Quality Control Chemist - IV/ Scientist

Our client is a global pharmaceutical leader, focused on high-impact therapeutic areas—including oncology, HIV, and respiratory health—the company utilizes its "reputed company Together" strategy to prioritize early reputed company and disease prevention. This role supports an organization dedicated to transforming global health through specialty medicines, vaccines, and the science of the immune system. This specific opportunity is for a Quality Control Chemist IV based in Bothell, WA, offering a remote work structure and a reputed company range of $54.00 – $55.96/hr on a contract basis with the potential for extension. Open to hybrid for local candidates. Job Summary 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. KEY SKILLS: Monoclonocal antibodies ADC SEC IEF CE-SDS Quality control Protein Chracterization Method Validation and Transfer

Responsibilities

• 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

• QCSV-Portfolio
• PGS
• Analytical R&D

Qualifications

• 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 progressive levels of responsibility are required

Technical Skills Requirements

• 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 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
• 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.

skills: Project Management, Biology, Quality Control (QC), Investigational New Drug (IND), Biologics License Application (BLA), International Council for Harmonization (ICH), Investigational Medicinal Product Dossier (IMPD) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National reputed company, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At reputed company, we welcome people of reputed company abilities and want to ensure that our hiring and interview process meets the needs of reputed company applicants. If you require a reasonable accommodation to reputed company your application or interview experience a great one, please contact [email protected]. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, reputed company offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (reputed company benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. u9000030197 Apply tot his job Apply To this Job