Senior Associate Manufacturing

Career Category

Manufacturing

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. 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.

Senior Associate Manufacturing

What you will do

Let’s do this! Let’s change the world!

The Manufacturing Senior Associate position is part of the Amgen, Thousand Oaks, Drug Product Supply organization. This is a manufacturing support role responsible for manual visual inspection team. This Senior Associate position will be focused on:

Characterization, data, and equipment management

Process improvement projects/assignments within operations

Quality systems (Deviations/CAPA/CAPA EV/LIMS/MES/SAP/MAXIMO) support

Support new product introduction activities

Support production

Maintain open communication between operations teams

This Senior Associate position will be focused on manual visual inspection operations.

Job Scope and Responsibilities:

Under minimal supervision, performs manufacturing unit operations according to Standard Operating Procedures

May schedule operations for multiple functional areas

Understand process parameters and can identify process anomalies

Perform data analysis of critical process parameters

Operate complex critical processing equipment

Assist, plan and implement continuous improvement solutions related to routine functions

Assist in ensuring operations are completed per manufacturing schedule which may include delegation of tasks

Primary resource related to processing operations on the mfg. floor

Identify and propose solutions to complex problems

Responsible for resolving problems during operations

Perform initial review of manufacturing procedures/batch records

Review, revise, and audit documents

Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)

Provide process theory expertise and hands-on training to others

Own deviations/CAPA or provide suggestions/ideas for corrective actions and preventative actions for deviations/safety incidents

Applies research, information gathering, and interpretation skills to problems of diverse scope

Utilizes project management skills to set project timelines and priorities based project objectives and ongoing assignments

Recognizes and escalates problems

Able to establish working relationships with others outside area of expertise

Ability and willingness to support flexible shift structure in support of operations (may include 24/7 or weekend)

Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles as appropriate for the position

Organizational skills and an ability to perform assignments with a high degree of attention to detail

Written and oral communication skills. Technical writing capability

GMP knowledge with ability to interpret and apply applicable regulations

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:

Master’s degree OR

Bachelor’s degree and 6 months of experience in biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) OR

Associate’s degree and 2 years of experience in biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) OR

High School Diploma/GED and 4 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)

Preferred Qualifications:

Prior experience with lab equipment, computers, and intermediate mathematical skills

Significant experience with manual visual inspection in a GMP regulated environment.

Significant experience with PAS X Werum software for electronic batch records with some understanding of editing and validation

Degree in Engineering, Chemistry, Biochemistry, Biology or Computer Science with experience in biotechnology

Demonstrated technical writing skills

Strong knowledge of manual visual inspection or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)

Demonstrated ability to work in a team

What you can expect of 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, we’ll 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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

careers.amgen.com

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 es