Mission
Biotechnology
DevelopmentScientistIII,AnalyticalDevelopmentandClinicalQualityControl
“Development Scientist III, Analytical Development and Clinical Quality Control at Mission. Skills: Bioassay development, Impurity methods, Analytical method development, Method qualification. Develop bioassay methods. Optimize bioassay methods”
Industry & Context.
Problem solving; Troubleshooting; Investigations
Ability to travel up to 20%, Lab environment, Lift/carry 15/30 pounds, Work with biological, infectious, and hazardous materials, Gown/de-gown use, Engage in communications via phone, video, and electronic, Maintain general availability during standard business hours
What They're Looking For.
Must Have
Ph. D. or master’s degree, 6+ years analytical method development, Experience with method development, optimization, qualification, validation, transfer, and investigation for biotherapeutics, Familiar with cGMP, ICH, USP and WHO guidelines, Scientific skills in biochemistry, molecular and cellular biology, Ability to take initiative in problem solving, Ability to independently contribute and oversee the generation of procedures, protocol and reports
Nice to Have
Experience in microbiology assays, Technical lead skills, People managing skills, Knowledge of other technical areas within ADQC/PDCS organization
What You'll Do.
Develop bioassay methods
Optimize bioassay methods
Qualify bioassay methods
Evaluate biological activities
Evaluate biochemical activities
Evaluate cellular activities
Qualify impurity methods
Develop impurity work strategy
Author method development reports
Author method qualification reports
Author responses to health authority queries
Lead problem-solving efforts
Present scientific/technical information
Assist with prioritizing technical work
Achieve milestone deliverables
Explore innovative technologies
Improve bioassay throughput
Improve impurity method throughput
Improve bioassay efficiency
Improve impurity method efficiency
Establish continuous improvement systems
Incorporate improvements into business
How You'll Work.
Team & Collaboration
Interact with other functional areas; Cross-functional scientific/technical problem-solving; Cross-functional environment presentations
Communication Scope
Scientific presentations; Technical presentations
Process & Methodology
Prioritizing technical work, Meet project timelines, Achieve milestone deliverables, Multi-tasking
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