Aseptic Officer

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.

Aseptic Officer

What you will do

Lets do this. Lets change the world. In this vital role you will provide technical leadership and oversight of aseptic operations within the multi-product drug product manufacturing facility. This role is accountable for maintaining compliance with cGMP requirements through robust execution of the aseptic technique and media fill programs and by supporting contamination control initiatives across operations. You will own the Media Program for one of two isolator-based filling lines, lead observation and training efforts to sustain aseptic compliance, and partner cross-functionally with Quality, Validation, and Engineering to ensure sterility assurance standards are consistently met.

Responsibilities :

Aseptic Program Leadership

• Lead the Aseptic Technique Program for the suite, including routine observation of critical operations, data trending, and implementation of corrective and preventive actions (CAPAs).
• Provide coaching and mentoring to operations personnel to strengthen aseptic practices and contamination control awareness.
• Author, review, and maintain aseptic-related SOPs, reports, and training materials to ensure alignment with current regulatory expectations and site standards.
• Partner closely with Quality Assurance, Validation, and other site Aseptic Officers to ensure consistent execution and knowledge sharing across functions.
• Represent Manufacturing during internal and external inspections, demonstrating robust understanding and control of aseptic practices.

Media Fill Program Ownership

Contamination Control and Compliance Support

Operational Excellence

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.

Basic Qualifications :

Doctorate degree

Or

Masters degree and 2 years of operations or quality experience

Or

Bachelors degree and 4 years of operations or quality experience

Or

Associates degree and 8 years of operations or quality experience

Or

High school diploma / GED and 10 years of operations or quality experience

Preferred Qualifications :

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include :

Apply now and make a lasting impact with the Amgen team.

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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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.