Product Steward
Product Steward
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$ 114100 - 211900
1 Vacancy
Job Description
Band
Level 4Job Description Summary
At Advanced Accelerator Applications a Novartis company we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Manufacturing professionals to help us reach our ambitious goals.The Product Steward owns the process knowledge of the product(s) assigned throughout the commercial lifecycle maintains the oversight on process capability through data trending and statistical analysis of critical variables ensuring process(es) are robust in continued state of validation and continuously improving.
This role is located onsite in Millburn NJ. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
Location: Onsite
Job Description
Major accountabilities:
Technical Transfer Lead Review and update Quality Risk Assessment (QRA) prior to transfer and prior to validation adapt control strategy if needed.
Review first APQR after transfer to ensure adequate product performance Ensure that all relevant technical information and documentation for validation is available.
Define prevalidation / validation strategy incl. process cleaning packaging and supportive studies (e.g. hold times).
Coordinate technical regulatory and validation batches at site.
Support Validation Lead / Validation Expert in creation of validation protocol and report.
Product Steward And Maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle since transfer from development to date act as SPOC.
Create and maintain a product specific Quality Risk Analysis (QRAs).
Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
Review APQR and decide on state of control.
Technical Steward Act as the SPOC for the interface with global MSAndT network and with technical development organization for the corresponding global activities to define and implement new technical standards for existing and new technologies and equipment.
Owns the knowledge of specific pharmaceutical manufacturing process technologies locally including any pilot scale scale up or down and Design of Experiments (DoE).
Provide technical expertise for validation activities around technologies within area of responsibility.
Harmonize and optimize technical processes across the site.
Validation Lead Support Product Steward in maintaining the process control strategy.
Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).
Define and implement validation strategy (process cleaning ongoing verification) and defend to authorities.
Overall responsibility for establishment prioritization and tracking of Validation Master Plan for process cleaning packaging validation and ongoing process verification (OPV) ongoing cleaning verification.
Senior Scientist MSAndT Complex projects with deep understanding of development process requirements Difficult to solve topics (i.e. new byproduct investigation complex deviations) Cross product alignment in support approach (larger sites) Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt Distribution of marketing samples (where applicable)
The pay range for this position at commencement of employment is expected to be between $108500 to $201500 a 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 signon 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 atwill 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.
Minimum Requirements:
- Bachelors Degree in Sciencerelated field
- 5 years of relevant GMP experience
- Previous pharmaceutical experience
- Knowledge of CAPA and Quality Change Control
Benefits and rewards: Read our handbook to learn about all the ways well help you thrive personally and professionally: 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 our Novartis Network:Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: 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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. 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
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 email to calland let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Applied Statistics Assembly Language Change Control Chemical Engineering Continual Improvement Process Cost Reduction Data Analytics Electronic Components General Hse Knowledge Including Gdp Knowledge Of Capa Knowledge Of Gmp Lean Manufacturing Manufacturing Process Manufacturing Production Manufacturing Technologies Process and Cleaning Validation Process Control Process Simulation Risk Management Root Cause Analysis (RCA) Scientific Method Six Sigma Statistical Analysis Technology TransferEmployment Type
Full-Time
Key Skills
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