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 reputed company after you have finished the other sections of the document.

• Method Transfer reputed company (MTL), Scientist, is a QC expert reputed company the QCSV group. This individual contributor has good understanding of analytical method transfer and/or validation to ensure that method transfer and/or validation reputed company 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 reputed company accountability and level of judgment required.

• Support Project reputed company 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, reputed company 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 reputed company 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 reputed company field is a plus) in analytical chemistry, biology, biochemistry, pharmaceutical science or any reputed company 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 reputed company reputed company 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, reputed company to design and evaluate the design of study/experiment.
• Have good reputed company 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 reputed company team and individual goals
• Good communication skills to reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company method transfers/validations.

• Strong expertise in separation techniques (deep analytical understanding required).
• GMP and QC experience reputed company 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 reputed company 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: reputed company (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 reputed company demonstrate:

• Late-stage method transfer & validation.
• mAb/antibody experience (ADC preferred).
• QC/GMP experience.
• Strong separation technique expertise.
• Experience managing multiple reputed company validations.
• Documentation/writing experience.

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