Manager Manufacturing - Drug Product at Amgen

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Manager Manufacturing - Drug Product

Live

What you will do

Lets do this! Lets change the world!

The Amgen Thousand Oaks, Building 20 Drug Product Manufacturing facility directly supports Amgens pipeline of clinical & emerging commercial 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 leading a team of experienced 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, contribute to production scheduling decisions, and work cross-functionally to close nonconformance investigations and introduce new product SKUs.

Additional Responsibilities:

• Staff selection, training, oversight, performance evaluations, 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 carrying out 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 advised.

• Interacting 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 implement both near-term schedule and long-term strategy.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

• Doctorate degree OR

• Masters degree and 3 years of drug product manufacturing or operations experience OR

• Bachelors degree and 5 years of drug product manufacturing or operations experience OR

• Associates 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 experience directly within drug product manufacturing that includes aseptic and sterile filling environments

• Bachelor's or Master's degree in Microbiology, Life Sciences, Business or a related field

• Strong working knowledge of lean concepts and application within a regulated manufacturing environment

• Effective at working in fast-paced environments, specifically in a leadership capacity to facilitate objective decision making

• Diagnostics of automated process equipment

• Process optimization

• Equipment installation and validation.

• Knowledge and understanding of precision instrumentation and control systems

• Assist with operational readiness of new machinery through understanding of wiring, pneumatic, assembly, process, and machine part diagrams to ensure operational success.

• Equipment safety training experience

• Successful 3D design and 3D printing

• Extensive Bausch+Strbel equipment knowledge

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.