Production Lead

Key Responsibilities

• Ensure batches are executed and record all applicable data in compliance with cGMP expectations.
• Author and review Standard Operating Procedures that pertain to Production-related activities.
• Engage with Production Management and Process Experts to identify and implement process improvements within areas of expertise.
• Maintain an “audit ready” module. Assist with internal pre-audits walkthroughs, cGMP housekeeping and general organization and upkeep of manufacturing spaces.
• Assist Production Manager with communication of job-related information during daily meetings and organize the team for daily activities.
• Supervise training to ensure new hires have necessary technical skills and knowledge.
• Adhere to all SOPs, cGMPs, and safety rules and regulations.
• Ensure associates are demonstrating proper aseptic behaviors and Good Documentation Practices on the Shop Floor. Provide innovative solutions to complex or process improvement issues.
• Support investigations and impact assessments for deviations.
• Be a self-motivated individual with a strong sense of ownership and discipline.

• Bachelor’s degree in a STEM field (Science, Technology, Engineering & Math) is preferred; if the applicant does not have a degree, 2 additional years of experience in pharmaceutical cGMP or aseptic environment is required beyond the below years.
• 3+ years of relevant pharmaceutical experience.
• 1+ years of experience on shop floor.
• 2+ years of Novartis RLT manufacturing experience (or equivalent).
• Strong interpersonal, written, communication skills along with problem solving and follow-up skills required.
• Must be well organized, flexible and work with minimal supervision.
• Knowledge of cGMP regulations and FDA guidance applicable to aseptic manufacturing.
• Ability to lift or carry up to 35 pounds.
• Ability to gown aseptically and work in a clean room environment (Grade
  
  C) area for extended periods of time required.
• 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.
• Previous Radio pharma experience a plus.

• Entry level

• Full-time

• Management and Manufacturing
• Pharmaceutical Manufacturing