Manufacturing Manager- Fill

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Manufacturing Manager- Fill

What you will do

Let’s do this. Let’s change the world. In this vital role you will directly support Amgen’s pipeline of clinical drug product supply to patients across the globe. The Manager Manufacturing – Drug Product role offers the opportunity to collaborate with multiple functions within the Thousand Oaks site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, Regulatory Compliance, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility. The Manager Manufacturing is responsible for developing a team of expert manufacturing associates and technicians within Drug Product operations, while championing a safe and compliant production environment through structured on-floor presence.In this position, the manager will ensure production areas and procedures remain in compliance with current Good Manufacturing Practices, set and measure team performance/goals, chip in to production scheduling decisions, and work cross-functionally to close nonconformance investigations and introduce new product skus.

Responsibilities:

• Staff selection, training, oversight, performance, and development.
• Schedule adherence for tasks including, but not limited to manufacturing, qualification, and maintenance activities.
• Participating as a role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor.
• Elevating critical and impactful events to senior management and make real time processing decisions.
• Ensuring standard operating procedures are accurate for performing unit operations, batch record review is completed accurately meeting disposition timelines, and non-conformances are initiated & closed with right the first time documentation
• Using appropriate systems for job duties (SAP, QMTS, and LIMS etc.). Identifies and implements process and safety improvements. Communicate production floor and project work at different levels of management.
• Interacting with business partners and internal/external audit teams including regulatory agencies as required.
• Working with business partners to assist with scheduling of maintenance tasks, engineering evaluations, and quality investigations.
• Supporting the introduction of new products and technologies into the facility. Troubleshoot and perform initial assessment of events that have the potential to impact area safety and product quality.
• Assessing departmental utilization to complete both near-term schedule and long-term strategy.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 3 years of drug product manufacturing or operations experience

Or

Bachelor’s degree and 5 years of drug product manufacturing or operations experience

Or

Associate’s degree and 10 years of drug product manufacturing or operations experience

Or

High school diploma / GED and 12 years of drug product manufacturing or operations experience

In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• At least 10 years of biopharmaceutical experience, with 3 years of leadership experience dir