Senior Associate Manufacturing CAPAEV

Career Category

Job Description

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.

Senior Associate Manufacturing (CAPA/EV)

What you will do

Lets do this. Lets change the this vital role you will support deviations by owning the associated CAPA and EV records in the Amgen Thousand Oaks Manufacturing Clinical Supply Organization including Drug Substance and Drug Product manufacturing Supply Chain Drug Product Assembly/Packaging Quality Control and Warehouse Operations. This individual will play an integral role collaborating within a cross-functional team that includes Manufacturing Quality Assurance Process Engineering Process Development Analytical Sciences Quality Sciences Quality Control Supply Chain and Regulatory Affairs.

Responsibilities:

• Manage deviation investigation CAPAs and EVs including assembling teams and compliant documentation of all findings.

• Drive improvements to the investigation process

• Defend investigation CAPAs/EVs to regulatory inspectors and internal auditors

• Present complex topics clearly to large and small groups at all levels in the company

• Build effective relationships across functions

• Clear and concise technical writing

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:

• Masters degree OR

• Bachelors degree and 6 months of manufacturing experience OR

• Associates degree and 2 years of manufacturing experience OR

• High school diploma / GED and 4 years of manufacturing experience

Preferred Qualifications:

• 4 years related work experience (manufacturing process development or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility

• Degree in Science or Engineering

• Experience leading teams

• Demonstrated project management ability

• Excellent written and verbal communication skills

• Ability to work in a team matrix environment and build relationships with partners

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:

• A 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

• Flexible work models including remote and hybrid work arrangements where possible

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

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

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.

Salary Range