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

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

About this role:
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.

The Process Expert will provide front line support for all issues related to the manufacturing process, continuously improving in quality and efficiency, and in compliance to cGMPs, SOPs and applicable guidelines and normatives.
Key Responsibilities:
Shop Floor Support:
• 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.
• Provides latest information regarding best practices, investigation findings, CAPAs, MST/TRD experiences to manufacturing SMEs.
• Perform data analysis and identifies potential process shifts/trends and escalate as necessary.
Deviations, Investigations, and CAPAs:
• Author investigations for product and non-product deviations.
• Conduct manufacturing investigations for Out Of Expectation (OOE), Out Of Specification (OOS), Out of Tolerance (OOT) results.
• Work cross-functionally to assess deviation impact and identify root causes.
• Work with Scheduling and QA to ensure that batches of are released on time through the closure of robust investigations and impact/risk assessments.
• Use process knowledge and root cause investigation tools to analyze data and to identify and root causes of product and process failures.
• Initiate CAPAs and CAPA effectiveness checks to eliminate/mitigate deviations.
• Support the process of escalation of deviations when appropriate according to escalation guidelines. Present escalation events and provide deviations details clearly and on-time (root cause and CAPAs).

Business Process & Improvements:
• Identifies opportunities for process, operational, and quality improvements in conjunction with Manufacturing Team (PU) and Operational Excellence Team (OpEx).
• Execute process technical batches to generate sufficient process knowledge by thoroughly testing critical variables.
• 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 updates to management on status of manufacturing performance. Escalate potential performance issues to 3rd parties.
Technology Transfer:
• Provide timely support for process technology transfer activities from clients/3rd parties.
Training:
• Develop and provide training (as immediate response to unexpected events, for technical document execution, and new products/processes) to the Cell Processing team, as required.
• 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.
Audit Support:
• Maintain their processes at inspection readiness level and to provide the necessary support in any internal or external audit.

Additional Specifications:
• This role is a Wednesday-Saturday AM shift position. The role is for 4 days a week for 10 hours per day.Minimum requirements
Essential Requirements:
• Education: BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree. Desirable MSc. or equivalent experience
• Fluent in speaking / writing in English
• Minimum 3 years’ experience in GMP manufacturing role on the shop floor and/or QA/QC.
• Proven process understanding (Pharma, GMP, Regulatory aspects).
• 1 years of deviation/root cause analysis experience
Desirable Requirements:
• Cell & gene therapy experience is preferred

The pay range for this position at commencement of employment is expected to be between $80,000 and $120,000 per 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: 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: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: 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

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.

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: https://talentnetwork.novartis.com/network