Production Lead

Job Description Summary

Job Description

Key Responsibilities:

• Ensure batches are executed and records 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 associate are demonstrating proper aseptic behaviors and Good Documentation Practices on the Shop Floor. Provides innovative solutions to complex or process improvement issues.

• Support investigations and impact assessments for deviations.

• A self-motivated individual with a strong sense of ownership and discipline.

Essential Requirements:

• 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

OR:

• 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

• 2+ years of Novartis RLT manufacturing experience

AND:

• Strong interpersonal, written, communication skills along with problem solving and follow-up skills are 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 is 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

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 us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired