Study Manager Manufacturing *NEW*The Nanobody® contract manufacture group is looking for a highly motivated (senior) scientist to strengthen the team. The successful candidate is expected to make an active contribution in the day to day management of outsourced process development and manufacturing activities to support supply of Nanobody® development candidates for use in toxicological and early clinical trials.
Responsibilities
* Converts Ablynx’ project goals (Tox, cGMP-material, stability studies, IMPD-filing at pre-defined milestones) into action plans, followed by implementation
* Coordinates project work with external contract manufacturing organizations (CMO’s), creates a collaborative team environment to solve problems, build consensus, proactively implement solutions and acts as the key contact for the third party contractors
* Provides the appropriate technical and organizational support to ensure an efficient execution of internal CMC-development activities, technology transfer and further activities at the CMO, assuring quality and timelines
* Reports about the results and progress to the project team and section head manufacturing, and contributes to the project strategy
* Plays a cross-departmental (e.g. for Legal and Business development, QA&QC, Regulatory Affairs, Clinical Operations) advisory, consultancy role regarding the CMO activities to assists in a.o. CMO –screening/selection, contract negotiations and IMPD filing
* Ensures that appropriate data and documentation is in-place for in-time successful IMPD-filing and assists with high-level document, manuscript preparation and review.
Profile
The candidate should:
* Hold a PhD. in Biology, Biotechnology, (Bio)Chemistry, Pharmacology or equivalent for at least 5 years, with a minimum of 2 years relevant experience in business or scientist position
* Have a sound knowledge of molecular biology, upstream & downstream processing and analytical biochemistry
* Have significant experience in the application and development of cGMP production processes and accompanying regulatory and quality requirements
* Be able to work independently within the scope of his/her assigned field
* Have excellent communication skills (fluent in English, written and spoken)
* Demonstrate proven organizational and coordination skills
* Have sense for initiative, quality, accuracy and detail
* Be able to deal with significant responsibilities and is stress-resistant
* Be a team player, enthusiastic and flexible
Please enter your details and upload your CV and motivation letter:
-Your CV should include a paragraph specifying the technical expertise.
-Please describe your expectations of the position in your motivation letter
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