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

Pharming Group; Leiden; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

8.33% holiday allowance

30 vacation days

Excellent pension plan

Job summary

Pharming Group in Leiden is looking for a Senior Scientist for their Small Molecule Drug Product/Final Product team. You will oversee the development, scale-up, and validation of drug product processes and packaging.

Your role involves leading studies, managing CMOs, and ensuring regulatory compliance while mentoring junior scientists. Ideal candidates have a PhD or MSc and significant experience in pharma/biotech.

The position offers competitive salary and benefits including vacation days and a pension plan.

Qualifications

• Minimum 10+ years of relevant experience in pharma/biotech.
• At least 5+ years of hands-on experience in small molecule DP/FP development.
• Proven experience managing Contract Manufacturing Organizations (CMOs).

Responsibilities

• Lead design and execution of advanced studies for drug product development.
• Manage external CMOs for development, manufacturing, and validation.
• Ensure knowledge transfer across teams and mentor junior scientists.

Skills

cGMP understanding

Solid dosage form development

Excellent English communication skills

Education

PhD or MSc in Pharmaceutical Sciences, Chemistry or Chemical Engineering

Job description

About the Role

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.

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).

Benefits

• 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