Associate Director, Analytical Technical Solutions - Millsboro, DE

Merck•Millsboro, DE

12h•Hybrid

About The Position

The Associate Director, Analytical Technical Solutions is a senior leadership role within US Analytical Technology Solutions (US-ATS), accountable for analytical lifecycle management across early- and late-stage biologics, with emphasis on monoclonal antibodies (mAbs), vaccines, and protein therapeutics. The role oversees development, validation, transfer, and continuous improvement of chromatography- and LC-MS–based methods, provides subject matter expertise for drug substance and drug product release and characterization assays, and ensures seamless integration of analytical methods into manufacturing workflows. The position carries responsibility for leading a small team, guiding regional innovation initiatives, and maintaining robust collaboration across R&D, QC, QA, Regulatory Affairs, manufacturing, and external partners. Travel requirement: 10–25%. Our Manufacturing & Supply Division operates an interdependent global network with external contractors, suppliers, and partners, focused on reliable, high-quality supply of Animal Health biopharmaceuticals to customers and patients—on time, every time. This role is positioned to evolve into a regional innovation team lead, advancing analytical lifecycle management and next-generation technologies across the network.

Requirements

Master’s degree with 9+ years of experience in analytical biochemistry, pharmaceutical sciences, molecular biology, biotechnology, or related discipline, with progressive technical leadership in large-molecule analytics; OR - PhD with 6+ years of experience in analytical biochemistry, pharmaceutical sciences, molecular biology, biotechnology, or related discipline, with progressive technical leadership in large-molecule analytics
Demonstrated expertise in mAb and protein therapeutic characterization; practical, hands-on experience with LC/UPLC/FPLC/SEC and LC-MS–based methods
Proficiency across key analytical modalities: UV-Vis, SDS-PAGE, Western blot, CE-SDS, HPLC/UPLC/FPLC, HPLC-SEC, LC-MS, ELISA, activity assays; experience with cell-based assays preferred
Proven leadership managing small teams (2–5 direct reports) and delivering complex method transfers and lifecycle management in a matrixed environment
Comprehensive knowledge of GMP, USDA, FDA, ICH guidelines and bioprocess operations relevant to biologics manufacturing
Competence in statistical evaluation of analytical data and use of CDS platforms such as Empower, Chromeleon, OpenLab ChemStation, or equivalent
Experience in international, cross-functional project teams, with strong project management, communication, and stakeholder alignment skills

Nice To Haves

Deep, hands-on expertise in biochemical analysis and characterization of monoclonal antibodies and protein therapeutics
Experience driving analytical innovation initiatives and introducing new technologies across regional or global networks

Responsibilities

Lead analytical lifecycle management activities for biologics, including method development, validation, transfer, and comparability assessments
Direct chromatographic and LC-MS platforms for characterization and release testing (e.g., intact/reduced mass, peptide mapping, glycan mapping, charge variants)
Serve as subject matter expert for protein/mAb analytical control strategies, specification setting, stability program design, impurity profiling, and degradation pathway assessment
Oversee site-to-site and R&D-to-site analytical transfers and integration into drug substance and drug product manufacturing processes
Author, review, and approve analytical protocols, reports, test plans, and stability protocols; ensure compliance with GMP/USDA/FDA/ICH guidelines
Lead and support investigations (OOS/OOT), root cause analysis, CAPA, and change control; partner with QC to evaluate method performance and assay robustness
Maintain strong internal and external collaborations for assay development, validation, and lifecycle improvements
Manage primary/working reference standards and critical reagents, including qualification, distribution, and long-term stewardship
Plan and manage budgets, resources, and staffing; mentor and develop a high-performing team
Oversee instrumentation strategy, including procurement, qualification, maintenance, and vendor management for HPLC, UPLC, FPLC, LC-MS, and related platforms
Monitor and assess emerging analytical technologies; contribute to regional innovation leadership and technology introduction