Senior Technical Manager MS&T DS

Sandoz

India

On-site

INR 3,500,000 - 5,500,000

Full time

11 days ago

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Job summary

Sandoz in India seeks a Senior Technical Manager MS&T for Drug Substance to lead manufacturing process design, validation, and tech transfer across global development teams. You will drive product transfers, due diligence, and technical stewardship to ensure robust, compliant processes for commercial scale.

Key responsibilities include overseeing external supplier transfers, product evaluations, validation oversight, and collaboration with SGD to align development with regulatory strategies.

Qualifications

  • Must have a university degree in Pharmacy, Biotechnology, Chemistry or equivalent (Master preferred).
  • Min. 8 years in pharmaceutical manufacturing with biotech understanding.
  • Global/matrix environment experience and strong project management.
  • Technical expertise in manufacturing process science and drug development.

Responsibilities

  • Represent technical interface to external suppliers to ensure robust product/ process capability.
  • Participate in supplier- and product evaluation and selection.
  • Oversee validation at external suppliers and ensure documented transfers.
  • Lead root cause investigations of product/ process failures.
  • Support transfers and launches with external manufacturing involvement.
  • Collaborate with SGD to ensure development aligns with commercial scale and lifecycle.

Skills

Applied Statistics
Assembly Language
Back-End Development
Biotechnology
Chemical Engineering
Chemistry
Design Development
Electronic Components
General Hse Knowledge
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

Education

University Degree in Pharmacy, Biotechnology, Chemistry or equivalent

Job description

Job Description Summary

Senior Technical Manager MS&T for Drug Substance provides technical expertise on manufacturing and packaging process design, process- and cleaning validation and resolution of technical issues. Acts as responsible Technical Transfer Lead to facilitate Product Transfers for legacy and new development products, performs due diligence evaluations for new projects and act as MS&T representative in an assigned Supplier Relationship Team (SRT) to provide technical & scientific process support to respective Supplier Relationship Teams (SRT).

Job Description

Senior Technical Manager MS&T for Drug Substance provides technical expertise on manufacturing and packaging process design, process- and cleaning validation and resolution of technical issues. Acts as responsible Technical Transfer Lead to facilitate Product Transfers for legacy and new development products, performs due diligence evaluations for new projects and act as MS&T representative in an assigned Supplier Relationship Team (SRT) to provide technical & scientific process support to respective Supplier Relationship Teams (SRT).

Your Key Responsibilities

Your responsibilities include, but not limited to:

  • Represent the technical interface to external supplier to ensure robust productprocess capability.
  • Participate in supplier- and product evaluation and selection process.
  • Responsible for validation oversight at the external supplier.
  • Ensure successful and well-documented transfers and launches of products with external manufacturing involvement.
  • Perform Product/Technical Stewardship for defined key molecules.
  • Assess impact of technical changes, technical feasibility and scope / design of technical batches.
  • Lead or support root cause investigation of product and process failures.
  • Represent the interface to Sandoz internal Global Development (SGD) and supports SGD that new products and processes are well developed for commercial scale and entire product life cycle.
  • Contribute to the registration strategy and ensure alignment of (regulatory).
Essential Requirements
  • University Degree in Pharmacy, Biotechnology, Chemistry or equivalent (Master is desirable).
  • Min.8years in pharmaceutical manufacturing, solid understanding of biotechnology and field of expertise.
  • Demonstrated accomplishments in a global/matrix environment.
  • Strong project management experience and problem-solving skills.
  • Strong Technical expertise in manufacturing process science and drug development.
  • Experience with Tech Transfers is a plus.
  • Fluency in English, Slovenian language is a plus.
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!

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

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