We are seeking a highly experienced, strategic, and results-driven Biopharmaceutical Analysis Manager to lead our Biopharmaceutical Analysis Department, focused on Technical Transfer of Analytical Methods for Quality Control of Drug Products of Biologic origin.
Reporting directly to the Biologics Area Manager, this role will provide both technical and operational leadership, ensuring the successful delivery of complex analytical projects involving biological products such as Biosimilars, Monoclonal Antibodies, Vaccines, Recombinant Proteins and other advanced biologics, under strict GMP/GLP compliance.
The successful candidate will combine strong scientific expertise, leadership capabilities, regulatory knowledge, and business vision to drive departmental excellence, client satisfaction, and continuous growth.
Key Responsibilities
Department Leadership & Strategic Management
* Lead, organize, and strategically plan all Biopharmaceutical Analysis projects and analytical method transfer activities.
* Define departmental objectives aligned with company strategy, ensuring operational excellence, scientific quality, and profitability.
* Manage department resources, including personnel (team of 10+ analysts/scientists), workload distribution, shift planning, laboratory capacity, and high-end analytical instrumentation.
* Develop team capabilities through coaching, mentoring, performance management and talent development.
* Promote a strong culture of quality, compliance, accountability, and continuous improvement within the department.
* Identify opportunities for process optimization, operational efficiency, and service portfolio expansion.
Technical & Scientific Oversight
* Direct supervision and scientific leadership of analytical method transfer, verification, validation, and troubleshooting studies for biological products.
* Ensure projects are delivered on time, within budget, and according to client expectations and regulatory standards.
* Provide expert technical support in complex analytical techniques including HPLC/UPLC, CE, icIEF, SEC, electrophoretic techniques, ELISA, UV, potency assays, and other characterization methods for biologics.
* Lead root cause investigations and resolution of complex technical issues affecting analytical performance or project timelines.
* Review and approve technical documentation including protocols, reports, SOPs, specifications, validation documentation, and Certificates of Analysis.
Quality & Regulatory Compliance
* Ensure full compliance with GMP, GLP, Data Integrity, and applicable regulatory requirements.
* Manage, review, and approve Incidents, Deviations, OOS/OOT investigations, Change Controls, Risk Assessments, and CAPAs within the department.
* Support internal audits, client audits, and regulatory inspections (FDA, EMA, AEMPS, MHRA, etc.), acting as key departmental representative.
* Ensure inspection readiness and continuous compliance of laboratory operations and documentation practices.
Client & Business Management
* Act as the primary technical contact for clients, ensuring high-level scientific communication, project alignment, and long-term relationship development.
* Collaborate with Business Development and Marketing teams to support new business opportunities, proposals, and technical feasibility assessments.
* Provide scientific and operational input for new services, customer onboarding, and strategic business growth initiatives.
* Monitor departmental budgets, billing, profitability, and resource allocation.
* Propose the annual service sales budget and annual investment plan for the Biopharmaceutical Analysis Department for approval by company management.
* Propose the annual training plan for the Biopharmaceutical Analysis Department for approval by company management.
* Monitor and review key performance indicators (KPIs) related to quality, productivity, profitability, and on-time delivery.
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