Technical Manager ESO Bio DP/FP

Sandoz; Telangana; Sur place; INR 3 500 000 - 5 500 000; Plein temps

Résumé du poste

Sandoz is seeking a Technical Manager / Senior Technical Manager MS&T for Drug Product, Finished Product. You will provide manufacturing/process design expertise, validation, and technical transfer leadership across legacy and new products.

Key responsibilities include external supplier collaboration, product evaluations, validation oversight, and ensuring smooth transfers and launches for commercial scale products.

Qualifications

• University degree as specified; Master’s degree desirable.
• Min. 8 years in pharmaceutical manufacturing (aseptic operations).
• Experience in global/matrix environments and project management.
• Technical expertise in sterile manufacturing and drug development.

Responsabilités

• Represent the technical interface to external suppliers 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 transfers and launches with external manufacturing involvement.
• Lead or support root cause investigations of product and process failures.
• Support SDS interface to ensure new products/processes are well developed for commercial scale.

Connaissances

Project management

Sterile manufacturing

Tech transfers

Problem solving

Global/matrix environment

Process validation

Formation

Master's degree in Pharmaceutical Sciences / Biotechnology / Chemistry

Bachelor's degree in Pharmacy / Biotechnology / Chemistry

Outils

GMP knowledge

Description du poste

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 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 withexternal manufacturing involvement.
• Perform Product/Technical Stewardship for defined key molecules.
• Assess impact of technical changes, technicalfeasibilityand scope / design oftechnical batches.
• Lead or support root cause investigation of product and process failures.
• Represent the interface toSandozinternalGlobalDevelopment(SGD)andsupportsSGDthat newproducts and processes are well developed for commercial scale and entireproduct 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,Chemistryor equivalent(Master is desirable).
• Min.8years in pharmaceutical manufacturing(aseptic operations), solidunderstanding of biotechnologyand field ofexpertise(aseptic operationsand deviceknowledge, …).
• Demonstratedaccomplishments in a global/matrix environment.
• Strong project management experience andproblem solvingskills.
• StrongTechnicalexpertisein(sterile)manufacturing process science and drugdevelopment.
• 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