CMC Manager, Nanologica, Södertälje
Search4S Dustgoat AB / Kemistjobb / Södertälje
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Visa alla kemistjobb i Södertälje,
Salem,
Ekerö,
Nykvarn,
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hela Sverige Visa alla jobb hos Search4S Dustgoat AB i Södertälje,
Huddinge,
Sundbyberg,
Stockholm,
Solna eller i
hela Sverige Are you willing to manage all CMC at a drug development and tech company? Would you enjoy a vide variety of responsibilities in an organisation where everyone truly matters? Nanologica has a number of development and manufacturing projects ongoing and upcoming, hence we need you!
At Nanologica we work with nanoporous silica particles for drug delivery and chromatography. Our drug candidate for treatment of gastroparesis is advancing to clinical trials and more products are in the pipeline. As CMC manager your responsibilities include:
Select and manage CMOs for process optimization, cGMP manufacture and supply of IMP
Deliver robust, scalable and cost-effective manufacturing routes
Implement analytical methods and protocols to ensure regulatory compliance of systems and processes
Prepare, review and edit cGMP batch records, CMC regulatory and Quality documents.
Execute plans for the validation and registration of IMP as required by cGMP, ICH and FDA regulations.
Writing and reviewing documents for INDs/regulatory section submissions.
Want to know more? We created a website for this job:
https://search4s.teamtailor.com/pages/nanologica-2019Location: Södertälje Science Park
Terms: Full-time, open-ended (permanent)
StartingDate: As soon as possible or upon agreement
Qualifications
As part of a small company you need to be proactive, take initatives and be ready to take on a variety of tasks. You enjoy a variation of tasks and priorities but can also keep track of long-term goals. You need to like people and to lead them to common goals.
Required qualifications:
Academic degree within chemistry, pharmacology, engineering or similar
Fluent English
Work experience from CMC within pharma and/or biotech
Extensive knowledge of cGMP and GxP
Knowledge of analytical chemistry, validation and formulation
Work experience from CMO/CRO, either as a client or from working at one
Experience from working with IMP
Meriting qualifications (if you have them - great! Otherwise, learn them at Nanologica):
Regulatory applications, e.g. IND, CTA, NDA
Staff management and/or project management
Method validation
Budgets and cost control
Swedish
Is this you? Welcome with your application!
Application
In this recruitment Nanologica collaborates with Search4S,
www.search4s.se.For more information, contact Recruitment Consultant Anna Rennermalm, +46 707 94 20 05,
anna@search4s.se Apply here:
https://search4s.teamtailor.com/jobs/800838-cmc-manager-nanologica-sodertaljeExtra material (e.g. interview with your future manager):
https://search4s.teamtailor.com/pages/nanologica-2019Selection of candidates & interviews will be conducted continuously, thus submit your application as soon as possible.
Last application date: Jan 17 2020
About Nanologica AB (publ)
Nanologica is a Swedish nanotechnology company developing nanoporous silica particles for applications within life science. Nanologica is world-leading in controlling the shape, size and type of porosity of silica particles. This knowledge is applied within two business areas: drug delivery and chromatography. The company's mission is to contribute to better and cheaper treatments for patients worldwide through the technology platform NLAB SilicaTM.
www.nanologica.comPubliceringsdatum2019-12-23Så ansöker duSista dag att ansöka är 2020-01-17
Klicka på denna länk för att göra din ansökanAdressSearch4S Dustgoat AB
Forskargatan 20G
15136 SÖDERTÄLJE
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Search4S Dustgoat AB (org.nr 559065-9297)
Forskargatan 20G (
visa karta)
151 36 SÖDERTÄLJE
Arbetsplats Nanologoca
Jobbnummer 5018463
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