Head Of Production, Carlsbad

About the Role

Location: Carlsbad, CA

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 a dynamic Manufacturing leader with prior pharmaceutical industry experience in a sterile environment to help us reach our ambitious goals.

As the Head of Production, you will be responsible for leading the manufacturing operations unit in our new Radioligand Therapy (RLT) Production Facility and achieving site objectives in all areas, including Safety, Supply, Cost, Quality, and People. You will identify and implement programs and actions to ensure sustainable and reliable execution of manufacturing operations in alignment with cGMP regulatory expectations at the Carlsbad Site.

This role reports directly into the Site Head and will also be part of the Site Leadership Team.

Key Responsibilities:

• Establish and maintain the production unit in full cGMP and HSE (Health, Safety and Environmental) compliance. Optimize workflows and methods/procedures for manufacturing. Lead preparations for commercial launch, including commissioning and qualification of rooms and equipment.

• Responsible for site Production Budget planning, execution, and adherence.

• Partner with Supply Chain on production plan and deliver 100% On-Time-In-Full deliveries.

• In collaboration with Quality and Engineering, make decisions with respect to batch disposition, investigation of out of trend or out of specification results, deviations, change control, and corrective and preventative actions. Perform analysis of trends in deviations and other events and facilitate resolution defining action plans.

• Lead or assist in all projects related to site improvements at the local or global level. Support site launches of manufacturing products. Analyze Key Performance Indicators (KPIs) with a statistical mindset to identify opportunities for improvement.

• Prepare for and participate in Health Authority inspections and internal audits. Ensure Production personnel are qualified, and manufacturing is properly conducted and documented for all performed activities. Evaluate and approve Production records as required.

• Recruit, train, and develop competent, high performing team members and maintain a robust succession plan. Help promote an unbossed culture supporting ownership, innovation, speak-up, and accountability.

Diversity & Inclusion / EEO

We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

• Novartis: e-mail [email protected] or call +1 (877)395-2339

• Sandoz: e-mail [email protected] or call: +1-609-422-4098

Role Requirements

Essential Requirements:

• BS degree in engineering, chemistry, pharmacy, or related field; or 4 years of relevant experience in lieu of a degree.

• 8 years of experience in the pharmaceutical industry including direct experience with sterile manufacturing and at least 3 years of leadership experience.

• Prior involvement with quality regulatory inspections of facilities from major agencies such FDA or EMA.

• Excellent technical writing skills.

• Proven ability to plan and manage operational processes for maximum efficiency and productivity.

• Strong leadership skills - communication, cross-functional collaboration, problem solving.

Desirable Requirements:

• Training in radiochemistry or radio pharmacy

• Radiation safety education

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the -most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/people-and-culture.

The pay range for this position at commencement of employment is expected to be between $144,000.00 and $216,000.00 per year; however, while salary ranges are effective from 1/1/24 through 12/31/24 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards.

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 in order to perform the essential functions of a position, please send an e-mail to [email protected] 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.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: Novartis Talent Pool.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?