Title: API / ADC Manufacturing Scientist (Manager Level)

Reports to: Formulation Director

Location: Frankfurt

The Company

One of the world’s most innovative biotechnology companies are continuing their global expansion across Europe, North America, Africa, and the Asia Pacific (APAC). Due to this, their post-market surveillance phase of the organization is exploding to deliver essential medicines in the development of immune-therapy and oncology medicines to patients across the globe. Combining ground-breaking research, cutting edge technology, and pioneering immunotherapies, they are aiming to become the worlds leading biopharmaceutical company within the next few years.

The Role

As a API Manufacturing Scientist, specializing in Linker-Payload and Lipid Processes, you'll be an integral part of the team overseeing antibody drug conjugates (ADCs). Your role involves providing scientific and technical guidance for linker-payload manufacturing in ADC commercial programs. Additionally, you'll be responsible for reviewing and approving both external and internal documentation to meet regulatory requirements.

Responsibilities:

• Adapt, optimize, and implement manufacturing processes for efficient and high-quality production.
• Manage communication between internal stakeholders and manufacturing partners to ensure smooth operations.
• Review and approve project documentation, including investigation reports and regulatory filings.
• Drive continuous improvement in manufacturing processes and data quality through technological optimization.
• Implement and monitor key performance indicators (KPIs) and manage process risk effectively.

Requirements:

• Master’s or preferably PhD in organic chemistry with at least 5 years of relevant experience.
• Expertise in chemical manufacturing processes, particularly for Active Pharmaceutical Ingredients (APIs).
• Familiarity with analytical technologies for chemical analysis.
• CMC / Manufacturing backgrounds. 3 to 5+ Years experience.
• Knowledge of EU/US GMP guidelines and regulatory standards.
• Excellent communication skills in English, both written and verbal.

Benefits:

• Flexible working hours.
• Company pension scheme and childcare support.
• Transportation benefits such as job tickets and company bikes.
• Fitness courses and leave account options.

Email applicants, please forward to E-Mail schreiben with a copy of your CV and your availability for a screening call.