Job Description Summary

#LI-Onsite

This role is located on-site in Indianapolis, IN. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Quality Control professionals to help us reach our ambitious goals.

The Production Manager is responsible for overseeing the daily production process, coordinating all production activities and operations. Monitor the production processes and adjusts schedules as needed. Monitor productivity rates and product standards implement process improvement programs.

Job Description

Key Responsibilities:

Your responsibilities include, but are not limited to:

Responsible for the daily operations and efficient utilization of resources to meet processing demands.
Ensure the products are produced, inspected, stored and released in accordance with approved procedures.
Support shop floor trouble shooting and problem solving as needed.
Responsible for authoring, reviewing and/or approving GMP documents including but not limited to SOPs, Batch Records, Labels, Protocols, Reports, Validation documents.
Ensure Good Documentation Practice are followed on the shop floor.
Ensure production team receives complete cGMP training and are qualified to perform the required operations.
Support compliance activities including deviations, CAPAs, Investigation and OOS and OOT
Interview and hire production staff in conjunction with Production Support Leads and/or Head of Production.
Implement cost control programs or procedures.
Audit and review emergency paperwork and processes to ensure compliance.
Monitor and regulate staffing needs to ensure optimum staffing levels are supporting business demands.
Support a culture of safety, diversity and inclusion.

Shift: This role will be on a 4x10-hour shift schedule, Saturday - Tuesday. This position may involve mandatory overtime as needed.

Essential Requirements:

Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry preferred.
4+ years' experience in Aseptic/GMP manufacturing process support role in the pharmaceutical industry, experience with radiopharmaceuticals is preferred.
Good understanding or capacity to quickly understand production processes, scientific & technical (automation) understanding.
Change management, adaptability, ability to work under pressure.
Excellent organizational and time-management abilities.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. 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. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

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

$112,800.00 - $169,200.00

Skills Desired

Assembly Language, Biotechnology, Business Networking, Change Control, Chemistry, Continual Improvement Process, Cost Reduction, General Hse Knowledge , Incentive Program, Knowledge Of Gmp, Leadership, Lean Manufacturing, Learning And Development, Manufacturing Process, Manufacturing Production, Operations, Productivity, Risk Management, Root Cause Analysis (RCA), Six Sigma, Technology Transfer