Production Lead (Nights)
Production Lead (Nights)
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$ 77000 - 143000
1 Vacancy
Job Description
Job Description Summary
Production Leads play an active role in daily production of isotope manufacturing as well as setup and preparation of instruments and equipment. The Production Lead adheres to regulatory requirements while performing job functions executing production as per batch records and SOPs. Responsibilities are performed within a team and according to an assigned production shift schedule. The Production Lead works closely with the Production Manager and Shift Supervisor to ensure production is executed in a safe and timely manner. This role will transition to night shifts in the future.Job Description
Major accountabilities:
- Executes all activities related to the manufacturing of RLT isotope products. Responsibilities include operating and maintaining grade C isolators focusing on KPI goals as well as ensuring all state federal and Novartis radiation safety guidelines are adhered to.
- Responsible for successful on time completion of required training curriculum comprising of the necessary Standard Operating Procedures (SOPs) and Techniques Gowning Qualifications and other relevant training including HSE for the specific role.
- Supports all technical aspects related to production readiness including manually cleaning the cell and performing sterilization of the isolators.
- Conducts routine and dynamic environmental monitoring as required.
- Prepares all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure.
- Participation in assigned qualification/validation activities as necessary.
- Facilitates a culture of speaking up and ensuring all cGMP compliance activities are followed.
- Prepares applicable documents and records such as batch records shipping documents and training materials.
- Participates in periodic mandatory overtime to ensure process continuity and completion.
- Ensures technicians complete all required training in accordance with published curriculum.
- Participate in technician professional development counselling to foster a growth culture.
- Other duties may be assigned as necessary.
Essential Requirements:
- Training in radiochemistry or radio pharmacy is preferred.
- 4 years of experience in pharmaceutical manufacturing with low bioburden manufacturing preferred.
- Good understanding of manufacturing and validation requirements and activities.
- Exploitation of new technology and techniques to eliminate non-value adding activities and improve productivity / performance through new processes.
- Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
- Proficient in MS Office applications.
- Flexibility to don clean room garments and personal protective equipment (PPE).
- Near vision performance should be the equivalent of 20/20 with no impairment of color vision. The use of corrective lenses to achieve the desired visual acuity is permitted.
- Makeup jewelry nail polish perfume/cologne and other potential microbial sources are prohibited in restricted areas.
- Ability to lift or carry up to 35 pounds.
- Bachelor of Science strongly preferred. If the applicant does not have a degree a minimum of 2 years of experience in a cGMP or aseptic environment can be substituted
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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-BeingEmployment Type
Full-Time
