May 18, 2022

Job Description

Associate Director in Drug Substance Biologics and CGT Development Lead (f/m/d), Schaftenau, Austria

Over 40! This is the number of years of expertise in biotech production and cutting-edge process development together with an outstandingly growing product portfolio that is waiting for an experienced individual to manage various process development activities as a global Drug Substance Lead.

Role purpose

As an Associate Director in Biologics and Cell and Gene Therapy Drug Substance Development Lead (f/m/d) you will be part of a world class, cross-functional R&D organization for development of biological DS manufacturing processes, covering the full spectrum of Novartis biologics and cell and gene therapy pipeline. You will have global exposure on various development activities in various stages of process development (e.g., optimization, process characterization, tech transfers, process validation), you will be a constant member of CMC teams and a key contributor to ensure scientific support as well as project management of DS process development. In this position you will further improve your project management and leadership skills and will interact with early and late-stage development units of Novartis Biologics to test innovative treatments in clinical trials and bringing them on the market!

Your key responsibilities:
Your responsibilities include, but are not limited to:
• Provide scientific and project management leadership for various early, and/or late-phase biologics drug substance process development activities, from early development to commercialization for programs including monoclonal antibodies, new and biosimilar entities, nucleic acids, fragments, antibody conjugates, bi-, or trispecific antibodies.
• Collaborate closely with key stakeholders, interfaces within the organization and maintain efficient communication towards them, actively contribute to resource and budget planning and monitoring.
• Lead assigned DS development team(s) in a matrix organization, provide scientific and project managerial support to deliver DS processes for clinical trials and support CTA submission.
• Write/lead/review defined development related documentation, e.g. characterization studies, transfer protocols, reports; control strategy documents.
• Act as recognized expert in the Novartis networks and international scientific community with excellent leadership skills.
• Contribute to responses for health authorities, support audits and inspections.
• Set priorities for the team; coach DS team members and helping them to grow and motivate them as appropriate by an encouraging and servant leadership.
• Proactively communicate overall project strategy and resource demand. Adapt project strategy and prioritize project activities, according to agreed timelines.
• Contribute to continuous improvement of scientific knowledge and approaches.
• Ensure, strengthen the application of harmonized standards, relevant SOPs.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• PhD in biotechnology, biochemical engineering, biology, chemistry, biochemistry or similar
• >6 years of industry experience in biopharmaceutical industry, being a recognized expert in the scientific community.
• Excellent understanding of either or both USP and DSP process development for proteins and nucleic acids.
• Excellent theoretical and scientific knowledge in the relevant area of expertise.
• Excellent communication skills in English, written and verbal. German knowledge is a plus.
• Scientific project management and leadership skills as well as presentation skills.
• Good understanding of regulatory expectations.
• Good understanding of GMP.

Desirable requirements:
• Excellent organizational skills, team player, agile and dedicated personality.
• Excellent problem-solving mind-set for complex tasks and topics of strategic relevance, attitude to resolve challenges, interdisciplinary thinking.
• Ability of properly balancing between efforts, risks and benefits.
• Demonstrated strategic agility and a comprehensive picture on interactions of different functions with a deep understanding of the business.
• Demonstrated skills working in cross-functional/ international environment.
• Ability to coordinate a number of tasks simultaneously, prioritize and deliver against tight timelines.
• Ability to lead/facilitate meetings composed of cross-functional experts.
• Excellent problem-solving mind-set, attitude to resolve challenges, interdisciplinary thinking.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 63.388,92 /year (on a full time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications, and individual competencies.

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
Research & Development
Full Time
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Associate Director Science & Technology (f/m/d)

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