Summary: The Process Development Associate Scientist is part of Cleaning Characterization group based in Client’s Thousand Oaks, CA corporate headquarters, who are responsible for the development of cleaning process design supporting new product introduction in internal and external manufacturing network for both drug substance and drug product. The cleaning characterization group develops new processes including chemistries, temperature and contact time that support the implementation of cleaning validation studies within manufacturing sites. The group supports investigation of deviations/non conformances, writes technical cleaning evaluation reports, and supports plant inspections, including PAIs.
Responsibilities:
Design and perform planned experiments for developing large-scale processes
Help develop new methods, apparatus and procedures for bench-scale characterization work and scale-up
Write technical reports, assessments, and procedures
Use characterization data to develop key operating parameters (KOPs), testing requirements and acceptance criteria for new product launches
Work with Quality, Engineering and Process Development to implement Validation requirements at full scale
Help write technical papers for internal and external publication
Basic Qualifications:
Master’s degree and 2 years of Scientific experience OR
Bachelor’s degree and 4 years of Scientific experience
Preferred Qualifications:
Design and execution of bench-scale experiments
Analytical methods: Total Organic Carbon (TOC), protein assays, gel electrophoresis, spectroscopic methods
Characterization and validation of processes for biologicals
Good knowledge of scientific principles, methodologies and practices
Lab methods, including handling and dispensing chemicals, preparing buffers and operation of common lab equipment, such as pH and conductivity meters
Strong interpersonal skills
Good written and verbal communication skills
Top 3 Must Have Skill Sets:
Prior laboratory experience of handling instruments
Designing experiments
Technical report writing
Pay Transparency: The typical base pay for this role across the U.S. is: $24.50 - $25.50/hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
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Numbers & Facts
Location
Thousand Oaks, CA
Salary
$24.50–$25.50 Per Hour
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Skills
Analysis Skillsunmatched
Artificial Intelligence (AI)unmatched
Assaysunmatched
Automotive Automationunmatched
Biological Processesunmatched
Communication Skillsunmatched
Consultingunmatched
Drug Productsunmatched
Experiment Designunmatched
Interpersonal Skillsunmatched
Laboratoryunmatched
Laboratory Equipmentunmatched
Laboratory Operationsunmatched
Manufacturingunmatched
Messaging Technologyunmatched
Presentation/Verbal Skillsunmatched
Process Developmentunmatched
Product Designunmatched
Product Supportunmatched
Product/Service Launchunmatched
Publicationsunmatched
Purchasing/Procurementunmatched
Quality Engineeringunmatched
Reporting Skillsunmatched
Requirements Validation/Verificationunmatched
Scientific Principlesunmatched
Short Messaging Service (SMS)unmatched
Speech Technologyunmatched
State Laws and Regulationsunmatched
Technical Writingunmatched
Telephonyunmatched
Test Requirementsunmatched
Writing Skillsunmatched
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