Quality Control Chemist - IV

Position Summary

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.

• 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.

Primary interactions include internal global QC testing sites/labs, external testing sites/labs, project leads, and functional representatives.

• 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.

• 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, and ability to design and evaluate the design of study/experiment.
• 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.
• 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 submission such as IND, IMPD, BLA or NDA, etc.

• 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.

• Strong experience with:
  • SEC (Size Exclusion Chromatography)
  • ICIEF (Imaged Capillary Isoelectric Focusing)
  • CES (Capillary Electrophoresis–SDS)
  • DS (Dissolution Studies or relevant separation techniques as discussed)
• Direct experience with:
  • Monoclonal antibodies (mAbs)
• Late‑stage commercial product experience (not early clinical).
• Method transfer and validation experience, specifically:
  • Late‑stage transfer and validation (not transfer alone).
  • Around 3+ years of direct method transfer/validation experience.
  • 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.

• 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…