SENIOR ANALYTICAL DEVELOPMENT MANAGER

Ferrer Internacional SA; Barcelona; Presencial; EUR 110.000 - 140.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible working model

Career development opportunities

Wellbeing support

Descripción de la vacante

Ferrer in Barcelona is seeking a Senior Analytical Development Manager to lead a multidisciplinary team responsible for analytical development of new products, including method development, validation and transfer. The role spans preclinical to late-stage clinical programs with regulatory submissions in EU and US.

You will drive scientific excellence, collaborate with cross-functional teams and ensure quality, compliance and timely delivery of development milestones in a fast-moving

Formación

• Advanced degree in Pharmaceutical Sciences, Chemistry, Analytical Chemistry or related scientific discipline. A PhD will be highly valued.
• Experience leading Analytical Development teams in pharma and strong regulatory exposure.
• Proven ability to guide method development, validation and transfer across programs.

Responsabilidades

• Lead, coach and develop the Analytical Development team, fostering scientific excellence.
• Direct analytical drug development activities across all stages of development and regulatory programs.
• Plan and allocate resources across multiple development programs.
• Provide scientific oversight of analytical methods and characterization techniques.
• Ensure compliance with ICH, GMP and pharmacopoeial requirements.
• Promote QbD and analytical lifecycle approaches in development.

Conocimientos

People leadership

Strategic prioritization

Scientific judgement

Stakeholder management

Cross-functional collaboration

Educación

Advanced degree in Pharmaceutical Sciences or related field (PhD valued)

Herramientas

HPLC

UHPLC

LC-MS/MS

GC

UV-Vis

FTIR

XRPD

DSC

TGA

Descripción del empleo

At Ferrer we use business to fight for social justice. We have long been a company that looks to do things differently; instead of maximizing shareholder returns, we reinvest much of our profit in initiatives that give back to society. Back where it belongs. We go beyond compliance and are guided by the highest standards of sustainability, ethics and integrity. As such, since 2022, we are a B Corp.

Founded in Barcelona in 1959, Ferrer offers transformative solutions for life-threatening diseases in more than one hundred countries. In line with our purpose, we have an increasing focus on pulmonary vascular and interstitial lung diseases and rare neurological disorders. Our 1,800-strong team is driven by a clear conviction: our business is not an end in itself, but a way to change lives.

We are Ferrer. Ferrer for good.

Yourmission

The Senior Analytical Development Manager will be responsible for leading and managing Analytical Development activities within the Pharmaceutical Development Department.

In this role, you will lead a team of Junior and Senior Scientists and Analysts, providing scientific and strategic direction across the analytical development of new products, mainly New Chemical Entities and small molecules, as well as supporting the improvement, troubleshooting and revalidation of analytical methods for marketed products.

Responsibilities

• Lead, coach and develop the Analytical Development team, fostering scientific excellence, collaboration, accountability and continuous improvement.
• Lead and drive analytical drug development activities across all stages of development, including method development, optimization, validation and transfer, supporting preclinical and Phase I–III clinical programs while ensuring regulatory compliance and the successful progression of development projects.
• Leadtheplanning,prioritizationandresourceallocationofAnalyticalDevelopmentactivitiesacrossmultipledevelopmentprograms,ensuringtimelydelivery,effectiveprojectexecutionandalignmentwithoveralldevelopmentobjectives.
• Bring strong hands-on scientific and technical expertise in analytical methods relevant to pharmaceutical development, including HPLC, UHPLC, LC-MS/MS, GC, UV-Vis and FTIR spectroscopy. Provide scientific oversight of the physicochemical and solid-state characterization of APIs, excipients and solid dosage forms using techniques such as XRPD, DSC, TGA, DVS, particle-size analysis, microscopy and Karl Fischer. Bring strong experience in dissolution testing, with the ability to provide scientific guidance on method development, discriminatory dissolution methods and studies using biorelevant dissolution media.
• EnsureAnalyticalDevelopmentactivitiesareconductedincompliancewithapplicableregulatoryrequirementsandguidelines,includingICH Q14, ICH Q2(R2), ICH Q8, ICH Q9 andrelevantICH Q1, Q3 and Q6guidelines, aswellas GMP, dataintegrityrequirementsandapplicablepharmacopoeias.
• Promote the application of Quality by Design (QbD) and analytical lifecycle principles, including Analytical Target Profile (ATP) definition, risk assessment, method understanding, robustness, validation and transfer.
• Draft, review and approve all relevant documentation related to Analytical Develoment.
• Ensure that Analytical Development data generated throughout development are sufficient to support regulatory submissions in both the EU and the US, including Marketing Authorisation Applications (MAAs) and, where applicable, NDAs/ANDAs, in compliance with current regulatory requirements and guidelines. Write, review and provide scientific input to the relevant analytical sections of regulatory dossiers.
• Supportinteractionswithregulatoryauthorities,includingresponsestoquestions,deficiencylettersandrequestsforclarification.
• Ensure laboratory facilities and equipment are appropriately maintained, qualified and calibrated as required, and that team members are adequately trained and kept up to date.
• Work closely with Formulation Development and other cross-functional teams, including Regulatory Affairs, Quality, Manufacturing and internal or external stakeholders, to support successful pharmaceutical development and project execution.

Why Ferrer?

• Make a positive impact in society
• Grow in a culture of trust, responsibility, and constructive feedback
• Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking
• Make a real difference to the team and to yourself
• Take advantage of opportunities for development & learning
• Discover a range of benefits to support your physical, emotional and financial wellbeing
• Customize your remuneration and benefit

Requirements

What you’ll need to succeed

You will rock at this company if you are a person with empathy, humility, curiosity and optimism.

You will rock at this role if you match with:

• Advanced degree in Pharmaceutical Sciences, Chemistry, Analytical Chemistry or a related scientific discipline. A PhD will be highly valued.
• Extensive experience in Analytical Development within the pharmaceutical industry, ideally covering projects from early development through late-stage development and registration.
• Proven experience leading and developing scientific teams within Analytical Develpment or Pharmaceutical Development environments.
• Strong background in analytical development of drug products, particularly solid orall dosage forms. Experience with liquids, suspensions and/or injectable products will be valued.
• Strong understanding of GMP and regulatory requirements applicable to pharmaceutical development.
• Experience supporting regulatory submissions and interactions with EMA, FDA or other major regulatory authorities.
• Experience working in cross-functional development teams and managing several development programs simultaneously.

Skillsandcompetencies

• Peopleleadershipandteamdevelopment.
• Strategicprioritizationandresourcemanagement.
• Strongscientificjudgementanddecision-making.
• Stakeholdermanagementandinfluencingskills.
• Cross-functionalcollaboration.

At Ferrer, we guarantee equal treatment and opportunities in recruitment, avoiding prejudices and stereotypes for any reason in the processes of access to the company, assessing only objective criteria such as professional and academic skills and work experience.

Sector: Pharmaceutical and biopharmaceutical