Technical Expert MS&T Bio Similar/ Large Molecules DS/DP
Sandoz · Telangana (Sandoz)
Job Description Summary
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!To serve as the primary technical interface between Sandoz Bio Manufacturing sites and the Global MS&T Capability Hub for Large Molecule Drug Substance & Drug Products operations. The Technical Expert provides specialized guidance on upstream and downstream process design, scale-up strategies, cleaning and process validation, and resolution of complex technical challenges. This role ensures robust process performance, product quality, and regulatory compliance across the product lifecycle, while enabling efficient technology transfers and driving continuous improvement.
The Technical Expert also supports ESO Technical Managers in conducting technical due diligence during the pre-evaluation phase, in collaboration with BD&L, to identify suitable external suppliers. The role contributes to the preparation and review of documentation associated with this process.
Additionally, the Technical Expert facilitates product transfers for both legacy and new biologic products—from Sandoz Development to internal manufacturing sites, external suppliers, or between suppliers. They align with Development teams during early-stage process design and support associated documentation. The role provides technical and scientific support to Supply Relationship Teams (SRTs), working closely with QA Managers, Site Change Coordinators, and Supply Relationship Managers to evaluate compliance activities such as deviations, change controls, complaints, and CAPAs. It ensures smooth knowledge and information flow across functions, with a focus on biologics process and product expertise.
Job Description
Your Key Responsibilities:
Your responsibilities include, but not limited to:
Key Responsibilities:
- Technical Support to Internal Sites and CMOs Act as Technical Expert for assigned internal manufacturing sites or CMOs, ensuring process capability and maintaining products in a validated state.
- Apply science- and risk-based approaches to ensure sustainable product quality.
- Ensure availability of all relevant technical documentation (protocols, reports, risk assessments, concept papers, scientific justifications) ahead of planned site activities.
Product & Technical Stewardship
- Maintain oversight and deep understanding of the entire manufacturing process across the product lifecycle.
- Identify and monitor CQAs, CMAs, and CPPs to ensure process robustness and product quality.
- Analyze manufacturing data (OPV, CPV, APQR) to assess state of control and recommend improvements.
- Evaluate technical changes, assess feasibility, and define scope/design of technical batches.
- Contribute to registration strategy and align regulatory timelines for changes, transfers, launches, and deviations.
- Lead/support root cause investigations for product/process failures and drive remediation/improvement initiatives.
- Collaborate cross-functionally with Quality, Operations, Engineering, and Development teams.
- Share best practices and lessons learned across divisions and sites.
Validation Support
- Define and implement validation strategies and supporting documentation.
- Maintain validation oversight and ensure products remain in a validated state.
- Review QRAs and challenge control strategies based on CQAs, CPPs, and CMAs.
- Ensure technical batches generate sufficient process knowledge.
- Support creation and review of validation protocols and reports.
- Contribute to revalidation planning and documentation.
Launch & Transfer Support
- Participate in supplier/product evaluation and selection processes.
- Gather and document technical information on manufacturing capabilities of sites/CMOs.
- Provide data and documentation for tech transfer activities, leveraging existing process knowledge.
- Define product acceptance criteria and monitor performance post-transfer.
- Ensure successful, well-documented product transfers and launches.
- Actively support governance processes for product launch and transfer.
Interface with Development
- Ensure new products and processes are designed for commercial scalability and lifecycle sustainability.
- Provide input at formal stage gates during development and up to first OPV/APQR.
- Support development of control strategies that meet regulatory and operational requirements.
Manufacturing & Operational Excellence
- Lead design and control optimization projects to improve process robustness and sustainability.
- Provide SME-level expertise for process characterization of biologics manufacturing.
- Prepare high-quality design and operational documents.
- Proactively take on challenging projects driven by evolving regulatory requirements, audits, and compliance needs.
Training
- Own and maintain the training curriculum relevant to the job description and responsibilities.
What you'll bring to the role:
Minimum Requirements:
Ideal Background
Education (minimum/desirable):
- Experience in biologics manufacturing including cell culture, fermentation, purification, and formulation processes
- Post Graduate in Pharmacy/Biology/Bio tech/Relevant Life Sciences/ Ph.D. in Pharmaceutical Technology (preferred)
Languages
- Fluent in English & Languages in the Region
Relevant Experiences
- 8-12 years of relevant experience in manufacturing. Additional specialist experience is preferred
- Strong knowledge of regulatory guidelines: USFDA, EMA, ICH, ASTM, SUPAC.
- Expertise in QbD, DoE, Minitab, and statistical analysis.
- Ability to prepare high-quality design and operational documents for equipment qualification, verification, and continuous process validation.
- Excellent communication and cross-functional collaboration skills.
- Ability to manage multiple complex projects in a global matrix environment.
You'll receive:
Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit 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, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
#Sandoz
Skills Desired
Applied Statistics, Assembly Language, Change Control, Chemical Engineering, 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, Manufacturing Technologies, Process and Cleaning Validation, Process Control, Process Simulation, Risk Management, Root Cause Analysis (RCA), Scientific Method, Six Sigma, Statistical Analysis, Technology Transfer