Manufacturing Specialist
Manufacturing Specialist
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$ 77000 - 143000
1 Vacancy
Job Description
Job 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 (RLT) to cancer patients.As a Manufacturing Specialist you will provide front line support to manufacturing working with the production teams to ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements. You will act as our Subject Matter Expert (SME) for product and process knowledge and will be the first point of contact for product and process related issues. You will drive investigations to true root cause and ensure implementation of corrective and preventive actions.
NOTE: This role will support our new Isotopes Manufacturing facility. Shift hours and schedule will evolve as we move from start up to business as usual.
Periodic mandatory overtime may be necessary to ensure process continuity and completion.
Job Description
Key responsibilities:
- Manage and maintain manufacturing documentation including Master Batch Records applicable SOPs risk assessments protocols shipping documents training materials and other documentation.
- Technical writing/Reviewing to support manufacturing operations including but not limited to Standard Operating Procedures (SOP) batch records and white papers.
- Collect data for ongoing process verification (OPV) support tracking and evaluation of product performance and implementation of CAPAs.
- Author and own investigations related to material transfer isotope manufacturing and packaging.
- Ensure processes remain inspection ready at all times. Support process optimization and new technology introduction for continued productivity improvement as appropriate.
- Review validation protocols and reports. Support the execution of process validation and short-term improvement projects. Participate in assigned qualification/validation activities as necessary.
- Provide guidance and support to production team through training and knowledge leadership capabilities and guide processes to closure/completion.
- Facilitate a speak up culture and ensure all cGMP compliance activities are followed.
- Ability to don clean room garments and personal protective equipment (PPE).
- Ability to lift or carry up to 35 pounds.
Essential Requirements:
- Bachelors degree in Engineering Pharmacy Pharmaceutical Technology Chemistry or relevant experience in lieu of degree and 3 years experience in a process support shop floor role in GMP manufacturing and/or QA/QC.
- Strong awareness of quality issues. Compliance investigations experience required.
- Good understanding of manufacturing and validation requirements and activities.
- Ability to utilize new technology and techniques to eliminate non-value adding activities and improve productivity / performance through new processes.
- Proficient in MS Office applications.
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Desirable Requirements:
- Training in radiochemistry or radio pharmacy is preferred.
- Knowledge of cGMP regulations and FDA guidance applicable to radioligand therapy or isotope manufacturing.
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The pay range for this position at commencement of employment is expected to be between $770000 and $ 143000per 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
$77000.00 - $143000.00Skills 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 Well-BeingRequired Experience:
Unclear Seniority
Employment Type
Full-Time
