Expert Drug Supply (Compliance Investigator)

Job Description

1 purpose! Novartis expands its early development and innovative CAR-T cell therapy manufacturing capabilities in its newly launched Center of Excellence, located in the East Hanover, NJ campus. Our therapies are being developed as transformative treatments with life-saving potential for various B cell malignancies and other oncological diseases. We look to be bold with purpose, as we reimagine medicine and lead the way in advancing scientific breakthroughs for patients.

The Expert Drug Supply will author and oversee deviations, investigations, CAPAs, and related reports to closure within established timelines for the manufacturing department. Own and drive change controls from initiation to closure.

Your responsibilities will include, but are not limited to:

Deviation and Investigation Management:
• Open deviations within required timeframes
• Author investigations and support resolution of product complaints, Out Of Expectation, Out Of Specification, Out of Tolerance results
• Use process knowledge and root cause investigation tools to identify root causes of product and process deviations.
• Supports documentation of experimental plan, execution, and results to support investigations
• Ensures robustness (complete, accurate and defendable) of all critical and major investigations
• Work cross-functionally to assess and analyze deviations and investigations to determine im-pact

Corrective and Preventative Actions:
• Generation and documentation of effective corrective and preventative actions
• Ensures all CAPAs are implemented through GMP systems (e.g. MBR revision, training, etc.)
• Monitor and ensure effectiveness checks of CAPAs are conducted

Communication and Process Improvements:
• Provide timely updates to management on status of all GMP-related investigations
• Identifies opportunities for operational improvements for both manufacturing and deviation/investigation management

Quality Events:
• Owns and manages Quality Events related to GMP manufacturing

Change Controls:
• Owns and manages Quality Events related to GMP manufacturing

Training:
• Owns the Training Curriculum for this Job Profile and provides the necessary training and support to new associates joining this position.

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:
• BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
• Desirable MSc. or equivalent experience.
• 3 years of experience in GMP manufacturing role on the shop floor and/or QA/QC
• Proven process understanding (Pharma, cGMP, Regulatory aspects)

The pay range for this position at commencement of employment is expected to be between $80,000 and $120,000 /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.