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The Associate Director of In-Process-Analytics, Drug Substance Italy Siena will lead a team of experts that support Drug Substance process development for all vaccine projects (antigens) under the responsibility of the Italy Siena TRD Drug Substance organizations. The selected AD of In-Process-Analytics will report to the Head of the US/IT Early development and In-process analytics group.

The AD of In-Process-Analytics Drug Substance Italy Siena will lead a team of experts dedicated to supporting Drug Substance process development across various vaccines programs. This position is crucial for maintaining the highest level of analytical rigor and efficiency within the Italy Siena TRD Drug Substance organization and, more in general, fostering collaboration within the global Drug Substance network. The successful candidate will drive the advancement of in-process analytics within the organization, ensuring alignment with QbD principles and fostering a deep understanding of the interface between product and process.

The scope of the Italy Siena In-Process Analytics organization is three-fold:

              1. Develop Fit-for-Purpose Methods: Create tailored methods and assays that support process development, enabling precise process design selection and thorough process evaluation and characterization.

              2. Enhance In-Process-Analytical Capabilities: Build, refine, and scale the organization’s in-process-analytical capabilities for vaccine development in alignment with QbD principles, fostering a deeper and broader understanding of the interactions and interfaces between product and process.

              3. Support and Organize Routine Analyses: Facilitate the transfer and organization of routine analyses for established in-process methods applicable to the Italy Siena Drug Substance development units, ensuring readiness for advanced projects as dictated by vaccine development needs.

Your responsibilities:

• Team Leadership and Development: Lead and develop your team towards achieving excellence in in-process analytics, enabling Drug Substance and the broader TRD organization to reduce time-to-market, improve profitability, and enhance product robustness.

• Innovative Analytical Methods: Develop in-process analytical methods using advanced technological platforms (e.g., immunoassays, liquid chromatography, light scattering, mass spectrometry, spectroscopies, …) for a wide array of processes including fermentation, cell culture, purification, and antigen generation (e.g., recombinant proteins, glycoproteins, glyco-conjugates).

• Comprehensive Analysis: Utilize analytical methods for (1) antigen characterization and quantification, (2) product and process-related impurities identification and quantification, and (3) process performance characterization.

• Analytical Platform Development: Develop and consolidate in-process analytical platforms for faster and deeper understanding of antigens throughout development, supporting process and product development more efficiently.

• High-Throughput Capabilities: Develop high-throughput analytical capabilities essential for integrated support in high-throughput upstream, midstream, and downstream Drug Substance development in both dedicated and large-scale high-throughput labs.

• Collaboration and Innovation: Collaborate closely with your team and PAT subject matter experts in the Drug Substance network to enhance process control and monitoring. Work with internal and external industry trends to ensure the latest practices are integrated into your workflows.

• Partnerships and Networking: Establish and maintain key partnerships with the analytical R&D organization to leverage specialized expertise and capabilities, ensuring the highest standards in various development projects within the most effective timeframes.

• Engage in Stakeholder Collaboration: Build strong relationships with in-process analytics groups within the Global DS organization to share knowledge, stimulate innovation, and drive the adoption of advanced technologies across the network.

• Holistic Approach to Development: Align with the Technical R&D Drug Product, Preclinical, Manufacturing Science and Technology, and Commercial Manufacturing organizations to ensure cohesive and comprehensive in-process analytical strategies.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Master’s degree in bioengineering, biochemistry, biotechnology, chemistry, or a related field

• Strong experience in Biopharmaceuticals or Vaccines development.

• Good experience in analytical development, in-process analytics, or a related area.

• Thorough understanding of bioprocess development, Quality by Design, PAT, method qualification, and assay (performance) characterization.

• Ability to thrive in a multidisciplinary environment, adept at working with various technologies (e.g., immunoassays, liquid chromatography, LC-MS, light scattering, spectroscopies).

• Excel at leading a team, developing people, setting direction, focusing on priorities, and inspiring the organization is what you like and are good at.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• PhD in bioengineering, biochemistry, biotechnology, chemistry, or a related field

• Your interpersonal skills allow you to engage effectively with stakeholders both inside and outside your organization.

• Communication is one of your strengths.

• Unstoppable drive for excellence.

What We Offer

• Permanent contract in a very Inclusive environment

• Smart Working up to 50% for eligible roles

• Flexible Benefits

• Company Healthcare Plan

• Integrative pension fund

• Employee Assistance Programme

• Prevention services and vaccination clinic

• Tax assistance

• Local nursery agreement

• Postal service, laundry, shoe repair and tailoring

• On Site Gym

• On Site canteens and bars

• Free company bikes and shuttle

• Performance Reward

Closing Date for Applications – October 6th, 2024

Please take a copy of the Job Description, as this will not be available post closure of the advert. 
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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