343015BR
Apr 05, 2022
USA

Job Description

50! The number of parenteral, topical, ophthalmic and inhaled projects of our compelling and rich development pipeline. We are searching for a Senior Expert / Analytical Project Leader to support Analytical Research & Development (ARD).

ARD sits within the Global Technical R&D department of Global Drug Development and plays an essential role in the characterization and analysis of Small Molecule Drug Substances and Drug Products from the time they leave the discovery laboratory until they are transferred to Commercial Production.

We are looking for a highly motivated, experienced Senior Expert / Analytical Project Leader with a strong background and experience in Ophtha/Parenteral and early phase development to join our team. Expertise in Ophtha analytics and regulatory submissions are major assets.

Responsibilities will include but are not limited to:

• Leading and managing analytical activities within a global project team (e.g. control strategy, specification setting strategy, method development, validation, stability, and release testing).
• Writing analytical source documents (e.g., analytical methods, specifications, validation reports, stability reports)
• Providing valuable input to the analytical CMC documents and supporting regulatory submissions
• Preparing analytical project plans and being accountable to meet quality, timelines, and budget for assigned projects.
• Managing interactions and contributing to a high level of collaboration with internal and external stakeholders
• Leading outsourced analytical activities at CROs / CDMOs and contribute to manage the external partnership.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What you’ll bring to the role:
• PhD in analytical chemistry or equivalent and a minimum of 5 years’ experience in the pharmaceutical industry in analytical development, preferable in early phase development of sterile Ophtha/Parenteral products.
• Proven knowledge in early phase Ophtha/Parenteral development and filings.
• Proven leadership experience in managing development projects, ideally in a global matrix environment.
• Excellent understanding and awareness of regulatory guidelines for analytical development.
• Collaborative spirit, self-driven attitude, high level of learning agility are key attitudes.
• Strong quality focus and experience in a cGMP environment.
• High level of motivation, excellent collaborative spirit and agility are key elements to our success.

Why consider Novartis?

799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
*Some restrictions on flexible working options may apply and will be discussed during interview if applicable.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network

Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

https://www.novartis.com/careers/careers-research/notice-all-applicants…
Global Drug Development
TECHNICAL R & D GDD
USA
Fort Worth, TX
Research & Development
Full Time
Regular
No
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343015BR

Senior Expert / Analytical Project Leader

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