AS&T CMC Manager (Analytical Sciences & Technology)

The Fast Facts: Role: AS&T CMC Manager (Analytical Sciences & Technology) Location: Norwood, MA (100% Site-Based) Compensation: Up to $88.00/hour (Based on experience) Assignment Type: 6-Month Temporary Contract Target Start Date: July 13, 2026 Not open to C2C The Role Randstad, in partnership with our client, is seeking an Analytical Sciences & Technology (AS&T) CMC Manager to join a highly collaborative team at their state-of-the-art Norwood, MA site. In this role, you won't just be managing data—you will be a vital contributor to the heart of our late-phase development and commercial programs. You will serve as a key technical guide across validation, method transfer, gap assessments, and lifecycle management for analytical methods across internal and external testing networks. If you are passionate about late-stage CMC development and regulatory excellence, you will find a rewarding home here. Here’s What You’ll Do Strategize & Lead: Drive analytical method strategies for late-phase and commercial programs, ensuring everything aligns beautifully with regulatory expectations. Bridge the Gaps: Lead method gap assessments to evaluate readiness for regulatory submissions and commercial implementation, partnering cross-functionally to resolve technical or compliance gaps. Collaborate Globally: Lead method transfer activities across internal labs and external testing partners (CDMOs), ensuring consistency and compliance across the network. Own the Documentation: Author, review, and oversee critical validation master plans, protocols, and reports. Champion Lifecycle Management: Define strategies for method performance monitoring, change control, and continuous improvements across the product lifecycle. Be the Regulatory Partner: Help prepare and review analytical documentation for filings, and support data-driven responses to regulatory health authority queries. Connect the Dots: Act as the trusted analytical CMC partner across Analytical Development, QC, Regulatory Affairs, Quality, Manufacturing, and Tech Ops. Here’s What You’ll Need (Basic Qualifications) Education: Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field. Experience: 8+ years within the biopharmaceutical industry specifically focused on Analytical Development, Quality Control, or Analytical Sciences. Technical Expertise: Strong background in analytical method qualification, validation, transfer, and lifecycle management in late-phase or commercial settings. Regulatory Savvy: Solid experience supporting documentation for regulatory submissions and in-depth knowledge of ICH guidelines and GMP regulations. Communication Style: Top-tier technical writing skills balanced with strong collaboration and influencing skills—someone who genuinely enjoys working with cross-functional teams! Presence: This is a fully site-based position requiring your daily presence and energy at the Norwood, MA site (not eligible for remote work). Here’s What You’ll Bring to the Table (Preferred Qualifications) An advanced degree (M.S. or Ph.D.) in a scientific discipline. Experience supporting complex modalities like biologics or vaccines. A proven track record of leading analytical readiness for commercialization or post-approval changes. Experience working hand-in-hand with global manufacturing networks and CDMOs. Why You'll Love Working Here Our client believes that great science happens when people feel supported, included, and empowered. You will be joining a team of brilliant, down-to-earth professionals who work hard but always make room for collaboration and mutual respect. Ready to apply? 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 View email address on click.appcast.io. 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. #J-18808-Ljbffr Randstad USA