Head Upstream Process (USP)

Primary objectives & goals

The Head Upstream Process (USP) is leading the USP team and designs, executes and interprets experiments to set up the development of cell lines and cell banks, the fermentations and all related processes, and manages the associated infrastructure including the according documentation (protocols, reports, SOPs), batch releases of raw material, material shipments, and laboratory equipment monitoring.

Scope & Responsibility

• Lead and manage the USP team.
• Represent USP for the assigned portfolio at management and external stakeholder levels.
• Oversees all USP programs and projects, guides teams to ensure cross-functional integration, coordination and alignment.
• Ensures direct reports are actively and appropriately aligning with other teams to ensure timely and on-target results.
• Provides leadership guidance and direction in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources.

Overall team’s responsibility:

• Support establishment of new platform technologies for high throughput upstream process development using mammalian cell cultures.
• Design, plan, organize, execute and analyse experiments to develop and execute the transfer (scale up) of processes in to production facilities.
• Supports the development of new experimental approaches and related work processes and procedures that align with company and regulatory requirements.
• Conduct test runs.
• Keep records in electronic laboratory notebooks, and authoring of procedures, protocols, technical reports, standard operating procedures (SOPs) and presentations.
• Release batches, organize and oversee shipments to and from external stakeholders, support Clinical Study logistics.
• Operate Upstream Process GMP production.

Desired Professional and Technical Requirements

Education/Qualifications

• Completed studies, preferably MSc or PhD, in Biotechnology, Biology, Chemistry, Engineering, or a comparable degree with corresponding professional experience.

Experience, Skills, Knowledge

• At least 4-year experience in upstream process development and manufacturing techniques.
• Strong track record with mammalian cell cultures (e.g. CHO, SP2/0) and knowledge of cultivation techniques.
• Experience with single-use bioreactors from mL-scale to 200 L production scale favourable
• Leadership/management experiences.
• Knowledge of biopharmaceutical active substance production and analytics.
• Good knowledge of English written and oral.