Scientist Biologics
About Pharming Group N.V.
Pharming Group N.V. 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 U.S.
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.
Purpose of the Role:
The Scientist Biologics is responsible for supporting the development, scale-up, validation, and manufacturing of Pharming’s Biological Drug Substances (Drug Substance) and Drug Products (Drug Product). This role contributes to the design and execution of development and manufacturing activities for biological products in both clinical and commercial phases, with the goal of delivering high-quality products in a robust and efficient manner.
The Scientist works closely with contract organizations and ensures that all processes comply with applicable quality regulations and timelines. The role may serve as a Subject Matter Expert (SME) within the CMC Team or be part of a dedicated Biologics Drug Substance/Drug Product Team supporting CMC operations.
Key Responsibilities:
Execution:
- Design and execute studies for development, scale-up, validation, and transfer of Pharming’s biological products under supervision.
- Plan and prioritize work to meet project deadlines in collaboration with the CMC team.
- Manage contract manufacturing organizations for the development, scale-up, validation, and production of clinical and commercial batches of biological Drug Substance and Drug Product.
- Maintain scientific oversight of manufacturing activities and support CMC teams.
- Prepare scientific reports, documentation, and presentations to communicate development progress and findings to internal 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 current with emerging trends, technologies, and regulatory requirements in biological Drug Substance and Drug Product 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 biologics development and manufacturing.
Competencies:
- Strong teamwork and collaboration.
- Effective communication across multidisciplinary teams.
- Analytical problem-solving abilities.
- Results-oriented mindset.
- Ability to act with urgency and adaptability.
Qualifications & Experience:
Education:
- PhD or MSc in Chemistry, Chemical Engineering, or a related field.
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 biologics Drug Substance and Drug Product 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
- 8.33% holiday allowance (for NL)
- A minimum of 30 vacation days
- An excellent pension plan
- Commuting allowance
Apply for the job
Does this sound like you and do you want to join our team? Then we'd love to hear from you!
We’re an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.