Senior Associate Manufacturing

Amgen Inc. (IR); Thousand Oaks (CA); On-site; USD 86,000 - 116,000; Full time

Job summary

Amgen in Thousand Oaks is seeking a Manufacturing Senior Associate to support manual visual inspection and manufacturing operations in the Drug Product Supply group. Under minimal supervision, you will perform unit operations in accordance with SOPs, analyze critical process parameters, and contribute to continuous improvement projects.

You should have GMP knowledge, experience with MES/LIMS/SAP/MAXIMO, and strong written/oral communication.

Qualifications

• Master’s degree or Bachelor’s degree with 6 months of biotech/pharma experience
• Associate’s degree with 2 years of biotech/pharma experience
• High school diploma with 4 years of biotech/pharma experience

Responsibilities

• Perform manufacturing unit operations per SOPs
• Schedule operations for multiple functional areas
• Analyze data for critical process parameters
• Identify process anomalies and contribute to improvements
• Support deviations/CAPA and quality systems

Skills

Lab equipment

GMP knowledge

Technical writing

Teamwork

Education

Master’s degree

Bachelor’s degree

Associate’s degree

High School Diploma

Tools

PAS X Werum

MAXIMO

LIMS

MES

SAP

Job description

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)


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


• 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.

Salary Range 86,048.05USD -116,417.95 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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.