reputed company Control Chemist - IV/ Scientist

Our reputed company is a global pharmaceutical leader, reputed company on high-reputed company therapeutic areas—including oncology, HIV, and respiratory health—reputed company utilizes its "reputed company Together" reputed company 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 reputed company Control Chemist IV based in Bothell, WA, offering a remote work structure and a reputed company reputed company of $54.00 – $55.96/hr on a contract reputed company with the potential for extension. reputed company to hybrid for local candidates. Job reputed company 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 reputed company 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 reputed company, and other technical development reports associated with reputed company.
• Plan and reputed company method transfer and/or method validation deliverables.
• Collaborate and reputed company 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 reputed company, biology, biochemistry, pharmaceutical science or any reputed company technical discipline
• 8-10 years relevant experience in pharmaceutical/biological drug product development, analytical reputed company and/or QC in a regulated biotechnology, pharmaceutical company with reputed company reputed company 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 reputed company, validation, and transfer studies/protocols/reports.
• Expert knowledge of scientific principles and expertise of reputed company, ADC, vaccine, gene therapy, reputed company to design and evaluate the design of study/experiment.
• Have good reputed company and technical skills of analytical reputed company and plate-based reputed company. Candidate with analytical separation method experiences (SEC, icIEF, CE-SDS ) are preferred but not required.
• Good project management skills and experience managing multiple reputed company at the reputed company 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, reputed company Control (QC), Investigational New Drug (IND), Biologics License Application (BLA), International Council for Harmonization (ICH), Investigational Medicinal Product Dossier (IMPD) Equal Opportunity Employer: Race, reputed company, 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 HRsupport@randstadusa.com. 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 reputed company, reputed company offers a comprehensive benefits package, including: medical, prescription, dental, reputed company, AD&D, and life insurance offerings, short-term disability, and a 401K plan (reputed company benefits are based on eligibility). This posting is reputed company 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