Jobid=fff7f3013f17 (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.
Purpose of the Role
The Senior Scientist Analytical – Small Molecules (SM) serves as the subject matter expert (SME) in analytical methods for one or more of Pharming’s Small Molecule programs, covering both Drug Substance and Drug Product. This role is responsible for the development, transfer, validation, and execution of robust and efficient analytical methods.
Operating independently, the Senior Scientist leads the design and oversees the development and implementation of analytical methods across clinical and commercial phases. This includes ensuring methods are transferable and fit-for-purpose, in close collaboration with external contract organizations.
The Senior Scientist ensures all activities are conducted in compliance with applicable quality regulations, and that deliverables are met within agreed timelines and budget.
As the analytical SME within CMC project teams, the Senior Scientist acts autonomously, providing expert guidance and strategic input to support Pharming’s Small Molecule development efforts.
Areas of responsibility:
Independently lead the design and execution of (advanced) analytical methods for development, transfer, validation, and routine testing for Pharming's SM.
Manage contract manufacturing/laboratory organizations for the development, transfer, validation of analytical methods and routine testing of clinical and commercial Drug Substance/Drug Product Small Molecule (SM) batches.
Represent analytical Small Molecules (SM) in CMC teams and align the analytical Small Molecules (SM) strategy with the overall CMC strategy and if applicable lead a subteam of Analytical Small Molecules (SM) scientists (product related).
Plan and prioritize work in collaboration with the CMC team to ensure deadlines are met and costs remain within budget.
Independently generate scientific reports, documentation, and presentations to communicate Analytical SM development progress and findings to internal teams and external stakeholders.
Ensure transfer of knowledge and processes to internal ( CMC team, DevOps) and external stakeholders ( CMO). Mentor scientists and onboard new Analytical SM scientists on the product.
Can be involved in Business Development projects to estimate the impact on manufacturing packages.
Regulatory Compliance and Quality assurance:
Own (complex) deviations/CAPAs/(major) changes (right quality, timely). Troubleshoot and report results when (complex) analytical Small Molecules (SM) deviations occur (clinical and commercial production) and provide innovative solutions to overcome challenges.
Stay abreast of emerging trends, technologies, and regulatory requirements in pharmaceutical Analytical Small Molecules (SM) development.
Independently write or review Analytical Small Molecules (SM) development and validation reports, relevant (more complex) CMC sections of the dossier (IMPD/IND and/or NDA/MAA), and respond to (more complex/strategic) regulatory questions.
Be involved as Analytical Small Molecules (SM) subject matter expert (SME) in discussions with regulatory agencies.
Knowledge:
A PhD/MSc in Pharmaceutical Sciences, Analytical Sciences, Biochemistry, or related discipline
Knowledge of regulatory guidelines (EMA, FDA, ICH) and current Good Manufacturing Practices (cGMPs)
Excellent knowledge of English language, both verbal and in writing.
Experience:
> 10 years of functional experience. Commercial experience is a plus.
> 5 years of experience in biotech/pharma in a relevant area including experience with Analytical SM.
Proven project management experience. Project management certification is a plus.
Proven experience in managing CxO’s.
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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