job summary: Client is seeking an Analytical Sciences & Technology (AS&T) CMC Manager. The Manager will provide leading support for analytical method-related activities supporting late-phase development and commercial programs. This role will serve as a key contributor across validation, transfer, gap assessment, and lifecycle management for analytical methods across internal and external testing networks. The ideal candidate will bring expertise in analytical sciences, late-stage CMC development and regulatory expectations, with a demonstrated ability to lead method readiness and execution activities in support of product development, filings, and commercial supply. location: Norwood, Massachusetts job type: Contract salary: $70 - 81 per hour work hours: 9 to 5 education: Bachelors responsibilities: Lead and support analytical method-related strategies for late-phase and commercial programs, ensuring alignment with regulatory expectations, phase-appropriate requirements, and overall program objectives.Lead analytical method gap assessments to evaluate readiness for late-phase development, regulatory submission, and commercial implementation. Identify technical, compliance, and documentation gaps; assess associated risks; and partner cross-functionally to define and drive plans for remediation and readiness.Lead and support analytical method transfer activities across internal laboratories and external testing partners, ensuring consistency, compliance, and operational readiness across the manufacturing and testing network.Author, review, and oversee validation-related documents, including validation master plans, protocols, reports, and associated technical documentation, to ensure alignment with program needs and regulatory requirements.Define and support lifecycle management strategies for commercial analytical methods, including governance, change control, method performance monitoring, and continuous improvement across the product lifecycle.Lead and contribute to the preparation and review of analytical documentation for regulatory filings supporting late-phase and commercial programs, ensuring technical rigor, consistency, and submission readiness.Support the preparation and execution of responses to regulatory queries and post-approval commitments by providing technical leadership, compiling data-driven justifications, and coordinating deliverables across functions.Serve as a analytical CMC partner across Analytical Development, Quality Control, Regulatory Affairs, Quality, Manufacturing, and Technical Operations to align method strategy, execution, and risk management across program milestones. qualifications: Qualifications Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field.8+ years of experience in Analytical Development, Quality Control, Analytical Sciences, or related functions within the biopharmaceutical industry.Strong expertise in analytical method qualification, validation, transfer, gap assessment, and lifecycle management in late-phase and commercial settings.Demonstrated experience supporting analytical documentation for regulatory submissions and health authority interactions for development and/or commercial programs.In-depth knowledge of ICH guidelines, GMP regulations, and industry best practices.Strong technical writing skills with the ability to author and review high-quality validation and regulatory documentation.Strong collaboration, communication, and influencing skills across cross-functional teams and external partners. Preferred Advanced degree (M.S. or Ph.D.) in a scientific discipline.Experience supporting biologics, vaccines, or other complex modalities.Experience leading analytical readiness activities for late-phase development, commercialization, or post-approval changes.Experience working across global manufacturing, testing, or external partner networks, including CDMOs and contract laboratories.Demonstrated ability to operate independently and drive complex technical workstreams in a fast-paced environment. #LI-LH1 skills: Good Manufacturing Practices (GMP), International Council for Harmonization (ICH), Chemistry Manufacturing and Controls (CMC) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make 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 addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all 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 continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.