Job Details
Posted 24 June, 2026
Job Id: 627551
Senior Manager, Analytical Manufacturing Science and Technology (MSAT)
Job Description
enior Manager, Analytical MSAT (Small Molecule)
Location: United States (Remote)
Travel: Up to 50%
Level: Senior Manager
Overview
A leading, innovation-driven biopharmaceutical company is seeking a Senior Manager, Analytical Manufacturing Science & Technology (MSAT) to support commercial small molecule products within a fully outsourced manufacturing network.
This role serves as the primary analytical lead across contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs), ensuring analytical excellence, regulatory compliance, and reliable product release. The ideal candidate will bring strong technical expertise, experience managing external partners, and a proactive, problem-solving mindset.
Key Responsibilities
External Partner Analytical Oversight
- Serve as the primary day-to-day analytical lead for assigned commercial products at CMOs and CTLs
- Ensure execution of analytical testing (release, stability, in-process) aligns with cGMP requirements and internal quality standards
- Review and approve analytical data, test results, and laboratory documentation
- Provide support for critical manufacturing or quality events, including occasional off-hours engagement
Analytical Method Lifecycle & Technology Transfer
- Support method transfers, validations, and lifecycle management across external sites
- Coordinate transfer protocols, reports, and gap assessments with contract partners
- Monitor method performance across batches and sites; lead troubleshooting and continuous improvement efforts
Investigations & Deviation Management
- Lead or support investigations related to OOS, OOT, deviations, and laboratory errors
- Apply structured root cause analysis tools (e.g., 5 Whys, Fishbone) and Six Sigma methodologies
- Drive development and implementation of CAPAs, ensuring effectiveness and timely closure
Compliance & Documentation
- Ensure analytical operations meet global regulatory expectations (FDA, EMA, ICH guidelines)
- Maintain and review GMP documentation including validation reports, stability protocols, and technical reports
- Support audit readiness and inspections, providing analytical subject matter expertise
Cross-Functional Collaboration
- Act as the analytical subject matter expert across Quality, Regulatory CMC, Supply Chain, and Technical Operations
- Support post-approval changes and contribute analytical data for regulatory submissions
- Participate in change control and risk assessment activities impacting analytical methods or testing sites
Qualifications
Required
- BS, MS, or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related field
- 8+ years (BS), 6+ years (MS), or equivalent experience in analytical development, QC, or MSAT within a GMP-regulated environment
- Experience managing analytical activities across CMOs and CTLs for commercial products
- Strong expertise in:
- Chromatographic techniques (HPLC, GC)
- Dissolution testing and stability programs
- Compendial methods and quality control testing
- Solid understanding of cGMP and global regulatory requirements
Preferred
- Six Sigma certification (Green Belt or higher)
- Experience with analytical method transfers and external lab performance management
- Familiarity with fully outsourced/virtual pharma operating models
- Experience supporting regulatory submissions (e.g., NDA supplements, global variations) and inspections
Why This Role
- Play a critical role in ensuring product quality and supply continuity across a global manufacturing network
- Collaborate with cross-functional leaders and external partners in a highly visible position
- Contribute to operational excellence within a growing, innovation-focused organization
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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