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Skills
Analysis Skillsunmatched
Bacteriaunmatched
Biotech and Pharmaceuticalunmatched
Communication Skillsunmatched
Cross-Functionalunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Data Setsunmatched
Documentationunmatched
Drug Developmentunmatched
FDA Requirementsunmatched
Feasibility Analysisunmatched
Identify Issuesunmatched
Laboratoryunmatched
Leadershipunmatched
Manufacturingunmatched
Manufacturing/Industrial Processesunmatched
Microbiologyunmatched
Presentation/Verbal Skillsunmatched
Process Developmentunmatched
Process Manufacturingunmatched
Product Lifecycleunmatched
Quality Controlunmatched
Regulationsunmatched
Root Cause Analysisunmatched
Technical Supportunmatched
Test Labunmatched
Testingunmatched
Time Managementunmatched
Writing Skillsunmatched
Description
Duration: 6-month contract
Shift: Dayshift 8 - 5 PM Hybrid set up: All candidates must be willing to work 5 days onsite when needed but can also be a remote depending on the schedule or agreement with the hiring manager.
Job Description:
Scientist will support microbiology related methods such as, endotoxin, bioburden, sterility and other compendial methods associated with microbial control.
Hands on laboratory work include method troubleshooting, and involvement in evaluating new technologies related to rapid microbiology methods, including developing and executing feasibility and/or validation studies.
The candidate will require to work in the laboratory to support feasibility and/or validation studies (time spent in lab varies depending on projects).
Experience in pharmaceutical/biotechnology microbiology and manufacturing are preferred.
The candidate would be a part of a team that supports various microbiology methods in various stages of the product life cycle.
This team supports programs/methods at locations throughout the company.
The Scientist collaborates with representatives from key functions within Process Development, Manufacturing, and Quality.
Ideal candidate: Candidates that have industry experience in biopharmaceutical manufacturing.
Day to day responsibilities:
Candidate will work on validations/studies to support QC labs as needed (e.g., rapid micro methods, LER troubleshooting).
Help develop/execute sterile filter validations internally.
Attend meetings with QC.
Assist in reviewing regulation and pharmacopeia changes and determine overall impact, as well as protocols/summary reports executed by contract testing labs.
Provide micro method technical support as needed.
Basic Qualifications:
Doctorate Degree OR
Master’s Degree and 4 years of Scientific Experience OR
Bachelor’s degree and 6 years of Scientific experience
Preferred Qualifications:
Prior experience in Microbiological Quality at the technical level, including experience with sterile filtration validations
Advanced understanding and hands-on experience in various analytical platform such as compendial microbial methods, rapid methods for microbial detection/identification and advanced technologies for detection of bacteria
Excellent written and oral communication skills for the timely documentation, presentation and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment.
Advanced ability to critically analyze and interrogate various analytical data sets (e.g. complex dilution schemes) to drive and influence the investigational process
Advanced root cause analysis capabilities including leading advanced and complex events
Advanced ability to propose and lead new scientific imperatives/initiatives
Expert in an investigational laboratory setting within a pharmaceutical or biotechnology company
Advanced experience in working closely with scientific and manufacturing disciplines across process development, clinical, and commercial operations
Familiarity with cGMP regulations, FDA and EU regulations and guidelines
Top must have skills:
Experience in QC Microbiology Lab.
Knowledgeable on regulations (FDA CFRs, EMA Annex 1, Pharmacopeias).
Experience in troubleshooting methods (endotoxin/LER) and sterile filter validation.
About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"
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