Technical Transfer Lead (Ac-225 Focus)
Technical Transfer Lead (Ac-225 Focus)
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$ 114100 - 211900
1 Vacancy
Job Description
Job Description Summary
#LI-OnsiteLocation: Indianapolis Indiana
At Novartis we are pioneering the future of cancer treatment through Radioligand Therapy (RLT) - a powerful fusion of nuclear medicine and precision oncology. As we expand our global RLT manufacturing footprint we are seeking passionate purpose-driven individuals to join our mission of delivering life-changing therapies to patients around the world.
As the Technical Transfer Lead you will lead and execute technical activities for the actinium project at the site level (within inbound and outbound) including any scale-up or other process adaptations according to the project timeline. You will ensure process technology and product are efficiently transferred to the site. You will also act as the go-to person for MS&T related activities within the project during transfer and implementation. You will lead the technical transfer project team at the site and liaise with other sites and all involved functions (e.g. Technical Development Supply Chain Production Unit Quality Control HSE).
Job Description
Key Responsibilities:
- Review and update Quality Risk Assessment (QRA) prior to transfer and prior to validation adapt control strategy if needed. Provide technical expertise facilitate establishment of a product specific QRA.
- Review first APQR after transfer to ensure adequate product performance -Ensure that all relevant technical information and documentation for validation is available. Review subsequent APQRs and decide on state of control.
- Define and implement pre-validation / validation strategy including process cleaning packaging ongoing verification and supportive studies (e.g. hold times). Overall responsibility for establishment prioritization execution and tracking of Validation Master Plan. Coordinate technical regulatory and validation batches at site. Support Validation team in creation of validation protocol and report. Provide technical expertise for validation activities around technologies within area of responsibility.
- Maintain oversight and knowledge of the entire manufacturing process performed on site and throughout the entire commercial lifecycle act as SPOC.
- Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
- Interface with global MS&T network and Technical Development organizations for the corresponding global activities to define and implement new technical standards for existing and new technologies and equipment. Own the knowledge of specific pharmaceutical manufacturing process technologies locally including any pilot scale scale up or down and Design of Experiments (DoE).
- Harmonize and optimize technical processes across the site.
- Support Product Steward in maintaining the process control strategy.
- Lead complex projects with deep understanding of development process requirements.
Essential Requirements:
- BSc degree in Pharmacy Pharmaceutical Technology Chemistry or related field MSc. or equivalent relevant experience desirable.
- 8 years experience in the pharmaceutical industry including 3 years experience in radiopharmaceuticals especially isotope manufacturing.
- Comprehensive understanding of pharmaceutical technology and validation requirements and activities.
- Involvement with quality regulatory inspections of facilities from major agencies such FDA or EMA.
- Project management experience. Proven ability to plan and manage operational process to meet project timelines
- Excellent technical writing skills. Strong leadership skills
Desirable Requirements:
- Direct experience with low bioburden manufacturing
- Radiation safety education
The pay range for this position at commencement of employment is expected to be between $ 114100 and $ 211900 per 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.
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 or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$114100.00 - $211900.00Skills 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
