Introduction
A seasoned CMC / Drug Product Development Specialist is sought for a key role within an ambitious biotechnology organisation focused on advanced subcutaneous biological therapies. This position offers the opportunity to shape and drive the development of clinical and commercial drug-product processes—from concept to market—while contributing to high-quality, patient-centred therapeutic solutions with long-term impact.

Key Responsibilities

• Lead the design and implementation of subcutaneous formulations and drug/combination-product manufacturing processes tailored to defined product and quality profiles.

• Oversee cGMP manufacturing for both clinical and commercial supply across various modalities (e.g., peptides, siRNA, biologics/antibodies), including formulation development, process optimisation, technology transfer, quality oversight and life-cycle management.

• Select, manage, and coordinate external development and manufacturing partners, suppliers, and consultants to ensure high-quality execution and adherence to timelines.

• Collaborate closely with cross-functional teams such as R&D, Quality, Regulatory Affairs and other key stakeholders to define strategy and execute CMC activities.

• Ensure that external partners comply with relevant regulatory standards and cGMP requirements.

• Contribute to preparation of regulatory documentation and support interactions with authorities as needed.

Success Profile
The ideal candidate brings strong scientific and analytical capabilities and excels at translating complex technical requirements into robust, GMP-compliant processes. This person operates proactively, takes ownership of deliverables, and thrives in a dynamic, cross-functional environment. Strong communication, stakeholder management, and project-coordination skills are essential, along with an ability to balance scientific rigour with practical execution.

Qualifications

• Master’s degree or equivalent in pharmaceutical sciences, chemical engineering, biotechnology or a related discipline.

• At least 5 years of industry experience working with complex subcutaneous therapeutic products and hands-on exposure to both early- and late-stage development for biologics/combination products.

• Expertise in formulation development (liquid and lyophilized), vial/syringe/combination-product development, stability and in-use studies, GMP fill-finish operations, technology transfer and commercialisation.

• Demonstrated experience managing outsourced activities and external manufacturing partners, as well as navigating regulatory and quality documentation within a cGMP framework.

• Strong project-management abilities, collaboration skills and capacity to work independently in an international and multidisciplinary setting.

Additional Note (Contribution to mission)
By stepping into this role, the selected candidate will play a key part in bridging advanced scientific innovation with real therapeutic outcomes—ultimately helping to bring life-changing treatments closer to patients.