Senior Technical Manager MS&T DS

IN04 (FCRS = IN004) Sandoz Private Limited; Turakapally; On-site; INR 4,000,000 - 6,000,000; Full time

Job summary

Sandoz is seeking a Senior Technical Manager MS&T for Drug Substance to provide technical leadership on manufacturing, packaging process design, validation, and product transfers. You will lead technical due diligence for new projects and serve as the MS&T representative in supplier teams to support process development and regulatory alignment.

The role requires a university degree in a related field, 8+ years in pharma manufacturing, and strong project management with English fluency.

Qualifications

• 8+ years in pharmaceutical manufacturing.
• Strong project management and problem-solving skills.
• Experience with Tech Transfers is a plus; fluency in English; Slovenian a plus.

Responsibilities

• Represent the technical interface to external supplier to ensure robust product process 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).

Skills

Manufacturing Process

Tech Transfers

Project Management

Problem Solving

Biotechnology

Chemistry

Quality Systems

GMP Knowledge

RCA

Leadership

Education

Bachelor's degree in Pharmacy/Biotechnology/Chemistry

Master's degree desirable

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).

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:

• Represent the technical interface to external supplier to ensure robust product process 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).

What you’ll bring to the role:

Essential Requirements:

• University Degree in Pharmacy, Biotechnology, Chemistry or equivalent (Master is desirable).
• Min. 8 years 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! 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}

Our Purpose

Our Purpose here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!