CMC Technical Project Leader Biologics
AstraZeneca / Biologjobb / Göteborg
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hela Sverige Are you an expert in biological pharmaceuticals and bioprocessing with experience in biologics chemistry, manufacturing and control (CMC)? Are you aiming for a role where you will provide scientific leadership within your discipline? Would you like to apply your expertise in a company that are following the science and turn ideas into life changing medicines? Then you might be the one we are looking for!
AstraZeneca is now looking to recruit a CMC Technical Project Leader with speciality in Biological pharmaceuticals/Biologics and Bioprocessing to join the Early Chemical Development (ECD) function within Pharmaceutical Sciences at AstraZeneca. Preferred location is Gothenburg (Sweden) but the position can also be placed in Macclesfield (UK) or Cambridge (UK).
Pharmaceutical Sciences is part of the Innovative Medicines and Early Development (IMED) organisation in AstraZeneca. Our role is to design and implement the drug substance, drug product and delivery components for our new medicines across all the AZ therapy areas from early discovery to Phase llB clinical trials. Within Pharmaceutical Sciences, Early Chemical Development is responsible for developing manufacturing routes and processes, and delivering batches of drug substance, for all projects in the late discovery and early development portfolio. A large part of the portfolio is focussed on small molecules, but an important and growing area focusses on non-small molecules drug ranging from oligonucleotides and peptides to New Modality projects including antibody drug conjugates and dendrimer drug conjugates.
More recently, a number of biological molecules (proteins, fusion proteins and monoclonal antibodies) have entered the portfolio, and we are seeking a CMC Technical Project Leader Biologics to provide the necessary technical insight and leadership for development and scaling up of biological processes for biological pharmaceuticals.
Main Duties and Responsibilities
As the Technical Project Leader Biologics in ECD, you will be responsible for providing technical leadership for our range of biologics projects from pre-nomination to Phase II, establishing and developing manufacturing processes and analytical methods, and delivering batches of drug substance. This work is conducted in partnership with a number of strategic collaborators, and is undertaken externally at a range of Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs).
You will utilise your expertise to deliver the biologics projects, ensuring that appropriate standards and targets are met. You will also look to deliver new science and ways of working to improve project deliveries, driving innovation and engaging internal and external expertise.
You will be expected to form a network with experts in other departments in AstraZeneca and develop a strong scientific community.
As a senior expert in the organisation you will provide scientific leadership to the organisation, for example acting as a role model and providing coaching and support in areas such as scientific standards and collaborations. You will also contribute to the wider scientific and business strategy for the department.
Essential Requirements
You will be an expert in the development and manufacture of biological molecules, with a MSc/PhD or equivalent in biochemical engineering, biochemistry, biology or related discipline and a minimum of 5 years of experience.
You have relevant biologics CMC (chemistry, manufacturing and control) experience in an industrial setting, including extensive experience working with external CROs and CMOs, with a track record of successfully delivered projects. Also, knowledge of current GMP guidelines and familiarity with regulatory authority submissions (IMPD/IND/BLA) is required.
You will also have the following skills and experience:
* Line of sight & preferably knowledge of the overall drug development process from Discovery through to Launch
* Ability to provide technical management of a complex portfolio of projects
*
Detailed understanding of Biologics Upstream and Downstream Processing, including cell line selection, cell harvesting, capture steps, chromatography, process optimisation, scale-up and validation
* Detailed understanding of required analytical techniques including development, optimization and validation
* Ability to lead and actively contribute to globally regulatory submissions of projects for Ph I and Ph II
* Experience in assembling Request for Proposals (RFPs ) in collaboration with other functional leads; CMO identification; developing technical/quality agreements in collaboration with QA
* Experience of Technical Transfer of projects (process and analytical)
* A track record as a scientific leader, providing scientific challenge and driving innovation
If you are interested, apply now!
For more information please contact Jeremy Parker on
Welcome with your application no later than June 24, 2018.
AstraZeneca is a global, science-driven biopharmaceutical company. We turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. AstraZeneca is an equal opportunity employer.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-05-31ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-06-21
Ange följande referens när du ansöker: R-026798
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
ulrica.marklund1@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 4178597
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