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.