Method Transfer Lead Scientist - Pioneer Data Systems
Bothell, WA 98021
About the Job
Position Details:
Our client, a world-leading Pharmaceutical Company in Bothell, WA is currently looking for a Method Transfer Lead Scientist to join their expanding team.
Job Title: Method Transfer Lead Scientist / Biologics / REMOTE WORK
Duration: 18 months contract, extendable up to 36 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:
Candidates local to Bothell, WA who can come onsite for a hybrid schedule are preferred, however, remote candidates will also be accepted
Method Transfer Lead Scientist
Summary:
The Method Transfer Lead (MTL) Scientist, is a QC expert within the Development QC 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.
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 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
Qualifications:
Bachelor's degree in life science (Post-graduate degree in a related field is a plus) in biology, biochemistry or any related technical discipline
A minimum of 8+ 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
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 the design of study/experiment
Have a good mindset and technical skills in analytical methods and plate-based method
Candidates with binding ELISA, cytotoxicity, resProA, res DNA, and host cell protein method experiences 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 sound 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
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, etc.
Location:
Candidates local to Bothell, WA who can come onsite for a hybrid schedule are preferred, however, remote candidates will also be accepted
Our client, a world-leading Pharmaceutical Company in Bothell, WA is currently looking for a Method Transfer Lead Scientist to join their expanding team.
Job Title: Method Transfer Lead Scientist / Biologics / REMOTE WORK
Duration: 18 months contract, extendable up to 36 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:
Candidates local to Bothell, WA who can come onsite for a hybrid schedule are preferred, however, remote candidates will also be accepted
Method Transfer Lead Scientist
Summary:
The Method Transfer Lead (MTL) Scientist, is a QC expert within the Development QC 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.
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 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
Qualifications:
Bachelor's degree in life science (Post-graduate degree in a related field is a plus) in biology, biochemistry or any related technical discipline
A minimum of 8+ 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
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 the design of study/experiment
Have a good mindset and technical skills in analytical methods and plate-based method
Candidates with binding ELISA, cytotoxicity, resProA, res DNA, and host cell protein method experiences 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 sound 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
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, etc.
Location:
Candidates local to Bothell, WA who can come onsite for a hybrid schedule are preferred, however, remote candidates will also be accepted
Source : Pioneer Data Systems