Associate Director, Analytical Technical Solutions - Millsboro, DE

** Job Description
** 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%.
*** Key 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
**
* Minimum 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, Open Lab Chem Station, or equivalent
* Experience in international, cross-functional project teams, with strong project management, communication, and stakeholder alignment skills
**
* Preferred qualifications:

**** 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

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