Associate Director Process Design and Advanced Analytics

Site Name: Italy - Rosia Posted Date: Apr 10 2026 Scope The Associate Director, MSAT Scientific Process Design is a senior technical leader and strategic driver within the Process Science function of Global MSAT. This role is responsible for the end‑to‑end design, coordination, and scientific oversight of complex experimental programmes that advance process understanding, robustness, and optimisation across the manufacturing lifecycle — from development through commercial operations. This role sits at the intersection of process science, experimental design, advanced analytics, and manufacturing strategy, ensuring that experimental programmes generate actionable insights that enable robust and scalable manufacturing processes. Operating at the intersection of scientific rigor, cross‑functional influence, and organisational strategy, the Associate Director combines deep expertise in Quality by Design (QbD), process characterization, and statistical methodology with a proven ability to deliver lifecycle management and technology transfer programmes at scale. Rather than conducting day‑to‑day laboratory work, this role shapes and governs the scientific direction of experimental portfolios, partnering with internal and external stakeholders to ensure studies are fit‑for‑purpose, regulatory‑compliant, and designed to generate actionable knowledge. As a leader and technical authority, the Associate Director will contribute to strategic technical roadmaps, capability‑building initiatives, and the integration of advanced tools such as PAT, mechanistic modelling, and data‑driven analytics to accelerate insight generation and support continuous improvement across the organisation. The role will act also as deputy of the Director of the Process Science if/when needed. In this role you will: Process Design & Scientific Leadership Design and oversee statistically sound experimental studies (DoE, robustness testing, screening studies) to support process development, characterization, and implementation of new manufacturing process steps; ensure scientific rigour by challenging statistical and analytical strategies across studies while accounting for production facility capabilities, constraints, and compliance with global guidelines and regulations. Apply and champion advanced process analytics, including Process Analytical Technology (PAT), multivariate data analysis, and mechanistic modelling, to accelerate insight generation and support continuous process improvement. Lead and manage complex technical project activities including planning, timeline definition, risk tracking, budget oversight, and stakeholder coordination — ensuring alignment with project goals and organisational priorities. Author, review, and approve technical protocols, reports, manufacturing support documents, and regulatory source documents (IND, BLA, comparability packages) in support of various project stages and submission readiness. Provide scientific and strategic direction for the full experimental cycle — from study design through data analysis to regulatory documentation — ensuring each programme generates actionable, evidence‑based conclusions. Deepen process knowledge by systematically exploring physical‑chemical and engineering relationships between development‑scale models and full‑scale manufacturing; investigate and propose evidence‑based process optimisations. Collaborate with analytical teams to ensure robust, reliable, and fit‑for‑purpose measurement systems; challenge analytical method definition and qualification to ensure suitability for process characterisation. Scientific Execution Oversight Provide oversight of laboratory study execution in alignment with approved protocols and experimental designs, ensuring adherence to timelines and data quality standards. Identify and troubleshoot operational or technical issues that may impact study outcomes; promote a culture of scientific rigour, data integrity, and operational excellence within the team. Innovation & Digital Technologies Act as a technical lead in identifying and evaluating emerging technologies (e.g., machine learning, digital twins, IoT‑enabled process monitoring) that can enhance manufacturing process efficiency, robustness, and scalability. Collaborate across Engineering, IT, Data Science, Manufacturing, and Quality to deploy scalable, data‑driven solutions; convert complex process data into actionable insights that drive continuous optimisation. Foster academic and external collaborations to access innovative technology platforms and support the broader MSAT Process Science innovation agenda, including partnerships with Pharma R&D, universities, and external research centres. Qualifications & Skills Master’s degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or another relevant scientific discipline; PhD is considered a plus. 6+ years of experience in Tech Transfer, modelling, and managing scale‑up and scale‑down activities. Expertise in biologics or CAR‑T, drug product, or vaccine manufacturing processes (upstream, downstream, or cell & gene therapy). Strong mastery of Quality by Design (QbD) principles and CQA/CPP relationships. Hands‑on experience authoring and/or reviewing regulatory filings: IND, BLA, comparability reports, PPQ documentation. Knowledge of Process Analytical Technology (PAT) tools and implementation strategies. Proven track record of leading complex, multi‑site technical programmes in GMP‑regulated environment. Demonstrated ability to manage timelines, budgets, and resource allocation at a strategic level. Fluent English (essential); additional languages (e.g., Italian or French) advantageous for international site collaboration. Preferred Qualifications & Skills Demonstrated experience designing and interpreting process characterisation studies per ICH Q8/Q9/Q10. Proven track‑record in lifecycle management, continuous process verification (CPV), and technology transfer — including Phase I/II/III and commercial manufacturing programmes. Thorough understanding of global regulatory expectations for process validation, lifecycle management, and submission readiness. Experience providing technical oversight and SME support to CMOs for externally manufactured products. Experience with mechanistic modelling, digital twins, or process simulation — highly valued. Ability to partner with analytical teams to design meaningful test plans and interpret data holistically; solid understanding of assay variability, method suitability, and comparability approaches. Experience managing staff, conducting appraisals, and developing scientific talent. Strong collaboration skills across process development, manufacturing, quality, and regulatory functions. Comfortably influencing senior leadership and presenting technical strategies at governance forums. Excellent written and verbal communication skills with proven ability to produce high‑quality technical documentation. Cross‑cultural sensitivity and experience working in international, hybrid environments. Critical thinking, emotional intelligence, and ability to synthesize complex scientific and operational considerations into coherent strategies. Proactive, innovative mindset with a passion for emerging technologies and continuous improvement. What We Offer Permanent contract in a very Inclusive environment 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 canteens and coffee corners Free company bikes and shuttle Closing Date for Applications – 24th of April 2026 GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. #J-18808-Ljbffr