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Expert Science & Technology (Stability Management)

Employer
Novartis
Location
Durham, North Carolina
Salary
Competitive
Closing date
Feb 2, 2023

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Sector
Science, Pharmaceutical
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
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Job Description

12,000. The number of associates worldwide working together to reimagine medicine!

The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.

The Expert Science & Technology role will manage the planning/strategy, study designs, data and analysis, report generation and regulatory submissions for development stability programs within the Technical Research & Development, Cell & Gene Therapy Organization.

Your responsibilities will include, but are not limited to:

• Responsible for establishing stability strategies and designing protocols.
• Own and generate technical reports, records, and regulatory submission source documents.
• Data management to support the Stability Programs including the administration of stability samples, associated document coordination, and collection and evaluation of data.
• Management of external service providers performing execution and testing of stability studies.
• Ensures scheduling of stability lots, tracks stability time points and evaluates stability data on a routine basis.
• Document owner for procedures and work instructions in support of stability processes.
• Owner, assessor and/or reviewer of stability related out of trend (OOT), out of specification (OOS) events, deviations and change controls.
• Support of Sample Management duties and other related job duties as assigned.

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:
• Bachelors' Degree in scientific discipline with a general understanding of biopharmaceutical or Gene therapy processes. A combination of education and applicable experience may be considered in lieu of a scientific degree.
• 3+ years of GMP stability experience, including managing programs, designing studies, performing data analysis and trending, authoring of reports and regulatory submission documents.
• Thorough knowledge of ICH guidelines, specifically stability guidelines.
• Experience in LIMS systems (Labware LIMS beneficial), and statistical tools such as JMP and Minitab.
• Excellent oral and written communication skills with technical writing experience.
• Expertise in use of MS suite of programs (outlook, excel, powerpoint, word, etc).
• Ability to work independently, collaboratively, and effectively. Problem-solving aptitude with ability to prioritize and deliver on tight timelines.
• Experienced quality professional with knowledge of the drug development and quality control process and associated methods.

Desirable requirements:
• Experience with LIMS implementation (Labware LIMS beneficial)

The pay range for this position at commencement of employment is expected to be between $84,000 and $126,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, 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!

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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.
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