sep 22, 2016 3:04 PM
+ Functional area:Science and Technology
+ Location:Maryland
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+ + Required degrees:Bachelors
+ Experience required:3 years
+ Relocation:Not Indicated
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Basic qualifications:? BS with 6+ or MS with 3+ years or PhD with 1+ years of experience
? Degree must be in a scientific discipline
? Hands-on and in-depth understanding of mammalian cell culture and cellular metabolism
? Hands-on experience with on-line and off-line analysis instruments associated with cell culture and viral vector production processes
? Basic experience with common bioanalytical assay execution
? Hands-on expertise in bioreactor system operation including AMBR, and wave and stirred tank bioreactors is essential
? Knowledge of industry trends and advancements is essential as well the ability to lead novel technology implementation
? Ability to plan and execute experiments and analyze resulting data using appropriate software
?Excellent verbal and written communication skills
Preferred qualifications:? Knowledge of equipment and procedures relating to upstream process development for the manufacture of vaccines. This includes a strong understanding of scale-up of bioreactors, multiphase mixing models, and mass transfer
?Additional hands-on experience and understanding of single use bioreactor (SUB) systems at pilot scale is desirable
? Knowledge of technology transfer to manufacturing plants is desirable
? Working knowledge of Quality by Design (QbD) and Design of Experiments (DoE) and statistical software such as Design Expert or JMP would be an advantage
? Good understanding of cGMP and manufacturing, and regulatory requirements for filing and registration of vaccine and/or biologics
? Ability to plan and execute experiments and to analyze and draw conclusions from resulting data
? Excellent verbal and written communication skills; and a demonstrated ability to work as part of a project team
Details:The employee is part of upstream process development team responsible for the development of early and late phase processes for the production of vaccines; performing cell culture development activities for recombinant vaccine antigens or viruses used for clinical and commercial development of vaccine candidate manufacturing processes; providing assistance in the execution of analytical methods in support of purification development for viral vaccines.
Major accountabilities include the followings:
? Performs upstream activities in support of viral vaccine development programs
? Must be able execute experiments independently
? Understanding of scale-up techniques and the ability to contribute to tech transfer to manufacturing will be essential
? Contributes to the transfer, evaluation and optimization of analytical assays used for in-process testing and characterization
? Contributes to regulatory filings and interactions with health authorities to ensure successful registration vaccine candidates
? Works on multiple projects internally, at other sites and at external manufacturers requiring initiative and judgment
? The qualified candidate must be able to effectively partner with diverse team members from various functions, multiple countries and members at various levels in organization
? Must be a self-starter, be able to work with minimal supervision in a matrix environment and effectively manage multiple projects
? Solves complex problems through analytical thinking to identify and understand alternatives using knowledge gained through formal education, experience and sound judgment
?Summarizes results in written reports and oral presentations
?Provides guidance and mentorship to less experienced colleagues and acts as a technical advisor
Contact information:
You may apply for this position online by selecting the Apply now button.
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