Associate Director, Analytical Separation Sciences

4 settimane fa

Siena, Italia 12371 GSK Vaccines S.r.l. A tempo pieno

Associate Director, Analytical Separation Sciences – Vaccines R&D

Are you excited about taking on a dynamic, high-impact role that involves leading a team of experts (10-15 direct reports based in Italy), collaborating with the Global Separation Sciences team, and contributing to the establishment of a new, global Separation Sciences organization with teams spanning the globe? If so, we invite you to explore this thrilling opportunity.

Job Purpose:

Analytical tools for separation and electrophoresis play a crucial role in the development of candidate vaccines, assessing their quality in terms of safety and potential immunogenicity. These vaccine-specific analytical methods are developed for each new vaccine candidate.

The accountability of the Separation Sciences team extends from innovation through development, qualification & validation, GMP release testing, and concludes with the transfer of analytical methods to commercial QC labs.

Responsibilities:

Lead and shape a team of experts that deliver on promise in method development, validation, process support, and GMP testing whilst promoting an efficient, divers, and innovative working environment.

Foster an enterprise mindset and maximize the efficiency and flexibility potential of the Global Separation Sciences team.

Shape and lead a team that independently designs and executes method development workstreams using best-in-class analytical separation and electrophoresis tools assess quality attributes of candidate vaccines.

Contribute to the growth of a Global Separation Sciences team by aligning on global priorities and portfolio management, harmonizing technical capabilities, development approaches, documentation, resource constraints, and appropriate risk-taking.

Define a phase-appropriate strategy for the development and implementation of testing methods for candidate vaccines covering the early and late phase development and product launch.

Identify risks related to process feasibility, manufacturability, timing, and resource constraints and develop remediation plans. Escalate any technical issues to the Technical Development Team.

Influence project priorities, manage the local portfolio, and encourage smart risk-taking to accelerate vaccine development.

Connect with experts internally in GSK Vaccines and externally with academics to develop state-of-the-art techniques and build a team om best-in-class Subject Matter Experts.

Why You?

The ideal candidate should possess a unique blend of leadership skills, strategic vision, and a wealth of experience in method development.

Demonstrated ability to shape and build high-performing teams, fostering a culture of creativity, accountability, and flexibility in a collaborative and innovative environment.

Exceptional communication and interpersonal skills to effectively motivate, mentor, guide team members and manage stakeholders.

M.S. in Immunology, Chemistry, Biology Sciences, Virology, or similar.

Extensive hands-on experience in method development within the pharmaceutical industry and a solid understanding of regulatory and GMP requirements.

Ph.D. in Analytical Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or similar.

Problem-solving ability with limited information available to make decisions and interpretations. Anticipates medium/long-term future issues.

Superlative presentation skills, across lines and levels and with senior stakeholders.

In-depth knowledge of the latest advancements, technologies, and best practices in method development.

Expert knowledge of advanced separation science technologies like LC, CE, GS, MALS, etc.

Experience in writing regulatory submissions like IND/IMPD/BLA/MAA

Job posting end date: March 15th, 2024

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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