Job Description Summary

This position will be located at Morris Plains, NJ and will not have the ability to be located remotely.

This role is responsible for the team of SMEs for manufacturing aseptic behaviors related to technical training and shopfloor behaviors. This role provides guidance and structure to support investigation and leading continuous improvement to aseptic processing and training within the manufacturing area.
#LI-Onsite

Key Responsibilities:
Leadership:
* Acts in accordance with Novartis Values & Behaviors and supports a team culture that is inspired, curious and unbossed
* Provides visible leadership to all team members by providing coaching and support
* Empowers team members to react appropriately to unplanned situations, driving decision making to the appropriate levels
* Support teamwork, strong communication and motivation within and across teams

Process & Improvements:
* Act as SME on manufacturing aseptic behaviors, aseptic training, cross-contamination control strategies and technical approaches.
* Participate in cross functional aseptic governance and provide insight to aseptic behaviors within manufacturing
* Provide timely updates to management on status of all GMP-related projects
* Work with regulatory department to ensure process related improvements are handled appropriately within regulatory framework and timelines
* Oversee and coordinate change controls for process and product-related changes

Shop Floor Support:
* Provide front line technical and procedural support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements
* Leads decision making effort for aseptic process interventions

Job Description

Desirable Requirements:

• BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree. Desirable MSc. or equivalent experience
• Minimum five years' experience in aseptic GMP manufacturing environment on the shop floor.
• Proven understanding of aseptic techniques, sterility assurance and cell manufacturing (Pharma, GMP, Regulatory aspects).
• Project Management, People Management or Leadership experience, and Training experience highly desirable.
• Direct management experience highly desirable

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $108,500 and $201,500/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, 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.

Company will not sponsor visas for this position.

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

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 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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com 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 Range

$108,500.00 - $201,500.00

Skills Desired

Assembly Language, Change Control, Chemical Engineering, Chemistry, Continual Improvement Process, Efficiency, General Hse Knowledge , Good Documentation Practice, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Process Control, Productivity, Risk Management, Root Cause Analysis (RCA), Scheduler, Six Sigma, Sop (Standard Operating Procedure), Team Work, Technology Transfer, Web Methods FlowPDN-9e4b230e-a509-4517-add7-d098c33385d3