Clinical-Scientific Quality Control Chemist
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Job Location:
Bothell, WA - USA
Monthly Salary:
Not Disclosed
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
Position Details:
Our client a world-leading Pharmaceutical Company in Bothell WA is currently looking for a QC Chemist IV to join their expanding team.
Job Title: QC Chemist IV (Method Tranfer Method Validation) / Pharma Industry
Duration: 12 months contract extendable up to 48 months
Location: Bothell WA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Quality Control Chemist
Role Summary:
This position serves as a quality control expert within the Quality Control Sciences and Validation group providing critical support for analytical method transfer and validation activities across global pharmaceutical operations.
The role requires an individual contributor who can independently manage complex technical projects while ensuring compliance with current Good Manufacturing Practices and regulatory standards.
This scientist will serve as a technical authority for method transfer initiatives working across multiple internal and external testing sites to support drug development programs.
The position demands strong analytical expertise combined with excellent project management capabilities to coordinate deliverables and maintain timelines.
Success in this role requires the ability to balance multiple priorities while maintaining rigorous attention to detail and scientific integrity throughout all validation and transfer activities.
This position serves as a quality control expert within the Quality Control Sciences and Validation group providing critical support for analytical method transfer and validation activities across global pharmaceutical operations.
The role requires an individual contributor who can independently manage complex technical projects while ensuring compliance with current Good Manufacturing Practices and regulatory standards.
This scientist will serve as a technical authority for method transfer initiatives working across multiple internal and external testing sites to support drug development programs.
The position demands strong analytical expertise combined with excellent project management capabilities to coordinate deliverables and maintain timelines.
Success in this role requires the ability to balance multiple priorities while maintaining rigorous attention to detail and scientific integrity throughout all validation and transfer activities.
Responsibilities:
Support Project Leads for method transfer and validation activities internally and externally for assigned pharmaceutical development programs
Author and review protocols and reports for method transfer method validation method bridging and other technical development documentation associated with analytical methods
Plan and track method transfer and validation deliverables to ensure timely completion of project milestones
Collaborate and interact with internal global quality control testing sites and laboratories external testing sites project leads and functional representatives
Review method transfer and validation assays perform data verification conduct non-routine data mining and execute in-depth data analysis
Represent quality control in intra-department projects and initiatives or cross-functional teams in support of program and company goals
Support Project Leads for method transfer and validation activities internally and externally for assigned pharmaceutical development programs
Author and review protocols and reports for method transfer method validation method bridging and other technical development documentation associated with analytical methods
Plan and track method transfer and validation deliverables to ensure timely completion of project milestones
Collaborate and interact with internal global quality control testing sites and laboratories external testing sites project leads and functional representatives
Review method transfer and validation assays perform data verification conduct non-routine data mining and execute in-depth data analysis
Represent quality control in intra-department projects and initiatives or cross-functional teams in support of program and company goals
Skills:
Expertise in designing and evaluating method validation and transfer studies including partial re-validation co-validation and cross-validation approaches
Technical writing skills for authoring analytical methods validation protocols and transfer study reports
Expert knowledge of scientific principles and expertise with monoclonal antibodies antibody-drug conjugates vaccines and gene therapy products
Strong analytical mindset and technical skills in analytical methods and plate-based methods with preference for analytical separation method experience including size exclusion chromatography imaged capillary isoelectric focusing and capillary electrophoresis sodium dodecyl sulfate
Project management skills with demonstrated experience managing multiple projects simultaneously
Strong data interpretation method troubleshooting skills and sound scientific judgment
Excellent time management skills with attention to detail and commitment to achieving team and individual goals
Strong communication skills to lead teams and influence leaders or cross-functional team members
Understanding of regulatory guidance and requirements pertaining to method transfer method validation and regulatory submissions
Expertise in designing and evaluating method validation and transfer studies including partial re-validation co-validation and cross-validation approaches
Technical writing skills for authoring analytical methods validation protocols and transfer study reports
Expert knowledge of scientific principles and expertise with monoclonal antibodies antibody-drug conjugates vaccines and gene therapy products
Strong analytical mindset and technical skills in analytical methods and plate-based methods with preference for analytical separation method experience including size exclusion chromatography imaged capillary isoelectric focusing and capillary electrophoresis sodium dodecyl sulfate
Project management skills with demonstrated experience managing multiple projects simultaneously
Strong data interpretation method troubleshooting skills and sound scientific judgment
Excellent time management skills with attention to detail and commitment to achieving team and individual goals
Strong communication skills to lead teams and influence leaders or cross-functional team members
Understanding of regulatory guidance and requirements pertaining to method transfer method validation and regulatory submissions
Experience:
8-10 years of relevant experience in pharmaceutical or biological drug product development analytical chemistry or quality control within a regulated biotechnology or pharmaceutical company
Progressive levels of responsibility throughout career demonstrating increasing technical and leadership capabilities
8-10 years of relevant experience in pharmaceutical or biological drug product development analytical chemistry or quality control within a regulated biotechnology or pharmaceutical company
Progressive levels of responsibility throughout career demonstrating increasing technical and leadership capabilities
Qualifications:
Bachelors degree in analytical chemistry biology biochemistry pharmaceutical science or related technical discipline in life sciences
Post-graduate degree in a related field is preferred
Bachelors degree in analytical chemistry biology biochemistry pharmaceutical science or related technical discipline in life sciences
Post-graduate degree in a related field is preferred
This is an exceptional opportunity to join a leading pharmaceutical organization where you will play a pivotal role in ensuring the quality and regulatory compliance of critical analytical methods that support life-saving therapies.
You will work at the intersection of science and quality collaborating with talented professionals across global sites while contributing to innovative drug development programs that make a real difference in patients lives.
You will work at the intersection of science and quality collaborating with talented professionals across global sites while contributing to innovative drug development programs that make a real difference in patients lives.
Key Skills
- Computer
- IT Audit
- Catering
- Fire And Safety Engineering
- Front Office Management
