Senior Manager, Global Head of Pharmaceutical Technical Sciences

Senior Manager, Global Head of Pharmaceutical Technical Sciences
+ Requisition ID:WD90033
+ Position:Full time
+ Open date:Sep 13, 2016 11:53 AM
+ Functional area:Science and Technology
+ Location:Maryland
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+ + Required degrees:Phd/Doctorate
+ Experience required:10 years
+ Relocation:Yes
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Basic qualifications:-- PhD in Pharmaceutical Sciences or a closely related discipline, with 10 years of experience in a formulation team with a focus on vaccines or recombinant proteins.
-- Proven experience managing a team
-- Excellent organizational and communications skills,
Negotiation and influencing skills.
-- Ability to work and lead in a in a highly collaborative multi-cultural environment.
-- Experience with novel adjuvants and nucleic acids would be highly valued.
Preferred qualifications:Same.
Details:The Global Head of Pharmaceutical Technical Sciences is responsible for establishing and maintaining the appropriate level of pharmaceutical technical sciences and formulation expertise at each of the 3 global RDC sites in US, Belgium and Italy. He or she will serve as the lead scientist for ensuring smooth and effective transfer of Drug Product into later stage development, including oversight on all data, documents and supporting evidences.
On behalf of TRD, the role will build and lead the interface between the research groups at RDCs, both directly and in collaboration with TRD heads. The position will ensure that consideration for industrialization of proposed antigen workstream and novel adjuvant candidates are accounted for early in development, in order to improve efficiency and ultimately product robustness. Additionally, he or she will provide pre-formulation information which informs preclinical formulation, the choice of potential delivery systems, and is the scientific basis for successful product development.
The position must establish and maintain strong collaboration and interaction both locally and globally with internal and external partners and contribute to project plans for delivering the CMC strategy and Project objectives. The role also ensures that the content and quality of regulatory submissions, both nonclinical and CMC modules, meet requirements in all markets.
He or she will be responsible for recruiting, coaching and leading a high performance team in the US, as well as leading QbD locally for the team, within the global initiative and helping to define the CQA in all pre-clinical projects/platforms.
Contact information:
You may apply for this position online by selecting the Apply now button.
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