Job Description Summary

As DSP SMEs, responsible for technology transfers, process lifecycle management, manufacturing support, validation support, and technical governance across Sandoz manufacturing sites and external partners

Job Description

Position Purpose:

As DSP SMEs, responsible for technology transfers, process lifecycle management, manufacturing support, validation support, and technical governance across Sandoz manufacturing sites and external partners

Your Key Responsibilities:

Your responsibilities include, but not limited to:

Technical support

• To provide support Downstream manufacturing processes across commercial products.
• Serve as SME for clarification, batch and continuous chromatography, filtration, UF/DF, SPTFF, and downstream process control strategies.
• Lead/support resolution of complex technical manufacturing issues and investigations.

Innovation & Emerging Technologies

• Evaluate emerging downstream 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 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

• 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 downstream 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 and author 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.
• Author validation protocols, reports, and technical documentation.

Continuous Improvement

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

 

Competencies

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

 

What you’ll bring to the role: 

Essential Requirements: 

• Master’s degree (M.Sc./M.Tech) in Biotechnology, Bioprocess Engineering, Biochemical Engineering, Chemical Engineering, or a related field is preferred with min 5+ yrs exp.
• PhD in Biotechnology, Bioprocess Engineering, Chemical Engineering, or a related discipline is considered an advantage.
• Proven knowledge of downstream biologics manufacturing processes, including chromatography, filtration, UF/DF, SPTFF, process validation, and technology transfer.
• Experience working in a GMP-regulated biopharmaceutical environment with exposure to process lifecycle management, manufacturing support, investigations, CAPA, and continuous improvement initiatives.

 

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

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)