Biopharmaceutical Analysis Manager

Location: Bellprat

KYMOS GROUP is a medium-size and fast-growing Contract Research Organization (CRO) with headquarters in Spain and laboratories in Spain (Cerdanyola del Vallés
- Barcelona), Italy (Monsano-Ancona), and Germany (Frankfurt) and a Liasson office in South Korea (Seoul), offering comprehensive bioanalytical and CMC analytical services to the life sciences industry. Its laboratories are GMP and GLP certified and GCP compliant, and have been successfully inspected by EMA, FDA, and ANVISA.

KYMOS GROUP is devoted in providing high quality and added value services to its partners and it is highly oriented to innovation, offering services of research, development and quality control in many different fields such as small molecules, proteins, antibodies, nucleic acids, and advanced therapies.

KYMOS GROUP has a young and dynamic staff of more than 250 employees, and it is committed in promoting diversity, gender-equality, well-being, and initiative within its members, encouraging career development and internal promotion.

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.

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