Sr Engineer-Filling, Pivotal Drug Product Technologies

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. 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 Engineer-Filling, Pivotal Drug Product Technologies

What you will do

Let's do this. Let's change the world. As part of the Drug Product Technologies group, we are seeking a Senior Engineer for our Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late-stage drug product formulation and fill/finish process development for various biological modalities (large molecule, RNA, virus). Additionally, the position requires expertise in the field of aseptic processing and filling. The Sr. Engineer will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization process. The Sr. Engineer will need to stay ahead of the latest developments/trends in the industry and scientific community to foster innovation and to meet future business needs.

The Sr. Engineer will provide support for Amgen's biologics drug product and process design, commercialization and lifecycle management. The Sr. Engineer will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen's drug product and process development. The Sr Engineer will operate in a fast-paced, matrixed environment and collaborate successfully with colleagues within DPT and cross-functionally to develop and proceduralize lean study designs for process characterization, create and implement tools for data acquisition, analysis, and modeling, and improve operational efficiency via alignment of work across teams, and tailoring output to intended user requirements.

A successful candidate will be able to work independently, taking responsibility of projects and self-managing their work packages with appropriate communication and escalation. A successful candidate will thrive in a multi-functional team environment, adeptly collaborating and liaising with colleagues within the function, as well as partner organizations across Operations. Finally, a successful candidate will be driven to find efficient approaches to solve relevant problems and will thereby deliver value-adding and agile solutions to Amgen Process Development.

This position requires (up to 10%) travel to domestic and international sites

Responsibilities include:

• Partner with cross functional SMEs in the DP manufacturing network to complete Filling characterization, recipe development to enabling tech transfers and NPIs into the clinical and manufacturing network.
  
• Plan, design, execute, and document laboratory studies related to formulation, aseptic processing, visual inspection and fill/finish process development in support of product commercialization and life cycle management
  
• Collaborate across departments to drive process improvements, find opportunities, provide support and facilitate cross-site knowledge sharing.
  
• Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.
  
• Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
  
• Engage in the use and development of in-silico modeling tools.
  
• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
  
• Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs.
  
• Provide periodic support in the authorship of manuscripts, technical articles, departmental workshops and evaluation of offline capabilities.
  
• Ability to travel domestically and internationally up to 10% of the time.
  

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
  
• Master's Degree and 2 years of Engineering and/or Operations experience OR
  
• Bachelor's Degree and 4 years of Engineering and/or Operations experience OR
  
• Associate's degree and 8 years of Engineering and/or Operations experience OR
  
• High school diploma/GED and 10 years of Engineering and/or Operations experience
  

Preferred Qualifications:

• Experience with manufacturing unit operation (i.e. aseptic filling, filtration etc.)
  
• Experience in Fill recipe development using offline (Pilot) capabilities or in the manufacturing environment
  
• Proficiency in digital technologies and automation systems related to aseptic processing and filling operations, including experience with data analytics, process monitoring tools, and digital process control systems.
  
• Advanced degree in Engineering, Biotechnology, Pharmaceutics or related discipline with experience in pharmaceutical development and manufacturing.
  
• 2+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field.
  
• specific scale down model development, characterization, and scale-up.
  
• Strong problem solving and effective cross-functional communication skills.
  
• Experience that includes elements of new product development, aseptic processing, filling, manual / automated visual inspection, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments.
  
• Proven ability to learn and act on dynamic information at a rapid pace.
  

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, 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, including remote and hybrid work arrangements, where possible
  

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.

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.