Mission
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This position plays a key role in ensuring the scientific integrity, regulatory compliance, and strategic alignment of Ferrer’s R&D portfolio. The role combines technical expertise, cross‑functional coordination, and operational support to strengthen decision‑making and maximize the impact of R&D investments.
Key Responsibilities
Oversight of Nitrosamine Risk Management
- Lead the end‑to‑end oversight of nitrosamine risk assessment and mitigation strategies across Ferrer’s product portfolio.
- Ensure compliance with global regulatory requirements and evolving guidelines (e.g., EMA, FDA).
- Collaborate with Quality, Regulatory Affairs, and Manufacturing to maintain robust control strategies and lifecycle management plans.
Support to Robustness Processes
- Provide scientific and technical support in the investigation of complex product and process‑related issues.
- Contribute to root cause analysis, risk assessment, and definition of corrective and preventive actions (CAPAs).
- Facilitate cross‑functional collaboration to ensure effective and timely resolution of issues.
- Support knowledge management and continuous improvement initiatives derived from troubleshooting learnings.
Support to R&D Pipeline Program Management
- Assist in the coordination and tracking of R&D programs across the development pipeline.
- Support program governance by ensuring alignment of timelines, milestones, and deliverables with strategic objectives.
- Collaborate across functions to ensure efficient execution of development programs.
Maximization of R&D Investments
- Develop and consolidate robust scientific and technical justifications to support R&D projects within strategic frameworks (e.g., PROFARMA, tax incentives, fiscal deduction programs).
- Prepare documentation and evidence packages required for external programs, ensuring compliance with regulatory and financial criteria.
- Collaborate with Finance, Regulatory, Scientific, and Strategy teams to ensure consistency and robustness of inputs used in investment justification and reporting.
Cross‑functional Impact
- Act as a transversal role interacting with multiple departments, including Quality, Regulatory Affairs, Pharmaceutical Development, Manufacturing, Customer Service, and Commercial teams.
- Bridge scientific and business perspectives to enhance decision‑making in R&D.
- Contribute to maximizing the overall value and impact of R&D initiatives.
When You’ll Thrive
You will thrive in this role if you are a person with empathy, humility, curiosity, and optimism.
Requirements
- Degree in Chemistry, Pharmacy, Biochemistry, or a related field.
- Minimum of 5 years of experience in the pharmaceutical industry.
- Hands‑on laboratory experience (“white coat” background) is essential.
- Strong knowledge of late‑stage pharmaceutical development and/or quality processes.
- Experience in risk management (nitrosamines knowledge is highly desirable).
- Familiarity with global regulatory requirements (EMA, FDA).
- Experience in industrial troubleshooting and problem‑solving.
- Experience in pharmaceutical manufacturing environments (API and/or Drug Product) is highly desirable.
- Strong understanding of Quality Risk Management principles (ICH Q9).
- Experience in managing R&D programs.
- Ability to manage multiple complex programs in parallel with a strong results orientation.
- Strategic mindset combined with hands‑on execution.
- Strong communication skills to bridge scientific and business stakeholders.
- Proven ability to work in cross‑functional and multicultural environments.
- Influencing and stakeholder management capabilities.
- Learning agility, adaptability, and collaborative mindset. xqbhyrx
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.
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