Tech associate USP MS&T CoE

Sandoz India; Telangana; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sandoz India is seeking a highly skilled USP SME responsible for technology transfers, process lifecycle management, manufacturing support, validation support, and technical governance across Sandoz manufacturing sites and external partners. The role focuses on upstream operations for biologics and continuous improvement.

You will drive CPV, APR/PQR inputs, change control, CAPAs, and knowledge transfer, partnering with multiple functions to ensure product quality, supply reliability, and

Qualifications

• MSc in biotechnology or related field required.
• Min 3+ years experience in Biologics MS&T, Process Development, Technical Operations, or Manufacturing.
• Experience supporting commercial manufacturing. Experience investigating process deviations and implementing CAPAs.
• Good understanding of GMP requirement.
• Experience with technology transfer and process validation.
• Experience with perfusion or continuous manufacturing operations.
• Experience in scale up and scale down of USP, Experience with single use technology operations.

Responsibilities

• Provide technical support for Upstream manufacturing processes across commercial products.
• Serve as SME for fed-batch, intensified fed-batch, and continuous perfusion upstream process control strategies.
• Support resolution of complex technical manufacturing issues and investigations.
• Evaluate emerging upstream processing technologies and digital solutions for applicability across the biologics network.
• Partner with Manufacturing, Process Development, Engineering, Digital, and external technology providers to pilot and industrialize innovative solutions.
• Support implementation of approved technologies and ensure effective knowledge transfer across sites and CMOs.
• Ensure timely scientific support for routine manufacturing operations.
• Provide support 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.
• Perform continued process verification (CPV) programs across commercial products.
• Support Annual Product Reviews (APR/PQR) and trend evaluations.
• Support technical risk assessments associated with process changes, deviations, investigations, and technology transfers.
• Support change control assessments and implementation of post-approval manufacturing changes.
• Drive robust documentation and knowledge management practices.
• Support Upstream process scale-up and transfer activities and documentation into and out of the site as well as into and out of the External partners.

Skills

Upstream domain expertise

Execution Excellence

Scientific Problem Solving

Collaboration

Continuous Improvement

Quality Mindset

Results Orientation

Education

MSc in Biotechnology, Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, Life Sciences, or related discipline

Job description

Position PurposeAs USP SMEs, responsible for technology transfers, process lifecycle management, manufacturing support, validation support, and technical governance across Sandoz manufacturing sites and external partners.

Position PurposeAs USP SMEs, responsible for technology transfers, process lifecycle management, manufacturing support, and technical governance across Sandoz manufacturing sites and external partners.

Your Key ResponsibilitiesYour responsibilities include, but not limited to:

Technical support

• To provide support Upstream manufacturing processes across commercial products.
• Serve as SME for fed-batch, intensified fed-batch, and continuous perfusion upstream process control strategies.
• Support resolution of complex technical manufacturing issues and investigations.

Innovation & Emerging Technologies

• 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.
• Partner with Manufacturing, Process Development, Engineering, Digital, and external technology providers to pilot and industrialize innovative solutions.
• Support implementation of approved technologies and ensure effective knowledge transfer across manufacturing sites and CMOs.

Manufacturing Support

• Ensure timely scientific support for routine manufacturing operations.
• Provide support 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

• Perform continued process verification (CPV) programs across commercial products.
• Support Annual Product Reviews (APR/PQR) and trend evaluations.
• Support technical risk assessments associated with process changes, deviations, investigations, and technology transfers.
• Support change control assessments and implementation of post-approval manufacturing changes.
• Drive robust documentation and knowledge management practices.

Technology Transfer

• Support Upstream process scale-up and transfer activities and documentation 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 and author documents 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 documentation support for validation exceptions and deviations.
• Support ongoing process validation activities throughout the product lifecycle.
• Author validation protocols, reports, and technical documentation.

Continuous Improvement

• Support initiatives to improve yield, throughput, process capability, and cost efficiency.
• Identify and implement innovative manufacturing solutions.

Competencies

• Upstream domain expertise
• Execution Excellence
• Scientific Problem Solving
• Collaboration
• Continuous Improvement
• Quality Mindset
• Results Orientation

Essential Requirements What you’ll bring to the role:

• MSc in Biotechnology, Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, Life Sciences, or related discipline
• Min 3+ years experience in Biologics MS&T, Process Development, Technical Operations, or Manufacturing
• Experience supporting commercial manufacturing. Experience investigating process deviations and implementing CAPAs
• Good understanding of GMP requirement
• Experience with technology transfer and process validation
• Experience with perfusion or continuous manufacturing operations
• Experience in scale up and scale down of USP, Experience with single use technology operations

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 & InclusionWe are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.