To further strengthen our Drug Substance (DS) commercial manufacturing team, we are looking for a talented Scientist External Manufacturing. This position offers a unique opportunity to support the build out and shape of our global manufacturing network for innovative pharmaceutical products.

KEY ACCOUNTABILITIES AND RESPONSIBILITIES:

• Support the execution of commercial drug substance (DS) manufacturing at external parties and secure timely delivery of DS batches at the required quality; all in close collaboration with the project team and the quality organization;


• Ensure real time oversight of at scale batch manufacturing through continuous process verification and record review of critical process steps;


• Identify opportunities for process improvements;


• Facilitate the establishment of integrated CMC operational plans with internal and external service providers by providing technical input, problem resolution definition and priority setting, in combination with overseeing their execution, scope and budget;


• Support the continuous effort on cost of goods reduction;


• Support quality/technical review of CMC documents (batch manufacturing records, batch summary reports, APR, in-process data...) and GMP quality documents (e.g. change requests, deviations, ....) with minimal guidance and able to draw appropriate conclusions;


• Support review of module 3 DS sections in support of clinical trial as well as licensure applications;


• As a member of the CMC team actively contribute to technical and strategic CMC discussions;


• Proactively identify and track project critical path items - identify risks, formulate and monitor corrective actions;


• Provides input to budget forecast cycles and contribute to the financial tracking of outsourced activities.

QUALIFICATIONS AND SKILLS:

• Works independently within the scope of his assigned field and supports others;


• Stay up to date with relevant scientific and/or technical developments. Searches literature and other sources independently and applies knowledge;


• Excellent organizational and coordination skills leans training and/or qualification is a plus;


• Ability to go into detail whilst keeping the view on the overall project goal;


• Ability to communicate effectively with internal and external stakeholders;


• Flexible attitude, capable to balance multiple priorities;


• Quality conscious attitude;


• Hunger for learning and development;


• Data oriented;


• Agile thinking.

EDUCATION AND EXPERIENCE:

• Masters degree in chemistry, pharmaceutical sciences, bio-engineering, or other discipline within pharmaceutical/biotechnology sciences;


• Technical expertise in the field of biological drug substance manufacturing, (process characterization, process validation, continued process verification and/or commercial manufacturing) in combination with good project management skills;


• Knowledge of ICH and GMP regulations;


• >3y within relevant industry experience;


• Fluent in English, written and spoken;


• Experience in data management is a plus;


• Expertise in statistical analysis is a plus.

OFFER:

• A competitive salary package with extensive benefits;


• Work in a cross functional environment, with many different internal and external stakeholders;


• A position in a human-sized, dynamic and rapidly growing biotech company;


• Opportunity to contribute to the build out of a global manufacturing network for innovative pharmaceutical products.