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Job Requirements of Quality Control Chemist - IV:
-
Employment Type:
Contractor
-
Location:
Bothell, WA (Onsite)
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Quality Control Chemist - IV
Careers Integrated Resources Inc
Bothell, WA (Onsite)
Contractor
Job Title: Quality Control Chemist - IV
Location: Bothell, WA 98021
Duration: 12 months+ (Possible Extension)
Pay range: $45 - $53.98/hr. on W2
Shift: 8 AM to 5 PM
Position Summary:
Position Responsibilities:
Organizational Relationships:
Education and Experience:
Technical Skills Requirements:
Location: Bothell, WA 98021
Duration: 12 months+ (Possible Extension)
Pay range: $45 - $53.98/hr. on W2
Shift: 8 AM to 5 PM
Position Summary:
- Method Transfer Lead (MTL), Scientist, is a QC expert within the QCSV group.
- This individual contributor has good understanding of analytical method transfer and/or validation to ensure that method transfer and/or validation comply with cGMP and regulatory expectations.
- Supports internal and external method transfer and validation activities for assigned programs.
- Collaborates with cross-functional teams to meet program goals.
- Analyzes and interprets complex data to ensure high-quality deliverables.
- Provides technical guidance and representation of QC in intra-department and cross-functional initiatives.
Position Responsibilities:
- Support Project Lead for method transfer and/or validation internally and externally for assigned program(s).
- Author or review protocols and reports for method transfer, method validation, method bridging, and other technical development reports associated with methods.
- Plan and track method transfer and/or method validation deliverables.
- Collaborate and interact with internal global QC testing sites/labs and external testing sites/labs, project leads, and functional representatives.
- Review method transfer and/or method validation assays, perform data verification, non-routine data mining, and in-depth data analysis.
- Represent QC in intra-department project/initiative or cross-functional teams in support of program and company goals.
Organizational Relationships:
- QCSV-Portfolio
- PGS (*** Global Supply)
- Analytical R&D
Education and Experience:
- Bachelor’s degree in life science (Post-graduate degree in a related field is a plus) in analytical chemistry, biology, biochemistry, pharmaceutical science, or any related technical discipline.
- 8-10 years of relevant experience in pharmaceutical/biological drug product development, analytical chemistry, and/or QC in a regulated biotechnology or pharmaceutical company with progressive levels of responsibility.
Technical Skills Requirements:
- Expertise in designing and evaluating method validation and transfer studies, including approaches such as partial re-validation, co-validation, and cross-validation.
- Technical writing skills for authoring methods, validation, and transfer studies/protocols/reports.
- Expert knowledge of scientific principles and expertise of mAb, Client, vaccine, gene therapy; able to design and evaluate study/experiment design.
- Good mindset and technical skills in analytical methods and plate-based methods; experience with analytical separation methods (SEC, icIEF, CE-SDS) preferred but not required.
- Good project management skills and experience managing multiple projects simultaneously.
- Strong data interpretation, method troubleshooting skills, and sound scientific judgment.
- Good time management skills with attention to detail and desire to achieve team and individual goals.
- Good communication skills to lead a team and influence other leaders or cross-functional team members.
- Understanding of regulatory guidance and requirements (ICH, CFR, general guidance) pertaining to method transfer and method validation, regulatory submissions such as IND, IMPD, BLA, or NDA.
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