Associate Director Process Design and Advanced Analytics

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.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

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 programs that advance process understanding, robustness, and optimization 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 programs generate actionable insights that enable robust and scalable manufacturing processes.

Operating at the intersection of scientific rigor, cross-functional influence, and organizational 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 programs 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 modeling, and data-driven analytics to accelerate insight generation and support continuous improvement across the organization.

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 rigor 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 modeling, 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 organizational 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 program 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 optimizations

• 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 characterization

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 rigor, 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 optimization

• 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 centers

Why you?

Qualifications & Skills:

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

Preferred Qualifications & Skills:

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

• Demonstrated experience designing and interpreting process characterization 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 programs.

• 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 modeling, 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

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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Should you require any specific adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on ita-inclusion.recruitment@gsk.com.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, 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.

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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/