Specialist Manufacturing Drug Product (DP) Operations

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.

Specialist Manufacturing - Drug Product Operations

What you will do

Lets do this. Lets change the world. At Amgen our missionto serve patientsdrives everything we do. As a Specialist Manufacturing in Drug Product (DP) Operations within the Production Process Owner (PPO) Team at our Thousand Oaks (ATO) manufacturing site you will play a key role in ensuring our commercial and clinical manufacturing processes are compliant efficient and continuously improving.

You will partner with cross-functional teamsincluding Engineering Quality Process Development and Operationsto implement process improvements support new technology introductions and maintain robust GMP manufacturing performance. Your work will directly contribute to Amgens ability to deliver life-changing therapies to patients worldwide.

Key Responsibilities:

Documentation and Process Management

• Initiate revise and approve controlled manufacturing documents within Amgens electronic document management system (CDOCs).

• Serve as document author owner reviewer or data verifier ensuring accuracy and compliance with current GMP and Amgen standards.

• Maintain documentation to accurately reflect operational practices and regulatory requirements.

Process Implementation and Project Execution

• Support implementation of new processes equipment and major initiatives within Drug Product operations.

• Collaborate with Capital Engineering Process Development Quality and other functions to define requirements and achieve operational readiness.

• Assist in developing and implementing SOPs batch records training validation and automation configurations.

Operational Performance and Data Analytics

• Analyze manufacturing data and performance metrics to identify trends deviations and opportunities for improvement.

• Develop and implement data-driven solutions to improve yield reliability and compliance.

• Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire ensuring configuration alignment with process design and GMP requirements.

Deviation and CAPA Management

• Support timely investigation and resolution of manufacturing deviations.

• Participate in root cause analyses (RCA) and human performance evaluations.

• Contribute to the development and implementation of effective corrective and preventive actions (CAPAs) and monitor CAPA effectiveness.

Validation and Process Control

• Assist in developing and implementing process validation protocols and reports.

• Collect analyze and interpret validation and process monitoring data to ensure process robustness and compliance.

• Support establishment of process parameters control limits and performance reporting.

Change Control and Continuous Improvement

• Support change control activities to ensure GMP regulatory and operational compliance.

• Evaluate and justify process or equipment changes and assist with project execution.

• Participate in continuous improvement and operational excellence initiatives to enhance safety quality and efficiency within DP operations.

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 individual with these qualifications.

Basic Qualifications:

• Doctorate degree OR

• Masters degree and 2 years of Manufacturing support experience OR

• Bachelors degree and 4 years of Manufacturing support experience OR

• Associates degree and 8 years of Manufacturing support experience OR

• High school diploma / GED and 10 years of Manufacturing support experience

Preferred Qualifications:

• Advanced degree (Masters or Ph.D.) in Engineering Biotechnology or related field

• Experience in aseptic Drug Product or biologics manufacturing

• Knowledge of process validation deviation management and change control

• Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire JMP Excel)

• Excellent written and verbal communication skills and ability to collaborate across functions

Competencies for Success

• Operational Excellence: Demonstrates attention to detail prioritizes quality and compliance and drives process improvements.

• Technical Expertise: Applies technical knowledge to evaluate troubleshoot and optimize manufacturing processes.

• Collaboration: Builds strong cross-functional relationships and fosters teamwork across disciplines.

• Accountability: Takes ownership of deliverables and ensures timely completion of commitments.

• Continuous Improvement: Identifies and implements opportunities to enhance manufacturing performance and reliability.

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 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.

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