USA Quality Control Chemist IV
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Job Location:
Bothell, WA - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
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:
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:
Position Summary
Summarize the primary purpose & key accountabilities of the position including scope of responsibility in 5-7 concise sentences.
(It may be helpful to complete this section after you have finished the other sections of the document.
Method Transfer Lead (MTL) Scientist is a QC expert within the QCSV group.
Summarize the primary purpose & key accountabilities of the position including scope of responsibility in 5-7 concise sentences.
(It may be helpful to complete this section after you have finished the other sections of the document.
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.
Position Responsibilities
In order of importance list the primary responsibilities critical to the performance of the position.
In order of importance list the primary responsibilities critical to the performance of the position.
Please include actual tasks and/or essential responsibilities that highlight accountability and level of judgment required.
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 and/or method validation or 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 reps.
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.
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 and/or method validation or 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 reps.
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
Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.
QCSV-Portfolio
PGS (Pfizer Global Supply)
Analytical R&D
Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.
QCSV-Portfolio
PGS (Pfizer Global Supply)
Analytical R&D
Education And Experience
Indicate the formal education certification or license(s) required and/or preferred.
Include the minimum number of years of relevant experience required for the position (where legally permissible).
Bachelors 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 relevant experience in pharmaceutical/biological drug product development analytical chemistry and/or QC in a regulated biotechnology pharmaceutical company with progressive levels of responsibility are required
Indicate the formal education certification or license(s) required and/or preferred.
Include the minimum number of years of relevant experience required for the position (where legally permissible).
Bachelors 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 relevant experience in pharmaceutical/biological drug product development analytical chemistry and/or QC in a regulated biotechnology pharmaceutical company with progressive levels of responsibility are required
Technical Skills Requirements
Indicate the technical skills required and/or preferred as applicable.
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 ADC vaccine gene therapy able to design and evaluate the design of study/experiment.
Have good mindset and technical skills of analytical methods and plate-based methods. Candidate with analytical separation method experiences (SEC icIEF CE-SDS ) are preferred but not required.
Good project management skills and experience managing multiple projects at the same time is essential
Possess strong data interpretation method troubleshooting skills and sounds scientific judgement
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.
Understand of regulatory guidance and requirements (ICH CFR general guidance) pertaining to method transfer and method validation regulatory submission such as IND IMPD BLA or NDA etc.
Indicate the technical skills required and/or preferred as applicable.
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 ADC vaccine gene therapy able to design and evaluate the design of study/experiment.
Have good mindset and technical skills of analytical methods and plate-based methods. Candidate with analytical separation method experiences (SEC icIEF CE-SDS ) are preferred but not required.
Good project management skills and experience managing multiple projects at the same time is essential
Possess strong data interpretation method troubleshooting skills and sounds scientific judgement
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.
Understand of regulatory guidance and requirements (ICH CFR general guidance) pertaining to method transfer and method validation regulatory submission such as IND IMPD BLA or NDA etc.
Key Skills
- Computer
- IT Audit
- Catering
- Fire And Safety Engineering
- Front Office Management
