Job opportunities

Job description

For a commercial biopharmaceutical company, we are looking for a CMC Sr. Scientist Drug Substance to further strengthen their CMC DS Science team.    The company creates and develops a pipeline of differentiated antibody therapeutics. He/she will be leading technology transfer and scale-up of a drug substance (DS) manufacturing process, as well as process characterization and process qualification activities for a novel therapeutic antibody. This is a unique opportunity to work in the heart of a development and commercial organization in close collaboration with different CMC disciplines.

KEY ACCOUNTABILITIES AND RESPONSIBILITIES

• Lead, in collaboration with internal and external stakeholders, the technology transfer of drug substance processes (upstream and downstream) to external manufacturing sites.  

In this role you will be:

• Responsible for delivering the project in close collaboration with all relevant stakeholders, and be responsible for effective communication on progress,
• Responsible for review of tech transfer and manufacturing documentation such as risk assessments, facility fit analysis, gap analyses, process descriptions, sample plans and batch records,
• Expected to drive process optimizations from obtained data learnings;

• Lead process characterization activities in context of a potential commercial process design and validation;
• Review CMC DS dossier sections to support timely submission of clinical trial applications and (s)BLA/MAA/J-MAA filings;
• 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 and communicate risk to CMC leadership;
• Work in close collaboration with quality assurance to ensure activities are performed in line with the required quality standards and to ensure inspection readiness;
• Provides input to budget forecast cycles.

QUALIFICATIONS

• PhD in chemistry, pharmaceutical sciences, bio‐engineering, or other discipline within pharmaceutical / biotechnology sciences
• Strong technical expertise in the field of biological drug substance manufacturing, tech transfer and scale up, process validation, or commercial manufacturing
• Expected experience: >5y within relevant industry
• Relevant experience in project management and outsourced activities
• Fluent in English, written and spoken
• In depth knowledge of ICH and GMP regulations;
• Works independently within the scope of his assigned field and supports others;
• Keep abreast with relevant scientific and/or technical developments. Searches literature and other sources independently and applies knowledge;
• Excellent organizational and coordination skills;
• Ability to go into detail whilst keeping the view on the overall project goal;
• Strong technical expertise combined with good project management skills and ability to communicate effectively with internal and external stakeholders;
• Flexible attitude, capable to balance multiple priorities;
• Quality conscious attitude;
• Experience and knowledge in the preparation of regulatory submissions;
• Able to operate in a dynamic surrounding of a fast-growing biotech company with challenging timelines;

WHAT THE COMPANY OFFERS

• A competitive salary package with extensive benefits
• Front seat in the development of therapeutic antibodies
• A work environment in a human-sized, dynamic and rapidly growing biotech company