Senior Analytical Development Manager

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.

• 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.
• Lead the planning, prioritization and resource allocation of Analytical Development activities across multiple development programs, ensuring timely delivery, effective project execution and alignment with overall development objectives.
• 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.
• Ensure Analytical Development activities are conducted in compliance with applicable regulatory requirements and guidelines, including ICH Q14, ICH Q2(R2), ICH Q8, ICH Q9 and relevant ICH Q1, Q3 and Q6 guidelines, as well as GMP, data integrity requirements and applicable pharmacopoeias.
• 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.
• Support interactions with regulatory authorities, including responses to questions, deficiency letters and requests for clarification.
• 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.

• Make a positive impact in society
• Participate in volunteering activities
• 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

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.

• People leadership and team development.
• Strategic prioritization and resource management.
• Strong scientific judgement and decision-making.
• Stakeholder management and influencing skills.
• Cross-functional collaboration.

If this great challenge matches your profile, then we are waiting for you!

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.