GSK
Director, Head of CMC Early Development and In-Process Analytics, US
GSK, Cambridge, Massachusetts, us, 02140
Director, Head of CMC Early Development and In-Process Analytics US
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.
The CMC Early Development and In-Process Analytics US is a new team that will combine three strategically important groups acting in synergy to successfully transform a vaccine idea into a product:
The Mammalian Expression Technologies Center of Excellence
(MET CoE) focuses on developing high-producing cell lines for CHO recombinant protein-based vaccines and advancing next-generation cell line engineering.
The Nucleic Acid Vaccines Center of Excellence (NAV CoE)
develops cutting-edge mRNA Drug Substance vaccine platforms for rapid development of new vaccine candidates.
A new In-Process Analytical team (IPA)
will support the two Centers of Excellence by developing fit-for-purpose analytical tools to accelerate pre-Ph1 development.
We are seeking a Director to lead the CMC Early Development and In-Process Analytics group, to be based in Cambridge, MA. This senior leader will be responsible for establishing the team at its new Cambridge location, transferring current labs and team members from Rockville, recruiting top-tier scientists, and building a high-performing team to advance vaccine candidates from discovery and pre-clinical phases through the CMC roadmap.
This role will report to the Head of Global Drug Substance and will play a significant role in shaping current and next-generation GSK vaccine platforms to address unmet medical needs.
Key Responsibilities:
Build, lead and integrate a high-performing team : onboard, manage, coach, and develop this newly formed team of leaders.
Strategic planning and collaboration:
design and drive the scientific strategy of both Centers of Excellence and IPA.
Act as a key opinion leader:
think and act strategically to continuously improve and shape the CMC strategy.
Innovation:
implement innovative approaches and ensure relevant stakeholders are onboard.
Cultivate department culture:
maintain excellence in science and operations, fostering a positive culture of transparency and collaboration.
Basic Qualifications:
PhD in Molecular Biology, Biotechnology, Bioengineering, Chemical Engineering or a related scientific field.
5+ years’ experience as a leader of a scientific team in biologics or vaccines Drug Substance development.
Preferred Qualifications:
Industry experience in genome engineering and development of mammalian cell lines.
Knowledge of regulatory vaccine landscape FDA/ICH/ISPE.
Excellent communication skills, with capability to influence senior leaders.
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At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.
The CMC Early Development and In-Process Analytics US is a new team that will combine three strategically important groups acting in synergy to successfully transform a vaccine idea into a product:
The Mammalian Expression Technologies Center of Excellence
(MET CoE) focuses on developing high-producing cell lines for CHO recombinant protein-based vaccines and advancing next-generation cell line engineering.
The Nucleic Acid Vaccines Center of Excellence (NAV CoE)
develops cutting-edge mRNA Drug Substance vaccine platforms for rapid development of new vaccine candidates.
A new In-Process Analytical team (IPA)
will support the two Centers of Excellence by developing fit-for-purpose analytical tools to accelerate pre-Ph1 development.
We are seeking a Director to lead the CMC Early Development and In-Process Analytics group, to be based in Cambridge, MA. This senior leader will be responsible for establishing the team at its new Cambridge location, transferring current labs and team members from Rockville, recruiting top-tier scientists, and building a high-performing team to advance vaccine candidates from discovery and pre-clinical phases through the CMC roadmap.
This role will report to the Head of Global Drug Substance and will play a significant role in shaping current and next-generation GSK vaccine platforms to address unmet medical needs.
Key Responsibilities:
Build, lead and integrate a high-performing team : onboard, manage, coach, and develop this newly formed team of leaders.
Strategic planning and collaboration:
design and drive the scientific strategy of both Centers of Excellence and IPA.
Act as a key opinion leader:
think and act strategically to continuously improve and shape the CMC strategy.
Innovation:
implement innovative approaches and ensure relevant stakeholders are onboard.
Cultivate department culture:
maintain excellence in science and operations, fostering a positive culture of transparency and collaboration.
Basic Qualifications:
PhD in Molecular Biology, Biotechnology, Bioengineering, Chemical Engineering or a related scientific field.
5+ years’ experience as a leader of a scientific team in biologics or vaccines Drug Substance development.
Preferred Qualifications:
Industry experience in genome engineering and development of mammalian cell lines.
Knowledge of regulatory vaccine landscape FDA/ICH/ISPE.
Excellent communication skills, with capability to influence senior leaders.
#J-18808-Ljbffr