Brussels ** Sr Scientist / Consultant USP Development ** Key role in an important mAbs program lauch
- Experience Level
Brussels *** Sr Scientist / Consultant USP Development *** Key role in an important mAbs program launch
This is a 9-month contract with a possibility of extension, based in Brussels.
We are seeking a Sr Scientist Upstream Process Development to work on launching one of the most exciting immunology programs in the industry.
Our client is a global biopharmaceutical company that has been investing heavily over the years in R&D and have an impressive pipeline of products. They are now looking for an experienced consultant to help them launch on of their programs.
You will use your proven experience and track record to proactively conceptualize, establish and lead the execution of al the upstream studies required to define the upstream process control strategy. You will enable the successful upstream process design and qualification for an important immunology therapeutic and will work closely with internal and external partners to ensure the development, execution and appropriate documentation of all the scientific studies that enable a comprehensive master validation plan, and subsequent execution of process performance qualification runs ant a CMO.
- Actively participates to the definition of the control strategy of the upstream process.
- Develops, authors, reviews and approves necessary documentation, including requirements specifications, risk assessments, validation plans and the required installation, operational and performance qualifications, protocols and reports that will lead to the definition of the control strategy and / or are supportive of regulatory filings, in compliance with our quality manual.
- Develops project’s plans and verifies alignment with management.
- Monitors and reports to management with project updates.
- Uses her/his engineering and/or scientific background to understand the technical aspects and ensure the success of process scale up and technical transfer to internal and external commercial manufacturing facilities (ex: bioreactors operating parameters: aeration and agitation strategies).
- Serves as process sciences leader and subject matter expert to solve manufacturing challenges, implement long term changes that provide process and/or product improvements, support for investigations, pre and post-launch process enhancements, technology transfers and the development and characterization of next generation processes post-approval.
- Prepares sections of regulatory submissions when required up to and including biological license application and lifecycle support.
- A minimum of a Master's Degree in a scientific or engineering discipline is required.
- A minimum of 6 years of experience in the pharmaceutical industry is required.
- A thorough understanding of biologics drug substance process development, characterization and validation of processes at manufacturing sites is needed.
- Experience with late stage regulatory filings and with the establishment and filing of a drug substance’s control strategy is required.
- Excellent written and oral communication skills in English.
- Experience in authoring relevant sections of BLAs is highly desired.
Proven track record of drug substance commercialization and manufacturing science & technology, technology transfer expertise for monoclonal antibodies is preferred.
If you wish to apply for this role, please send your CV with a covering note to firstname.lastname@example.org or alternatively, to have a confidential discussion about this or other potential roles or career options, call Oli or Matt in the London office on +44 (0)20 7801 3388 or +44 (0)20 7801 3380.
About Advanced Search & Our Network
Advanced Search, has a network of affiliated companies including ADV Regulatory, and ADV Talent Partners. Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005.
Our team know our subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels.
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All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-/pharmaceutical community.
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