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Technical Development Director, Analytical Development

Princeton, New Jersey, United States
Closing date
Dec 13, 2022
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Job Description

$500 million! That’s the savings Sandoz has provided in just two years to the US healthcare system as a result of the successful adoption of one of our oncology supportive care biosimilar into clinical practice. Sandoz has eight biosimilar approved globally - including four in the US - and more than ten in the pipe-line. Biosimilar may enable more patients to access advanced biologic medicines earlier, and Sandoz has proven that biosimilar offer significant savings for overburdened health systems. We are looking for curious, innovative, driven people to help us get these products into the market. Maybe that’s you.

Your responsibilities will include, but are not limited to:
• Influence product strategy and executes, product development activities related to analytical development/ transfer with external BD partners (incl. CMOs, CDMOs) and lead alignment with CMC sub-team.
• Owns the delivery of product development initiatives/projects with emphasis on analytics for the development of NDAs, 505(b)(2)s, generic ANDAs (505j) products through various milestones of product development.
• Be the partner of reference to lead opportunities related to pre-due diligences, due-diligence (DD) for in-licensing, co-development, CDMO or acquisition of products and related assets (dossiers, analytical technology, etc.). This includes a thorough review and understanding of the offered products’ characteristics and performance based on quality attributes, robustness of formulation and overall analytics.
• Apply high quality standards/ principles during the different stages of product development, including review of drug product & API characterization, raw material quality attributes, drug-device compatibility, design of experiments, stability testing, analytical methods development & validation/optimization, and statistical evaluation of data.
• Leading engagements with the regulatory agencies, including Complex Gx product development and pre-submission meetings for related projects in scope.
• Evaluate the characterization and comparability plans and reports for complex dosage forms and propose technique as needed. Responsibility/accountability for characterization/comparability plan/protocols/reports for the in-licensing, co-development asset.
• As part of project responsibility also prepare DD reports and summarize and communicate the findings concisely.
• Proactive management of project risks, opportunities and establishing comprehensive mitigation plans when it comes to product development/analytical challenges. Establish project plan baselines and document assumptions. Compile and challenge project schedules with the project team, manage timelines through critical path analysis, monitor completion of key development tasks through milestone completion, quality gates, and stage gating processes. Manages project Budgets, Contract Milestones and Spend and provide updates on a monthly basis to the Product Development Senior Leadership. Performs data-entry function on project timelines, project status report and management dashboard.

This position will be located at the Princeton site and will not have the ability to be located remotely. This position will require 25% travel as defined by the business (domestic and/ or international).

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:
Education: Master level degree required, PhD preferred
• Minimum 10 years’ experience in pharmaceutical development environment with a broad exposure to other R&D functions: Quality, Regulatory, Commercial, and Business development.
• Broad knowledge of current & future analytical technologies/techniques, with strong knowledge in physico-chemical characterization of materials, analytical method development/validation, stability, method transfer, and troubleshooting of analytical methods for Simple & Complex Generics dosage forms (including injectables).
• Extended knowledge of analytical techniques for development of different dosage forms including but not limited to HPLC, UPLC, GC, IR, UV, NMR, Raman, Mass spectroscopy etc.
• Strong experience working/coordinating BD & DD partners for Complex Generics (505j, 505b2 regulatory pathway) is required as well as interaction with FDA.
• Extensive experience in analytics of de-formulation of branded product, comparability study.
• Drug-device combination product experience is desired;
• Broad(er) scientific as well as strategic background is desired.
• Strong Drug substance (API) synthesis and characterization knowledge.

Why Sandoz?
We’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? 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 Sandoz!

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

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.

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected] .
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