Production Support Manager

Job Title: Production Support Manager 

Location: Remote, St. Louis, Missouri

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Reporting to External Manufacturing and Supply Large Molecule Site Operations Lead and ensuring on time & in full delivery by in person presence at the CMO

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

The Site Operations Leader will work:

In partnership

• External Manufacturing Site team, Specialty Care Functional Leadership

• Ensures on time & in full delivery of products for CMOs/External Suppliers (CMO facility is located in St. Louis, MO) within site management unit by being present at the contract manufacturing site during key manufacturing activities.

• Accountable to understand the products as it is implemented at the CMOs from an operational & financial perspective, able to provide routine technical support, and provide timely information to all stakeholders.

• Build collaborative business relationships with external partners as key partner to ensure on time & in full delivery by frequent presence at the CMO site.

• Serve as the first level of escalation to the External Manufacturing Product Teams as it relates to problems encountered with CMO activities & production.

• Actively participates in CMO driven Joint Steering Committee (JSC) meetings. 

• Escalates issues to appropriate forums, as needed.

• Accountable to understand the contract guidelines and the impact to the product/departmental P&L of production variations.

• Responsible for implementing Life Cycle management projects.

• Responsible for the adherence to the Risk Management Program to identify, evaluate, document, and communicate risks potentially impacting quality and compliance; involves a multi-disciplinary team to define remediation plans to mitigate risks impacting products and GxP operations.

• Ensure Compliance through active participation at all applicable quality governance forums (including Quality Management Reviews and Periodic Business Reviews).

• Accountable for reviewing and providing technical of critical deviations.

• Accountable for on time Quality System related records, also reviews and approve all Category 3 Change Requests.

• Interface with external regulatory authorities as required.

• Works with EST, EMPT leads and Functional heads for standardization of processes and procedures required to manage CMOs and related work within External Site Team.

About You

Experience:

• Bachelor’s degree with scientific background or equivalent and 8+ years of experience

• Master’s degree with scientific background or equivalent and 5+ years of experience

• Experience in operational roles

• Strong quality mindset

• Knowledge/understanding of supply chain logistics