Production Lead (Nights)

Healthcare Businesswomen’s Association; Indianapolis (IN); On-site; USD 77,000 - 143,000; Full time

Job summary

An established industry player is seeking Production Leads to join their dynamic team in isotope manufacturing. This pivotal role involves adhering to strict regulatory requirements, collaborating with management to ensure safe and efficient production, and maintaining high standards of quality and compliance. With a focus on continuous improvement and innovation, you will operate advanced isolators and participate in critical training and development activities. If you thrive in a fast-paced environment and are passionate about making a significant impact in pharmaceutical manufacturing, this opportunity is perfect for you.

Benefits

Health insurance

401(k)

Paid time off

Bonuses

Stock units

Qualifications

• 4+ years in pharmaceutical manufacturing, preferably low bioburden.
• Understanding of manufacturing and validation processes.
• Knowledge of cGMP and FDA regulations related to isotope manufacturing.

Responsibilities

• Operate and maintain grade C isolators, focusing on KPI goals.
• Support production readiness, including cleaning and sterilizing isolators.
• Prepare batch records, shipping documents, and training materials.

Skills

Change Control

Chemical Engineering

Continual Improvement

Efficiency

GMP

Lean Manufacturing

Process Control

Production Line

Root Cause Analysis

Technology Transfer

Education

Bachelor of Science degree

2 years of relevant experience in cGMP or aseptic environment

Tools

MS Office

Job description

Job Description Summary

Production Leads play an active role in daily isotope manufacturing, including setup and preparation of instruments and equipment. They adhere to regulatory requirements, execute production according to batch records and SOPs, and work within a team on assigned shifts. The role involves collaboration with the Production Manager and Shift Supervisor to ensure safe and timely production. This position will transition to night shifts in the future.

Job Description

Major accountabilities:

1. Operate and maintain grade C isolators, focusing on KPI goals and compliance with all radiation safety guidelines.
2. Complete training on SOPs, techniques, gowning, and safety protocols.
3. Support production readiness, including cleaning and sterilizing isolators.
4. Conduct environmental monitoring as required.
5. Maintain material identity and prepare materials per batch monitoring procedures.
6. Participate in qualification and validation activities.
7. Promote a culture of compliance and speaking up.
8. Prepare batch records, shipping documents, and training materials.
9. Participate in overtime to ensure process continuity.
10. Ensure technicians complete required training and participate in professional development.
11. Perform other duties as assigned.

Essential Requirements:

• Preferred: Training in radiochemistry or radiopharmacy.
• Minimum 4 years in pharmaceutical manufacturing, preferably low bioburden.
• Understanding of manufacturing and validation processes.
• Experience with new technology and process improvements.
• Knowledge of cGMP and FDA regulations related to isotope manufacturing.
• Proficient in MS Office.
• Ability to wear PPE and work in clean room environments.
• Visual acuity of 20/20 without impairments; corrective lenses permitted.
• Prohibited: Makeup, jewelry, nail polish, perfume in restricted areas.
• Ability to lift up to 35 pounds.
• Preferred: Bachelor of Science degree; if not, 2 years of relevant experience in cGMP or aseptic environment.

#LI-Onsite

Benefits and Rewards: Refer to the Novartis handbook for details. The salary range at start is $77,000 to $143,000 per year, subject to adjustments based on market, location, and experience. Compensation may include bonuses, stock units, and benefits such as health insurance, 401(k), and paid time off.

EEO Statement:

We are an Equal Opportunity Employer. Discrimination based on race, gender, age, or other protected categories is not tolerated.

Accessibility and accommodations:

We provide reasonable accommodations for individuals with disabilities. Contact us at [e-mail] or [phone] with your request and contact information, including the job requisition number.

Salary Range

$77,000.00 - $143,000.00

Skills Desired

Change Control, Chemical Engineering, Continual Improvement, Efficiency, GMP, Lean Manufacturing, Process Control, Production Line, Root Cause Analysis, Technology Transfer, and others.