Head of Global USP MS&T CoE
Sandoz · Telangana (Sandoz)
Job Description Summary
-Lead the global USP Manufacturing Science & Technology Center of Excellence responsible for technology transfers, process lifecycle management, manufacturing support, validation support, and technical governance across Sandoz manufacturing sites and external partners.-Provide scientific leadership and scalable technical solutions that enable robust manufacturing, uninterrupted supply, regulatory compliance, and operational excellence across the global biologics network.
Job Description
Position Purpose:
Lead the global USP Manufacturing Science & Technology Center of Excellence responsible for technology transfers, process lifecycle management, manufacturing support, validation support, and technical governance across Sandoz manufacturing sites and external partners.
-Provide scientific leadership and scalable technical solutions that enable robust manufacturing, uninterrupted supply, regulatory compliance, and operational excellence across the global biologics network.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
Technical Leadership
- Own technical oversight of upstream manufacturing processes across commercial products.
- Serve as SME for fed-batch, intensified fed-batch, and continuous perfusion upstream process control strategies.
- Lead resolution of complex technical manufacturing issues and investigations.
Innovation & Emerging Technologies
- Continuously evaluate emerging upstream processing technologies, digital solutions, advanced analytics, automation platforms, single-use technologies, and manufacturing innovations for applicability across the biologics network.
- Assess technical feasibility, business value, implementation risks, and potential impact on product quality, process robustness, cost of goods, and supply reliability.
- Develop business cases and implementation roadmaps for adoption of state-of-the-art manufacturing technologies.
- Partner with Manufacturing, Process Development, Engineering, Digital, and external technology providers to pilot and industrialize innovative solutions.
- Drive implementation of approved technologies and ensure effective knowledge transfer across manufacturing sites and CMOs.
- Represent MS&T in external industry forums, scientific conferences, and technology networks to identify emerging best practices and innovation opportunities.
Manufacturing Support
- Ensure timely scientific support for routine manufacturing operations.
- Provide expert support for investigations related to process deviations, atypical results, and process performance excursions to in-house facilities as well as CMOs as needed.
- Support root cause analysis and implementation of effective CAPAs.
Process Lifecycle Management
- Lead continued process verification (CPV) programs across commercial products.
- Support Annual Product Reviews (APR/PQR) and trend evaluations.
- Lead technical risk assessments associated with process changes, deviations, investigations, and technology transfers.
- Support change control assessments and implementation of post-approval manufacturing changes.
- Ensure technical oversight of process validation lifecycle activities.
- Drive robust documentation and knowledge management practices.
Technology Transfer
- Support/lead upstream process scale-up and transfer activities into and out of the site as well as into and out of the External partners.
- Ensure effective transfer of process knowledge, process characterization data, and control strategies.
- Assess technical risks associated with process transfers and scale-up activities.
Validation Activities
- Support PPQ planning, execution, review and closure.
- Support process characterization and validation strategy development.
- Provide technical oversight for validation exceptions and deviations.
- Support ongoing process validation activities throughout the product lifecycle.
- Collaborate with Validation, Quality and Manufacturing organizations to maintain validated state.
- Review and approve validation protocols, reports, and technical documentation.
Continuous Improvement
- Drive initiatives to improve yield, throughput, process capability, and cost efficiency.
- Promote application of advanced analytics, PAT, digital tools, and data-driven process monitoring.
- Identify and implement innovative manufacturing solutions.
People Leadership
- Lead and develop Technical Managers and scientists within the upstream MS&T organization.
- Build technical capabilities and ensure succession planning.
- Foster a culture of scientific excellence, accountability, and continuous improvement.
Key Performance Indicators
Quality & Compliance
- Critical/Major inspection observations
- Recurring deviation rate
- Overdue deviations and CAPAs
- Upstream processes maintained in validated state
Operational Excellence
- Right First Time (RFT) manufacturing
- Upstream process yield achievement
- Upstream process CpK/PpK performance
- Process robustness indicators
Delivery
- Technology transfers delivered OTIF
- Validation/CPV milestones achieved
- Technical investigations completed on time
Continuous Improvement
- Yield/productivity improvement realization
- Successful implementation of process improvements
People
- Employee engagement
- Talent development and succession readiness
- Training compliance
What you’ll bring to the role:
Essential Requirements:
- PhD in Biotechnology, Bioprocess Engineering, or related field (Preferred) / MSc in Biotechnology, Biochemical Engineering, Life Sciences, Chemical Engineering, Pharmaceutical Sciences, or related discipline.
- 10 years experience in Biologics MS&T, Process Development, Technical Operations, or Manufacturing, 3-5 years leadership experience
- Strong expertise in upstream processing and commercial biologics manufacturing
- Experience in technology transfer and process validation
- Experience supporting regulatory inspections.
- Continuous manufacturing experience
- Multi-product commercial manufacturing support
- Advanced process analytics/PAT experience
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 access to good healthcare.
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
Applied Statistics, Applied Statistics, Assembly Language, Back-End Development, Biotechnology, Chemical Engineering, Chemistry, Design Development, Electronic Components, General Hse Knowledge , Incentive Program, Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Leadership, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Npd (New Product Development), Process and Cleaning Validation, Process Control, R&D (Research And Development), Root Cause Analysis (RCA), Software Development, Software Engineering {+ 1 more}