Senior Scientist, Molecule DP​/FP: Scale-Up & CMO Leadership

Position: Senior Scientist, Small Molecule DP/FP: Scale-Up & CMO Leadership
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.
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).

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…