Biopharmaceutical Analysis Manager

Description

Summary: Seeking a strategic Biopharmaceutical Analysis Manager to lead technical transfer of analytical methods for Quality Control of Biologic Drug Products, providing both technical and operational leadership. Highlights: 1. Lead complex analytical projects for biologics under strict GMP/GLP compliance 2. Drive departmental excellence, client satisfaction, and continuous growth 3. Opportunity for professional development and a collaborative environment 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. **Requirements** * Bachelor’s degree in Biochemistry, Biotechnology, Pharmacy, Chemistry, or related Life Sciences field. Master’s degree or PhD is highly preferred. * Minimum 5 years of experience in Analytical Development, Technical Transfer, or Quality Control within the Pharmaceutical/Biotech industry, with at least 2 years in a managerial or supervisory role. * Strong experience in analytical testing and Quality Control of biologics, including monoclonal antibodies, biosimilars, vaccines, and recombinant proteins. * Extensive hands\-on expertise in HPLC/UPLC is essential; experience with CE, icIEF, SEC, ELISA, and potency assays is highly valued. * Proven experience managing analytical method transfers, validations, and regulatory documentation in GMP environments. * Strong knowledge of laboratory systems such as LIMS, Empower and electronic quality systems. * Solid understanding of regulatory expectations from FDA, EMA, ICH, and pharmacopeial standards. * Exceptional leadership, organizational, and communication skills to mentor laboratory scientists and analysts and manage multiple high\-stakes projects simultaneously. * Strong financial experience in budget control, forecasting, and operational planning. * Strong problem\-solving mindset with the ability to make decisions in complex, high\-pressure environments. * Advanced English level (C1 preferred) required to manage international clients, technical documentation, and cross\-functional collaboration. ***Preferred Competencies*** * Strategic thinking and decision\-making * High level of ownership and accountability * Strong customer orientation * Continuous improvement mindset * Ability to lead change and transformation * Cross\-functional collaboration and influence * Results\-driven with strong business orientation **If you join us, you will enjoy:** * Working in a dynamic company with a highly qualified growing team * Professional development and collaborative environment and a culture of empowerment. * Flexible Working Hours and intensive schedule on Friday. * Hybrid work, but mainly in the office. * Access to the employee benefits flexibility platform. * 23 vacation days per year plus 24th and 31th of December. * Fully stocked canteen and rooftop space (coffee, fruits, snacks, and beverages). * Our headquarters located in Cerdanyola del Vallés, an amazing place at the foothill of Collserola Park, the green lung of Barcelona, with our Rooftop terrace. *Kymos considers diversity and inclusion as key development priorities, with one of our main goals being to promote a culture that embraces differences and celebrates unique talents. For this reason, we are committed to equal opportunities for all people, regardless of gender, nationality, sexual orientation, gender identity, age, religion or any other personal characteristic*