Scientific Leader, In-Process Analytics

Site Name: Italy - Siena
Posted Date: Oct 10 2024
We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
The Scientific Leader 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 Scientific Leader of In-Process-Analytics will report to the Head of the US/IT Early development and In-process analytics group.
The Scientific Leader 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:
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.
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.
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: 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.
Preferred Qualifications: 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 OfferPermanent 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
On Site Gym
On Site canteens and bars
Free company bikes and shuttle
Performance Reward
Closing Date for Applications – October 17th, 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 focused on preventing and treating disease with vaccines, specialty and general medicines.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
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.

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