Technical Manager ESO Bio DP/FP

sandoz; Turakapally; On-site; INR 3,500,000 - 7,500,000; Full time

Job summary

Sandoz seeks a Technical Manager / Senior Technical Manager MS&T for Drug Product, Finished Product to provide expert input on manufacturing, validation and product transfers. You will lead technical transfers, support lifecycle management, and ensure robust processes with external suppliers and internal teams.

The role requires solid experience in aseptic operations, GMP practices, project leadership and strong problem solving across global environments to deliver products that meet quality

Qualifications

• University degree required in Pharmacy, Biotechnology, Chemistry or equivalent.
• Minimum 8 years in pharmaceutical manufacturing (aseptic operations).
• Strong project management and problem-solving skills in a global/matrix environment.

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 and supports SGD that new products and processes are well developed for commercial scale and lifecycle.
• Contribute to the registration strategy and ensure alignment of regulatory requirements.

Skills

Project management

Problem solving

GMP knowledge

Technology Transfer

Sterile manufacturing

Process validation

Global/matrix experience

Education

Bachelor's/Master in Pharmacy/Biotechnology/Chemistry or equivalent

Master's degree desirable

Job description

Job Description Summary

The Technical Manager / Senior Technical Manager MS&T for Drug Product, Finished Product 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

The Technical Manager / Senior Technical Manager MS&T for Drug Product, Finished Product 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 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 (aseptic operations), solid understanding of biotechnology and field of expertise (aseptic operations and device knowledge, ...).
• Demonstrated accomplishments in a global/matrix environment.
• Strong project management experience and problem solving skills.
• Strong Technical expertise in (sterile) manufacturing process science and drug development.
• Experience with Tech Transfers 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, 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