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Senior/Principal Scientist Drug Substance Sciences
Job description
For a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics, we are looking for a motivated Principal / Senior Scientist Drug Substance Sciences to further strengthen the CMC team. The scientist will play a key role supporting Chemistry, Manufacturing and Controls (CMC) development of the therapeutic antibodies and Fc engineered molecules. He/she will drive in collaboration with internal and external teams the process development, manufacturing and characterizing of antibody therapeutics by bringing technical and scientific CMC mastery to the table. The scientist utilizes his expertise to resolve obstacles and by bringing creative solutions to the table. In return we offer a seat in the hard of the development engine of a fast-growing biotech company with a promising product pipeline.
JOB DESCRIPTION
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Drive 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;
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Ensure real time oversight of at scale batch manufacturing through continuous process verification and record review of critical process steps;
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Identify opportunities for process improvements;
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Support process transfers across GMP facilities;
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Facilitate the establishment of integrated CMC operational plans with internal and
external service providers by providing expert input, problem resolution definition and
priority setting and oversee their execution, scope and budget;
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Critical quality / technical review of CMC documents (batch manufacturing records, batch summary reports, APR, ...) and GMP quality documents (e.g. change requests,
deviations, ....) with minimal guidance and able to draw appropriate conclusions;
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Review module 3 DS sections in support of clinical trial as well as licensure applications;
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Act as CMC lead at cross functional meetings;
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As a member of the CMC team actively contribute to technical and strategic CMC
discussions;
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Proactively identify and track project critical path items - identify risks, formulate and
monitor corrective actions;
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Provides input to budget forecast cycles.
Skills and personality
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PhD in chemistry, pharmaceutical sciences, bio-engineering, or other discipline within pharmaceutical / biotechnology sciences with >5y relevant industry experience;
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Strong 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;
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Experience in managing outsourced activities is a plus;
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In depth knowledge of ICH and GMP regulations;
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Works independently within the scope of his assigned field and supports others;
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Stay up to date with relevant scientific and/or technical developments. Searches
literature and other sources independently and applies knowledge;
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Excellent organizational and coordination skills;
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Ability to go into detail whilst keeping the view on the overall project goal;
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Ability to communicate effectively with internal and external stakeholders;
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Flexible attitude, capable to balance multiple priorities;
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Quality conscious attitude;
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Experience and knowledge in the preparation of regulatory submissions;
Contract
Executive search
Experience
minimum 5 years
Education
Master's Degree
Languages
English
Sector
Pharmaceutical industry
Region
Gent
Job type
Full-time
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