What are the responsibilities and job description for the Process Expert, PM Shift position at Novartis?
Summary
Location: This role is based in Millburn, NJ. Novartis is unable to offer relocation support: Please only apply if the location is accessible for you.
Step into a role where your expertise supports the cutting edge of Radioligand Therapy manufacturing. As a Process Expert, you’ll be the go-to partner on the shop floor—ensuring each batch is produced safely, efficiently, and in full compliance. You’ll lead investigations, drive continuous improvement, and support seamless technology transfers, all while mentoring others and maintaining inspection readiness. This is your opportunity to make a meaningful impact in a dynamic, purpose-driven environment where innovation and quality go hand in hand.
About the Role
Key Responsibilities:
- Provide real-time technical and procedural support to production technicians on the manufacturing floor
- Lead investigations for deviations, including Out Of Specification and Out Of Expectation results
- Collaborate cross-functionally to assess deviation impact and identify root causes
- Initiate and track CAPAs, ensuring timely resolution and effectiveness verification
- Identify and implement process and quality improvements with Manufacturing and Operational Excellence teams
- Analyze manufacturing data to detect process trends and escalate potential issues
- Escalate deviations according to guidelines and present details clearly, including root cause and CAPAs.
- Deliver targeted training and coaching to new team members and investigators
- Maintain inspection readiness and support internal and external audits
Essential Requirements:
- Bachelor's degree in any scientific discipline, such as Biology, Chemistry, Physics, Environmental Science, or equivalent professional experience in lieu of a degree.
- Minimum 3 year’s of previous GMP experience is required, including pharmaceutical manufacturing experience.
- Demonstrated experience leading investigations and driving root cause analysis. Strong understanding of deviation management, CAPA processes, and regulatory compliance
- Excellent communication and collaboration skills across cross-functional teams
- Technical writing skills
Desirable Requirements:
- Experience working in a radiopharmaceutical or radioligand therapy manufacturing environment
- Knowledge of Lean Six Sigma or other continuous improvement methodologies
Shift: Wed-Sat, PM Shift (1pm-11:30pm). Flexibility to work alternate shifts and overtime to support the business, as needed.
Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $77,000 to $143,000 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Company will not sponsor visas for this position.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & 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 to perform the essential functions of a position, please send an e-mail to [email protected] or 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.
Salary : $77,000 - $143,000