Job Description Summary
The MS&T Associate provides technical expertise and documentation support to Site MS&T across the product lifecycle, supporting feasibility studies, process validation and cleaning validation, SOPs, and lifecycle management activities. The role contributes to maintaining a continued state of validation and process robustness through science and risk based approaches.This position supports critical and strategic initiatives by developing risk assessments, QbD based design documents, and technical justifications, ensuring timely and compliant project execution across global manufacturing and external sites. The MS&T Associate ensures effective knowledge sharing and provides second line technical support to manufacturing and quality teams
Job Description
Position Purpose:
The MS&T Associate provides technical expertise and documentation support to Site MS&T across the product lifecycle, supporting feasibility studies, process validation and cleaning validation, SOPs, and lifecycle management activities. The role contributes to maintaining a continued state of validation and process robustness through science and risk-based approaches.
This position supports critical and strategic initiatives by developing risk assessments, QbD based design documents, and technical justifications, ensuring timely and compliant project execution across global manufacturing and external sites. The MS&T Associate ensures effective knowledge sharing and provides second line technical support to manufacturing and quality teams.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
- Technical & Process Lifecycle Documentation Support: Support Site MS&T and Technical Experts by managing and maintaining comprehensive technical documentation for assigned products across the commercial lifecycle. Act as a central point of contact for MS&T documentation, ensuring accuracy, consistency, and traceability of product and process knowledge.
- Data Trending & Process Monitoring Documentation: Prepare and maintain documentation inputs for APQR, Ongoing Process Verification (OPV), and product state‑of‑control assessments. Ensure timely preparation, review coordination, approval, and archival of protocols, reports, risk assessments, and project‑related technical documents. Ensure process performance data and analyses are clearly documented and readily available for technical and regulatory reviews. Support collection, compilation, and documentation of process data, statistical trending, and analysis of critical and key process variables.
- Risk Management & QbD Documentation: Support preparation, updating, and lifecycle management of product‑specific Quality Risk Assessments (QRAs), covering IPCs, CQAs, CPPs, and CMAs. Compile and maintain QbD‑based design documents, control strategies, and risk assessment documentation for technical changes and improvement initiatives
- Validation & Lifecycle Documentation Compliance: Support maintenance of a continued state of validation by preparing, updating, and managing process, cleaning, and OPV documentation. Coordinate execution, review, approval, and closure of validation protocols and reports in collaboration with Validation, Quality, and Site MS&T. Coordinate with QC and stability functions to ensure documentation readiness for sample planning and validation activities.
- Technical Change & Investigation Documentation Support: Support technical change activities by preparing impact assessment documentation, risk evaluations, and technical justification records. Support root‑cause investigations, CAPA documentation, and product or process improvement records under guidance of the Technical Steward or MS&T Lead.
- Launch, Transfer & Cross‑Site Documentation Support: Support product launches and transfers by compiling structured technical data packages and supporting documentation. Facilitate effective documentation‑based knowledge exchange across functions, global manufacturing sites, and external partner
- Operational Excellence & Inspection Readiness: Ensure sustained inspection readiness through compliant, complete, and timely MS&T documentation aligned with global and site requirements. Support manufacturing robustness, optimization, and OpEx initiatives through structured documentation and data compilation.
What you’ll bring to the role:
Essential Requirements:
- BSc. in Pharmacy, B. Pharma, Pharmaceutical Technology, Chemistry or equivalent scientific degree..
- Minimum 4-8 year experience in Process support, Documentation and Lab and Shopfloor experience of pharmaceutical manufacturing.
- Proven process understanding (Pharma, GMP, Regulatory aspects).
- Sound experience of data handling and applied statistics is a must.
Why Sandoz?
Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!
Join us, help us make healthcare fairer and faster.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Assembly Language, Change Control, Chemical Engineering, Chemistry, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge , Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Pharmaceutics, Process and Cleaning Validation, Process Control, Process Engineering, Risk Management, Root Cause Analysis (RCA), Scheduler, Six Sigma, Sop (Standard Operating Procedure)Skills Required
- BSc in Pharmacy, B. Pharma, Pharmaceutical Technology, Chemistry or equivalent scientific degree
- Minimum 4-8 years experience in process support, documentation, lab and shopfloor pharmaceutical manufacturing
- Proven process understanding including GMP and regulatory aspects
- Experience in data handling and applied statistics
- Experience with process validation and cleaning validation
- Experience preparing and maintaining SOPs, validation protocols, reports, and technical documentation
- Experience with Quality by Design (QbD), risk assessments, and control strategy documents
- Knowledge of CAPA and root cause analysis
- Familiarity with continual improvement tools (Lean, Six Sigma) and change control processes
Sandoz Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sandoz and has not been reviewed or approved by Sandoz.
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Healthcare Strength — Health, dental, vision, and prescription coverage are consistently described as core components across U.S. roles and materials. Feedback suggests the medical offering is broad and a standard pillar of the package.
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Retirement Support — A 401(k) plan with a company match described as generous is commonly included for U.S. roles. This savings support is positioned alongside other primary benefits as part of total rewards.
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Equity Value & Accessibility — Equity eligibility is noted for many positions and a global all‑employee share program is being introduced from 2026. These elements add upside beyond base salary and annual bonus.
Sandoz Insights
What We Do
Sandoz is the global leader in generic and biosimilar medicines. Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance. We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.
