FDF INDUSTRIALISATION MANAGER

Job Description

About Our Client:

Our client is a well-established pharmaceutical company based in Malta, recognized for its dedication to developing and manufacturing high-quality active pharmaceutical ingredients and finished dosage forms. With a strong presence in Europe and the US, the company maintains rigorous standards of compliance, quality, and innovation. As part of their continued growth, they are seeking an experienced FDF Industrialisation Manager to join their Research and Development team.

The Role:

We are looking for a highly skilled and proactive FDF Industrialisation Manager to join our client’s Research and Development department. This role is pivotal in coordinating all R&D functions related to the industrialization and validation of processes, ensuring seamless technical transfers, and maintaining compliance with regulatory standards. The ideal candidate will have extensive experience in pharmaceutical production processes, a solid understanding of regulatory requirements, and strong project management skills.

Main Duties and Responsibilities:

R&D Coordination:

• Oversee the industrialization and validation of processes from internal formulation teams or third-party sources.
• Manage technical projects, liaising with internal and external clients to ensure successful outcomes.
• Provide technical support to the manufacturing plant when needed.

Project Management:

• Evaluate contract project proposals and ensure they align with company objectives.
• Coordinate and manage R&D projects, ensuring they meet timelines and regulatory requirements.

Technical Expertise:

• Utilize expertise in finished dosage form production processes to guide project development.
• Ensure compliance with EMA and FDA regulatory requirements.
• Drive validation processes within the pharmaceutical sector to maintain high standards of quality.

Leadership and Collaboration:

• Lead R&D initiatives, working closely with cross-functional teams to achieve project goals.
• Foster a collaborative environment that promotes teamwork and continuous improvement.

Requirements:

Education:

• A University degree in Chemistry or Pharmacy is required; postgraduate studies are highly desirable.

Experience:

• Proven experience in finished dosage form production processes and technical transfers within the pharmaceutical industry.
• Strong knowledge of regulatory requirements in key markets such as EMA and FDA.
• Experience in validation processes and project management.

Skills:

• Exceptional leadership and communication skills.
• Highly organized, with strong problem-solving abilities and project planning capabilities.
• Ability to work independently as well as part of a management team.

Why Join Us:

• Continuous opportunities for professional growth and training.
• Competitive remuneration package, including health insurance and medical check-ups.
• A supportive working environment with a focus on teamwork and employee well-being.
• Job security with a reputable pharmaceutical company in Malta.

How to Apply:

If you meet the above criteria and are ready to contribute to a dynamic and innovative R&D team, we invite you to apply. Please submit your CV and a cover letter outlining your relevant experience and why you are the ideal candidate for this position.

Our client is committed to diversity and inclusion. Applications from all qualified candidates are welcome, regardless of age, gender, ethnicity, disability, sexual orientation, or religion.