Production Lead, Weekend Days
Novartis
3 months ago
On-site
Indianapolis, IN
Operations
Responsibilities:
- Execute all activities related to manufacturing RLT isotope products, including operating and maintaining grade C isolators.
- Ensure compliance with state, federal, and applicable radiation safety guidelines and cGMP requirements.
- Complete required training curriculum on time, including SOPs/techniques, gowning qualifications, role-specific HSE, and other relevant training.
- Support production readiness by manually cleaning cells and sterilizing isolators.
- Conduct routine and dynamic environmental monitoring as required.
- Prepare materials while maintaining material identity per the batch monitoring system/procedure.
- Participate in assigned qualification/validation activities.
- Prepare and maintain applicable documents/records (e.g., batch records, shipping documents, training materials).
- Ensure technicians complete required training per the published curriculum.
- Facilitate a “speaking up” culture and support technician professional development.
- Participate in periodic mandatory overtime to ensure process continuity and completion.
- Other duties as assigned.
Qualifications (Minimum Requirements):
- Bachelor of Science strongly preferred; otherwise, minimum 2 years’ experience in a cGMP or aseptic environment.
- Training in radiochemistry or radio pharmacy preferred.
- 4+ years of pharmaceutical manufacturing experience; low bioburden manufacturing preferred.
- Good understanding of manufacturing and validation requirements/activities.
- Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
- Ability to don cleanroom garments and PPE.
- Near vision equivalent to 20/20 with no color vision impairment (corrective lenses permitted).
- No makeup/jewelry/nail polish/perfume/cologne or other potential microbial sources in restricted areas.
- Ability to lift/carry up to 35 pounds.
Shift:
- Weekend days, 12 hours
- Execute all activities related to manufacturing RLT isotope products, including operating and maintaining grade C isolators.
- Ensure compliance with state, federal, and applicable radiation safety guidelines and cGMP requirements.
- Complete required training curriculum on time, including SOPs/techniques, gowning qualifications, role-specific HSE, and other relevant training.
- Support production readiness by manually cleaning cells and sterilizing isolators.
- Conduct routine and dynamic environmental monitoring as required.
- Prepare materials while maintaining material identity per the batch monitoring system/procedure.
- Participate in assigned qualification/validation activities.
- Prepare and maintain applicable documents/records (e.g., batch records, shipping documents, training materials).
- Ensure technicians complete required training per the published curriculum.
- Facilitate a “speaking up” culture and support technician professional development.
- Participate in periodic mandatory overtime to ensure process continuity and completion.
- Other duties as assigned.
Qualifications (Minimum Requirements):
- Bachelor of Science strongly preferred; otherwise, minimum 2 years’ experience in a cGMP or aseptic environment.
- Training in radiochemistry or radio pharmacy preferred.
- 4+ years of pharmaceutical manufacturing experience; low bioburden manufacturing preferred.
- Good understanding of manufacturing and validation requirements/activities.
- Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
- Ability to don cleanroom garments and PPE.
- Near vision equivalent to 20/20 with no color vision impairment (corrective lenses permitted).
- No makeup/jewelry/nail polish/perfume/cologne or other potential microbial sources in restricted areas.
- Ability to lift/carry up to 35 pounds.
Shift:
- Weekend days, 12 hours