Production Lead
Novartis
3 months ago
On-site
Millburn, NJ
Operations
Responsibilities:
- Direct daily operations for the Production Unit to produce and deliver high-quality product in a compliant, efficient, and cost-effective manner while maintaining safety.
- Ensure batches are executed and all applicable records are completed in compliance with cGMP.
- Author and review Standard Operating Procedures (SOPs) for production-related activities.
- Identify and implement process improvements with Production Management and Process Experts.
- Maintain an “audit ready” module; assist with internal pre-audits, cGMP housekeeping, and manufacturing space organization/upkeep.
- Assist the Production Manager with daily meeting communications and team organization for daily activities.
- Supervise training to ensure new hires have necessary technical skills and knowledge.
- Adhere to all SOPs, cGMPs, and safety rules/regulations.
- Ensure associates demonstrate proper aseptic behaviors and Good Documentation Practices on the shop floor; provide solutions to complex/process improvement issues.
- Support investigations and impact assessments for deviations.
Qualifications / Requirements:
- Bachelor’s degree in a STEM field preferred; if no degree, 2 additional years of experience in pharmaceutical cGMP or an aseptic environment are required.
- 3+ years of relevant pharmaceutical experience.
- 1+ years of experience on the shop floor.
- OR: 2+ years of Novartis RLT manufacturing experience.
Skills / Additional Requirements:
- Strong interpersonal and written communication; problem-solving and follow-up skills.
- Well organized, flexible, and able to work with minimal supervision.
- Knowledge of cGMP regulations and FDA guidance applicable to aseptic manufacturing.
- Ability to lift/carry up to 35 pounds.
- Ability to gown aseptically and work in a Grade C cleanroom for extended periods.
- Near vision equivalent to 20/20; no impairment of color vision (corrective lenses permitted).
- Previous radio pharma experience is a plus.
Benefits:
- Read our handbook (PDF 30 MB)
Application / Accommodation Instructions:
- For reasonable accommodations, contact [email protected] or call +1(877)395-2339 and include the job requisition number.
- Direct daily operations for the Production Unit to produce and deliver high-quality product in a compliant, efficient, and cost-effective manner while maintaining safety.
- Ensure batches are executed and all applicable records are completed in compliance with cGMP.
- Author and review Standard Operating Procedures (SOPs) for production-related activities.
- Identify and implement process improvements with Production Management and Process Experts.
- Maintain an “audit ready” module; assist with internal pre-audits, cGMP housekeeping, and manufacturing space organization/upkeep.
- Assist the Production Manager with daily meeting communications and team organization for daily activities.
- Supervise training to ensure new hires have necessary technical skills and knowledge.
- Adhere to all SOPs, cGMPs, and safety rules/regulations.
- Ensure associates demonstrate proper aseptic behaviors and Good Documentation Practices on the shop floor; provide solutions to complex/process improvement issues.
- Support investigations and impact assessments for deviations.
Qualifications / Requirements:
- Bachelor’s degree in a STEM field preferred; if no degree, 2 additional years of experience in pharmaceutical cGMP or an aseptic environment are required.
- 3+ years of relevant pharmaceutical experience.
- 1+ years of experience on the shop floor.
- OR: 2+ years of Novartis RLT manufacturing experience.
Skills / Additional Requirements:
- Strong interpersonal and written communication; problem-solving and follow-up skills.
- Well organized, flexible, and able to work with minimal supervision.
- Knowledge of cGMP regulations and FDA guidance applicable to aseptic manufacturing.
- Ability to lift/carry up to 35 pounds.
- Ability to gown aseptically and work in a Grade C cleanroom for extended periods.
- Near vision equivalent to 20/20; no impairment of color vision (corrective lenses permitted).
- Previous radio pharma experience is a plus.
Benefits:
- Read our handbook (PDF 30 MB)
Application / Accommodation Instructions:
- For reasonable accommodations, contact [email protected] or call +1(877)395-2339 and include the job requisition number.