Project Manager API Development Lead

1 week geleden


Oss, Noord-Brabant, Nederland Ardena Voltijd
About Ardena

Ardena is a leading contract development organization for the pharmaceutical industry, providing comprehensive and integrated services for drug substance and drug product development, manufacturing, logistics, and bioanalytical services.

Job Description

We are seeking a highly skilled Project Manager to lead our API/NANO development projects, ensuring timely and within-budget delivery of goals and objectives. As a key member of the core project team, you will act as Ardena's point of contact for customers and collaborate with PR&D Lead and Analytical Lead to drive project success.

Key Responsibilities
  • Translate customer demands and requests into proposals and work-orders, negotiating timelines and budgets with customers in collaboration with the core team and Quality Assurance and Business Development representatives.
  • Create realistic project plans for all stages, including Process and Analytical R&D, (non-)GMP manufacturing, batch release, stability studies, and related activities, working with the core project team and internal stakeholders to drive project delivery.
  • Monitor the project pipeline and placement of new projects with fellow PMs, business development, and line management.
  • Provide regular updates on timelines, deliverables, and budget, escalating potential issues internally and externally and proposing mitigation strategies when needed.
  • Engage in strategy discussions with customers, providing feedback and support on CMC-related questions.
  • Take full accountability for projects and contribute to problem-solving in case of issues.
  • Motivate team members and ensure alignment between internal stakeholders and customers.
Requirements
  • BSc, MSc, or PhD degree in (organic/analytical) chemistry, pharmacy, or toxicology, combined with extensive experience in the pharmaceutical industry.
  • In-depth knowledge of and experience with development and commercialization of pharmaceutical ingredients and/or pharmaceutical products.
  • Extensive experience with cGMP and CMC in the (pre)clinical development stages of development.
  • Strong organizational skills to oversee complex projects and monitor progress of individual tasks.
  • Strategic thinking within a commercial environment and strong communicative skills.
  • Flexibility, pragmatism, problem-solving, and team-player qualities.
  • Analytical mindset, stress resistance, and leadership skills.
  • Fluency in English (written and spoken), with knowledge of Dutch a plus.
What We Offer
  • A true learning environment for skill growth.
  • A rapidly developing and growing international company with an attractive services, product, and customer portfolio.
  • A dynamic working environment with nice colleagues.
  • An open, straightforward, but caring culture.
  • An attractive remuneration package, including a salary range between 3,500 and 6,300 depending on experience and qualifications.
  • Flexible working hours.
  • 30 days holiday a year.
  • Fruit and Fitness possibilities.

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