Novartis Hiring for x Process Expert (Sun-Wed, AM Shift) job in Morris Plains Full Time

About the role
Location: Morris Plains, NJ. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.

As a Process Expert you will provide front line support for all issues related to the manufacturing process while continuously improving in quality and efficiency, and in compliance to cGMPs, SOPs and applicable guidelines and requirements.

Key Responsibilities:
• Provide front line technical and procedural support to manufacturing, working with the cell processing team, focusing on manufacturing each batch safely, on time, in compliance with the batch record and quality requirements.
• Author and conduct manufacturing investigations for product and non-product deviations. Conduct manufacturing investigations for Out Of Expectation (OOE), Out Of Specification (OOS), Out of Tolerance (OOT) results. Use process knowledge and root cause investigation tools to analyze data and to identify root causes of product and process failures.
• Support the process of escalation of deviations when appropriate according to escalation guidelines.
• Initiate CAPAs and CAPA effectiveness checks to eliminate/mitigate deviations.
• Identifies opportunities for process, operational, and quality improvements in conjunction with Manufacturing Team (PU) and Operational Excellence Team (OpEx).
• Evaluates manufacturing pre-production technical planning, review of technical data of incoming apheresis materials, to ensure timely and required batch pathway processing by the manufacturing team.
• Provide timely support for process technology transfer activities from clients/3rd parties.
• Owns the Training Curriculum for this Job Profile and provides the necessary training and support to new associates joining the Process Expert position. Coach new investigators as part of the Investigator Certification Program.
• Maintain their processes at inspection readiness level and to provide the necessary support in any internal or external audit.

Additional Notes: This role is a Sunday-Wednesday AM shift position. The role is for 4 days a week for 10 hours per day.

Commitment to Diversity & Inclusion:
We 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.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

• Novartis: e-mail [email protected] or call +1 (877)395-2339
• Sandoz: e-mail [email protected] or call: +1-609-422-4098

Role Requirements
• Education: Bachelor degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy, or equivalent scientific degree. Desirable MSc. or equivalent experience
• Minimum 3 years’ experience in GMP manufacturing role on the shop floor and/or QA/QC.
• Proven process understanding (Pharma, GMP, Regulatory aspects).
• 1 year of deviation/root cause analysis experience

Desirable Requirements:
• Cell & gene therapy experience is preferred.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: People and Culture | Novartis.

Pay transparency statement: The pay range for this position at commencement of employment is expected to be between $84,000 and $126,000 a year; however, while salary ranges are effective from 1/1/24 through 12/31/24 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. 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.

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: Novartis Talent Pool.