Technical Manager ESO Bio DP/FP

Biopharma Careers

Telangana

On-site

INR 3,000,000 - 6,000,000

Full time

14 days+

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Job summary

Sandoz seeks a Technical Manager / Senior Technical Manager MS&T for Drug Product, Finished Product to provide expert design and validation guidance. This role leads technology transfer for legacy and new products, evaluates projects, and supports supplier teams to ensure robust manufacturing and lifecycle readiness.

Ideal candidates will have a pharma background in aseptic operations, hands-on validation, and proven capability in global/regulatory collaboration.

Qualifications

University degree in Pharmacy, Biotechnology, Chemistry or equivalent (Master prefered).
Minimum 8 years in pharmaceutical manufacturing (aseptic operations).
Strong project management and problem solving skills.
Experience with Tech Transfers is a plus.

Responsibilities

Represent the technical interface to external suppliers to ensure robust product process capability.
Participate in supplier- and product evaluation and selection processes.
Oversee validation oversight at external suppliers.
Ensure successful transfers and launches of products with external manufacturing involvement.
Lead Product/Technical Stewardship for defined key molecules.
Assess impact of technical changes, feasibility and design of technical batches.
Lead root cause investigations of product and process failures.
Interface with Sandoz Global Development to ensure well-developed processes for commercial scale and life cycle.
Contribute to registration strategy and ensure regulatory alignment.

Skills

Sterile manufacturing

Technology Transfer

GMP knowledge

GDP knowledge

Process & Cleaning Validation

Process Control

Process Simulation

Risk Management

Root Cause Analysis

Scientific Method

Six Sigma

Statistical Analysis

Technology Transfer

Applied Statistics

Assembly Language

Change Control

Chemical Engineering

Continual Improvement Process

Cost Reduction

Data Analytics

Electronic Components

Lean Manufacturing

Manufacturing Process

Manufacturing Production

Manufacturing Technologies

Quality Systems

Education

University degree in Pharmacy / Biotechnology / Chemistry or equivalent (Master 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

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