Quality Control Chemist - IV
Description:
Title: Quality Control Chemist - IV
Location: Remote, Bothell WA, 98021
Job Duration: 12 months Contract
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. 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. 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.
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 (Client 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).
• 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 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.
Role Experience Requirements -
• A total of 8+ years of relevant experience is required.
• Minimum 3 years in Quality Control (QC) is mandatory.
• Experience can be combined across QC and other related groups.
• Candidates currently pursuing a PhD (without degree completion) will not be considered.
• Candidates with 15+ years of experience are not considered overqualified.
Technical Expertise (Must-Have) -
The manager emphasized that resumes must clearly demonstrate:
• Strong experience with:
o SEC (Size Exclusion Chromatography)
o ICIEF (Imaged Capillary Isoelectric Focusing)
o CES (Capillary Electrophoresis–SDS)
o DS (Dissolution Studies or relevant separation techniques as discussed)
• Direct experience with:
o Monoclonal antibodies (mAbs)
o Antibody-drug conjugates (ADCs)
• Late-stage commercial product experience (not early clinical).
• Method transfer and validation experience, specifically:
o Late-stage transfer and validation (not transfer alone).
o Around 3+ years of direct method transfer/validation experience.
o Managing 3–5 concurrent method transfers/validations.
• Strong expertise in separation techniques (deep analytical understanding required).
• GMP and QC experience clearly listed on the resume.
Important but Not Mandatory -
• Regulatory exposure is a plus but not required.
• ELISA and other plate-based methods (e.g., QPCR) are beneficial but not a key focus.
• Additional analytical techniques beyond the core required ones are good to have but not essential.
Writing & Documentation Expectations -
• Candidates must have experience in:
o Drafting documents.
o Writing validation protocols/reports.
• Purely routine QC testing analysts without documentation experience are not preferred.
• Strong writing experience combined with analytical expertise is highly valued.
Profile Gaps Observed in Submitted Resumes -
The manager noted common issues:
• Candidates focused only on:
o Plate-based assays (e.g., ELISA), OR
o Routine QC testing without method development/validation.
• Lack of combined experience in:
o mAbs/ADCs,
o Separation techniques,
o Method transfer + validation,
o GMP/QC.
• Protein purification experience without deep analytical/separation expertise is insufficient.
Work Location & Schedule -
• Role location: Washington (Pacific Time Zone).
• Local candidates: Hybrid schedule (50% onsite, ~2.5 days/week).
• Out-of-state candidates: Fully remote allowed.
• Time zone:
o Pacific preferred.
o Eastern acceptable (not a deal breaker).
• Local candidates preferred overall, but strong remote candidates will be considered.
Must-Haves on Resumes -
Candidates must clearly demonstrate:
• Late-stage method transfer & validation.
• mAb/antibody experience (ADC preferred).
• QC/GMP experience.
• Strong separation technique expertise.
• Experience managing multiple concurrent validations.
• Documentation/writing experience.
Apply Now
Apply Now
Title: Quality Control Chemist - IV
Location: Remote, Bothell WA, 98021
Job Duration: 12 months Contract
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. 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. 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.
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 (Client 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).
• 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 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.
Role Experience Requirements -
• A total of 8+ years of relevant experience is required.
• Minimum 3 years in Quality Control (QC) is mandatory.
• Experience can be combined across QC and other related groups.
• Candidates currently pursuing a PhD (without degree completion) will not be considered.
• Candidates with 15+ years of experience are not considered overqualified.
Technical Expertise (Must-Have) -
The manager emphasized that resumes must clearly demonstrate:
• Strong experience with:
o SEC (Size Exclusion Chromatography)
o ICIEF (Imaged Capillary Isoelectric Focusing)
o CES (Capillary Electrophoresis–SDS)
o DS (Dissolution Studies or relevant separation techniques as discussed)
• Direct experience with:
o Monoclonal antibodies (mAbs)
o Antibody-drug conjugates (ADCs)
• Late-stage commercial product experience (not early clinical).
• Method transfer and validation experience, specifically:
o Late-stage transfer and validation (not transfer alone).
o Around 3+ years of direct method transfer/validation experience.
o Managing 3–5 concurrent method transfers/validations.
• Strong expertise in separation techniques (deep analytical understanding required).
• GMP and QC experience clearly listed on the resume.
Important but Not Mandatory -
• Regulatory exposure is a plus but not required.
• ELISA and other plate-based methods (e.g., QPCR) are beneficial but not a key focus.
• Additional analytical techniques beyond the core required ones are good to have but not essential.
Writing & Documentation Expectations -
• Candidates must have experience in:
o Drafting documents.
o Writing validation protocols/reports.
• Purely routine QC testing analysts without documentation experience are not preferred.
• Strong writing experience combined with analytical expertise is highly valued.
Profile Gaps Observed in Submitted Resumes -
The manager noted common issues:
• Candidates focused only on:
o Plate-based assays (e.g., ELISA), OR
o Routine QC testing without method development/validation.
• Lack of combined experience in:
o mAbs/ADCs,
o Separation techniques,
o Method transfer + validation,
o GMP/QC.
• Protein purification experience without deep analytical/separation expertise is insufficient.
Work Location & Schedule -
• Role location: Washington (Pacific Time Zone).
• Local candidates: Hybrid schedule (50% onsite, ~2.5 days/week).
• Out-of-state candidates: Fully remote allowed.
• Time zone:
o Pacific preferred.
o Eastern acceptable (not a deal breaker).
• Local candidates preferred overall, but strong remote candidates will be considered.
Must-Haves on Resumes -
Candidates must clearly demonstrate:
• Late-stage method transfer & validation.
• mAb/antibody experience (ADC preferred).
• QC/GMP experience.
• Strong separation technique expertise.
• Experience managing multiple concurrent validations.
• Documentation/writing experience.
Apply Now
Apply Now