Pharming Group

Scientist Drug Substance (Small Molecules) – Pharming Group – Leiden

Pharming Group

Jobid=b3bfc1a89971 (0.086)


About Pharming Group
Pharming Group is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. We are developing and commercializing a portfolio of innovative medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands, with a significant proportion of its employees based in the

Our Vision
Our Vision is to develop a leading global rare disease company with a diverse portfolio and presence in large markets, leveraging proven and efficient clinical development, supply chain, and commercial infrastructure.

Life at Pharming
Today more than ever, we're positioned to realize our vision of becoming a leading global rare disease company. Our success will come from everyone's commitment to our patients, our ability to work with focus and clarity, and our shared dedication to building something meaningful together. We can only achieve this by embracing our biotech culture, Life at Pharming, which is dynamic, experimental, and shaped by what we learn together.

The Role:

The Scientist Drug Substance – Small Molecules is involved in the manufacturing of one or more of Pharming’s Small Molecule Drug Substances and supports the development, scale-up, validation, and transfer of Drug Substance manufacturing processes.

This role contributes to the design and execution of development and manufacturing activities for Pharming's Small Molecule Drug Substances, across both clinical and commercial phases, with the goal of delivering high-quality products efficiently and robustly. The Scientist works closely with contract organizations to ensure successful execution.

The Scientist ensures that all processes comply with applicable quality regulations and that assigned tasks are completed within agreed timelines. The role may also serve as a Subject Matter Expert (SME) within the CMC Team or be part of a dedicated Drug Substance Small Molecules Team supporting CMC operations.

Key Accountabilities:

  • Design and execute studies for development, scale-up, validation, and transfer of Pharming's Small Molecule Drug Substance processes under supervision.
  • Plan work to meet deadlines in collaboration with the CMC team.
  • Manage contract manufacturing organizations for the development, scale-up, validation, and production of clinical and commercial Drug Substance batches.
  • Support CMC teams and maintain scientific oversight of manufacturing activities.
  • Prepare scientific reports, documentation, and presentations to communicate development progress and findings to internal teams and external stakeholders.

    • Regulatory Compliance & Quality Assurance:

  • Own and manage deviations, CAPAs, and minor changes, ensuring timely and high-quality resolution.
  • Troubleshoot manufacturing deviations and propose effective solutions.
  • Stay up to date with emerging trends, technologies, and regulatory requirements in pharmaceutical Drug Substance development and production.
  • Author and review development and validation reports, and contribute to relevant CMC sections of regulatory dossiers (IMPD/IND, NDA/MAA).
  • Respond to regulatory queries related to Drug Substance development and manufacturing.

    • Competencies:

  • Strong teamwork and collaboration.
  • Effective communication skills.
  • Analytical problem-solving.
  • Results-oriented approach.
  • Ability to act with urgency and adaptability.

    • Qualifications & Experience:

    Education:

  • PhD or MSc in Chemistry or Chemical Engineering.

    • Knowledge:

  • Strong understanding of regulatory guidelines (EMA, FDA, ICH).
  • Familiarity with current Good Manufacturing Practices (cGMP).
  • Excellent command of English, both written and verbal.

    • Experience:

  • Minimum 5 years of relevant experience in Drug Substance development.
  • Experience in the biotech/pharmaceutical industry is preferred.
  • Project management certification is a plus.
  • Experience managing contract organizations (CxOs) is a plus.


    • What you'll get in return
    We offer you a permanent position (starting with a one-year contract), with an excellent remuneration scheme, including:

  • A highly competitive salary
  • holiday allowance (for NL)
  • A minimum of 30 vacation days
  • An excellent pension plan
  • Commuting allowance

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    • Datum geplaatst:
    • Plaats: Leiden
    Deel deze vacature: