Expert, Drug Supply
Expert, Drug Supply
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$ 77000 - 143000
1 Vacancy
Job Description
Band
Level 3Job Description Summary
Title: Clinical Lab Tech and Science SupportThis position will be located at East Hanover NJ site and will not have the ability to be located remotely.
Please note that this role would not provide relocation and only local candidates will be considered.
Provides input to developing validation strategy and coordinating validation activities required to complete assigned validation projects in support of the operation of the East Hanover NJ facility according to the corporate policies SOPs cGMPs QMs and international regulations. Provides technical support and services to the Quality Assurance Regulatory and Process Unit Departments.
#LIOnsite
Key Responsibilities:
Assist in maintaining the process control strategy. Translate applicable process parameters and the process control strategy into a focused validation plan for process validation.
Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).
Review Master Batch Records and assesses maintains and/or owns change controls.
Support Technology Transfer activities on as needed basis
Lead plan and maintain all activities related to aseptic processing validation with consultation of Associate Director Validation. Support routine and nonroutine Aseptic Process Validation activities by writing protocols and summary reports. Ensure that appropriate variables are identified for ongoing monitoring as a contributor to quality risk management activities.
Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV) / continued process verification (CPV) as applicable to enable late stage studies.
Author and review process process development aseptic processing validation and shipping validation protocols & reports ongoing process verification protocols/plans & reports.
Plan and support execution of validation activities on the floor.
Support Associate Director Validation for KPI reporting.
Maintain all activities and projects under own responsibility in an inspection ready status
Support evaluation of new and existing processes being transferred to or from the site by utilizing riskbased approach.
Job Description
Requirements:
- BSc. in Chemistry Pharmacy Chemical Engineering or Pharmaceutical Technology. Preferred
- 35 years experience in manufacturing/ manufacturing science and technology/technical development/quality.
- Thorough understanding of manufacturing processes and related process equipment.
- Strong working knowledge of quality systems and regulatory requirements across multiple health authorities.
- Experience in executing process validation.
- Expert in reviewing and writing technical documents.
- Proven project management experience in a crossfunctional environment (e.g. multisite
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $77000/year and $143000/ 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.
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 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 call 1 (877)and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Change Control Chemical Engineering Continual Improvement Process Efficiency Employment Discrimination Flexibility General Hse Knowledge Good Documentation Practice Knowledge Of Capa Knowledge Of Gmp Lean Manufacturing Manufacturing Process Manufacturing Production Physics Process Control Production Line Productivity Risk Management Root Cause Analysis (RCA) Scheduler Technology Transfer WellBeingEmployment Type
Full-Time
