Technical Manager ESO Bio DP/FP

IN04 (FCRS = IN004) Sandoz Private Limited; Elsene; In loco; EUR 110.000 - 150.000; Tempo pieno

Descrizione del lavoro

Sandoz is seeking a Technical Manager / Senior Technical Manager MS&T for Drug Product to provide expert leadership in manufacturing and packaging process design, validation, and tech transfers. You will act as the Technical Transfer Lead for legacy and new products and support supplier relationships with robust technical and scientific process guidance.

Responsibilities include overseeing validation at external suppliers, ensuring successful transfers, and contributing to regulatory strategies

Competenze

• University degree required; Master desirable.
• Min. 8 years in pharmaceutical manufacturing (aseptic).
• Global/matrix experience preferred.
• Strong PM and problem-solving skills.
• Tech Transfer experience a plus.

Mansioni

• Represent interface to external supplier for robust process capability.
• Participate in supplier- and product evaluation and selection.
• Oversee validation at external supplier.
• Ensure transfers and launches with external involvement.
• Lead/Support Product/Technical Stewardship for key molecules.
• Assess impact of technical changes and design scope of batches.
• Lead root-cause investigations for product/process issues.
• Interface with SGD to ensure development for commercial scale.
• Contribute to registration strategy and regulatory alignment.

Conoscenze

Applied Statistics

Change Control

Chemical Engineering

Lean Manufacturing

Process Control

Process Simulation

Risk Management

Root Cause Analysis

Six Sigma

Statistical Analysis

Technology Transfer

Formazione

University Degree in Pharmacy, Biotechnology, Chemistry or equivalent

Strumenti

GxP Knowledge

Descrizione del lavoro

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

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!