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Merck · 10 hours ago

Associate Director, Analytical Technical Solutions - Millsboro, DE

Millsboro, DE

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$129K/yr - $203K/yr

6+ years exp

Merck is a global healthcare company committed to improving health and well-being. The Associate Director, Analytical Technical Solutions is responsible for overseeing analytical lifecycle management for biologics, leading a small team, and ensuring collaboration across various departments to enhance manufacturing workflows and analytical methods.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

Analytical Method DevelopmentLiquid Chromatography (LC)Liquid Chromatography-Mass Spectrometry (LC-MS)Monoclonal AntibodiesAnalytical Method TransferBiologicsDrug Product ManufacturingTechnical TransferLeadershipTeam Management

Required

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