Switzerland, Basel-City, Basel Headquarter
Germany, Bavaria, Penzberg
United States of America, California, South San Francisco
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Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide.
"Global Technical Development" (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate of the group is, to expertly deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does.
As the Analytical Lead you are part of the Pharma Technical - individualized NeoAntigen Specific Therapy team (iNeST). More specifically you will be part of a dedicated cross-functional team working on the development and manufacture of an mRNA based per patient therapy working very closely with our external partner BioNTech.
In this position you provide analytical oversight and expertise to ensure an appropriate control strategy and relevant analytical methods are defined, developed and implemented from early development through product licensure.
In this challenging role you will:
Drive scientific innovative effort to identify, implement and defend a novel control strategy for the overall PCV program to enable high quality control (QC) throughput and minimum turnaround time for product release
Be accountable for method selection, development and validation strategies and transfer
Develop, execute and defend phase appropriate strategies for method validation and specification setting
Develop and defend strategies for product submission and CQA assessments including development and selection of characterization assays
Provide technical and quality control input during the review and approval of applicable documents
Collaborate and/or author sections of documents to be reviewed by health authorities (e.g. Briefing Package, INDa, IMPDa, BLA, etc.)
Support QC sites during method related investigations/root cause analysis
Your Profile
You bring a PhD, Bachelor or Master degree (preferably in Life Science) and 10 to15 years relevant experience in the pharmaceutical industry within the analytical development and QC functions, preferably with experience in the field of RNA therapeutic product. Deep understanding of current industry practices and global regulatory guidelines and experience with health authority interactions is desired.
You bring the following qualifications and competencies:
Strong leadership and teamwork skills
Excellent influencing-without-authority and negotiating skills when interacting with internal and external stakeholders
High flexibility and strong problem solving capacities to meet business objectives and a ‘can-do’ attitude with the ability to deal with ambiguity and to “think out of the box” to challenge the status quo
Proven track record when it comes to strategic prioritization, innovative thinking, effective decision-making, and performance
Strong verbal and written communication skills including the ability to present scientific results and strategic objectives clearly and concisely
German language proficiencies (verbal and written) is a plus
This position requires up to 20% international travel and can be based out of Germany or Switzerland or the U.S.
If you still have questions then please check our FAQs and videos on careers.roche.ch/faq