Senior Scientist Drug Product / Final Product Development for Small Molecules.

Pharming Group; Leiden; On-site; EUR 110,000 - 140,000; Full time

Benefits offered by this job

Competitive salary

8.33% holiday allowance

30 vacation days

Pension plan

Job summary

Pharming Group in Leiden seeks a Senior Scientist – Small Molecule DP/FP to lead development, scale‑up, validation and transfer of drug product processes. You will design packaging and manage CMOs for clinical and commercial batches, while contributing to regulatory filings and cross‑functional CMC strategies.

The role requires 10+ years in pharma/biotech with 5+ years in DP/FP. Strong CGMP knowledge and English communication are essential.

Qualifications

• PhD or MSc in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related discipline.
• Min 10+ years of relevant pharma/biotech experience.
• At least 5+ years hands-on in small molecule DP/FP development.
• Experience managing Contract Manufacturing Organizations (CMOs).
• Experience across clinical and commercial manufacturing.
• Project management experience is an advantage.
• Experience with other modalities is a plus.

Responsibilities

• Independently lead design and execution of advanced studies for development, scale-up, validation, and process transfer of small molecule drug products.
• Drive design and implementation of primary and secondary packaging solutions.
• Manage external CMOs for development, manufacturing, and validation of clinical and commercial batches.
• Represent DP/FP expertise within cross-functional CMC teams.
• Plan, prioritize, and deliver work to meet timelines and budgets.
• Author and present scientific reports and updates to stakeholders.
• Ensure knowledge transfer across teams and mentor junior scientists.
• Support business development by assessing manufacturing implications.

Skills

DP/FP development

CMO management

Regulatory awareness

CGMP knowledge

Project management

Leadership

Education

PhD in Pharmaceutical Sciences

MSc in Chemistry

Job description

About the Role

Senior Scientist Drug Product / Final Product Development for Small Molecules.

As a Senior Scientist – Small Molecule Drug Product / Final Product (DP/FP), you will act as the subject matter expert (SME) for DP and FP manufacturing of Pharming’s small molecule portfolio. You will lead the development, scale-up, validation, and transfer of drug product processes, as well as the design of primary and secondary packaging for final products.

Working closely with Contract Manufacturing Organizations (CMOs), you will play a critical role in bringing products from clinical development through to commercial launch. As part of the Chemistry, Manufacturing & Controls (CMC) team, you will contribute to defining and executing development strategies that ensure successful regulatory approval and commercialization.

• Leiden

Key Responsibilities

Execution & Leadership

• Independently lead the design and execution of advanced studies for development, scale-up, validation, and process transfer of small molecule drug products.
• Drive the design and implementation of primary and secondary packaging solutions.
• Manage external CMOs for development, manufacturing, and validation of clinical and commercial batches.
• Represent DP/FP expertise within cross-functional CMC teams, aligning strategies with overall development goals.
• Plan, prioritize, and deliver work to meet timelines and budgets.
• Author and present scientific reports, technical documentation, and updates to internal and external stakeholders.
• Ensure knowledge transfer across teams and mentor junior scientists.
• Support business development activities by assessing manufacturing implications.

Regulatory Compliance & Quality

• Own and manage complex deviations, CAPAs, and change controls, ensuring timely and compliant resolution.
• Troubleshoot manufacturing challenges and deliver innovative, science-driven solutions.
• Stay current on regulatory requirements (EMA, FDA, ICH) and emerging industry trends.
• Write and review development reports, validation documentation, and CMC dossier sections (IMPD, IND, NDA/MAA).
• Act as SME in interactions with regulatory authorities, addressing complex questions.

Your Profile

Education

• PhD or MSc in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline.

Experience

• Minimum 10+ years of relevant experience, ideally within pharma/biotech.
• At least 5+ years of hands-on experience in small molecule DP/FP development.
• Proven experience managing Contract Manufacturing Organizations (CMOs).
• Experience across clinical and commercial manufacturing.
• Project management experience is an advantage.
• Experience with other modalities is a plus.

Knowledge & Skills

• Strong understanding of cGMP and global regulatory guidelines (EMA, FDA, ICH).
• Expertise in solid dosage form development and manufacturing.
• Excellent English communication skills (written and verbal).

Who we are

We’re built on a simple belief: people living with rare diseases deserve more.

Pharming is a global biotechnology company taking on some of the toughest rare disease challenges. We develop and commercialize innovative therapies for rare and ultra-rare immunological and genetic diseases with significant unmet need, where our scientific and commercial expertise, long-term commitment, and real partnership can help advance care.

We put patients at the heart of our work. Their insights, along with those of caregivers, clinicians, scientists, and partners, shape our strategy, guide our decisions, and help turn science into meaningful progress.

What it’s like to work here

At Pharming, every role helps move rare disease therapies closer to the people who need them. We make it happen together, across teams, disciplines, and borders, because breakthroughs don’t happen in silos. Rare diseases are complex, and meaningful progress takes people who ask better questions, challenge each other, and turn insight into action. Here, you won’t work on the sidelines. Pharming is a place for builders, problem-solvers, and bold thinkers who move with urgency, take ownership, and stay focused on what matters most: improving the lives of people living with rare diseases.

In addition, we offer:

• Competitive year salary
• 8.33% holiday allowance
• A minimum of 30 vacation days for a healthy work-life balance
• Excellent pension plan to secure your future