Senior Engineer Internal Process Engineering

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

What you will do

Lets do this. Lets change the this vital role you will join Amgens Drug Product Process Engineering team within the Drug Product Technologies organization. Reporting to the Principal Engineer or Sr. Manager of Process Engineering this role will support the development implementation and continuous improvement of drug product processes across Amgens parenteral portfolio. The Senior Engineer will contribute technical expertise to support evolving business needs industry trends and stakeholder priorities.

This role will be based in Thousand Oaks CA or Cambridge MA to ensure effective technology transfer support to our commercial drug product manufacturing plants. Some US and international travel may be required to support Amgens global drug product network.

The Senior Engineer will operate in product and process development and/or manufacturing environments supporting the design and execution of process characterization studies and evaluating the impact of manufacturing process parameters production scale equipment and raw material changes on product quality. The role will contribute to the preparation of high-quality technical documentation including process technology transfer documents study reports and technical assessments and may support the development of relevant sections of regulatory submissions to enable successful introduction of new processes and/or production facilities.

You will work closely with clinical and commercial manufacturing teams to support ongoing production new product introductions new technology implementation and process optimization efforts. The Senior Engineer will apply fundamental scientific principles (e.g. biochemistry biophysics statistics) and engineering principles (e.g. equipment automation chemical mechanical engineering) to support investigations of non-conformances and the development of corrective and preventive actions.

As a key technical contributor to Amgens commercialization and process transfer activities the Senior Engineer will collaborate with cross-functional teams including engineering analytical sciences quality regulatory and manufacturing. This role will integrate technical knowledge and data from multiple sources to support robust process unders

• Lead or support commercial technology transfers by executing make-a-batch assessments to determine facility fit designing and executing offline and on-site characterization studies authoring high-quality process transfer documentation providing on-site support and evaluating potential product impacts due to process scale equipment and raw material changes.
• Work collaboratively with a team of process scientists and engineers to design implement and document process development and technology transfer activities generating primary data packages while applying expertise in aseptic processing equipment automation and unit operation characterization.
• Serve as a drug product technical specialist providing solutions for parenteral manufacturing across unit operations including but not limited to formulation sterile filtration filling capping lyophilization and visual inspection.
• Support continuous improvement in drug product development and manufacturing through application of first principles in process engineering and by leveraging data-driven approaches including advanced data analytics modeling and emerging AI-enabled tools to enhance process understanding and robustness.
• Support technology transfers for pipeline and commercial products and contribute to lifecycle management activities across a range of parenteral modalities.
• Deliver clear progress reports and technical presentations to management and project teams to communicate status risks and key findings and escalate issues or unresolved technical challenges through appropriate governance channels.
• Participate in global cross-functional teams working effectively within a highly matrixed environment to advance programs through clinical manufacturing and commercialization.
• Build and sustain strong relationships with drug product development teams and manufacturing partners to ensure alignment between program needs process requirements and site capabilities.
• Apply fundamental scientific (biochemistry biophysics statistics) and engineering principles (equipment automation chemical mechanical) to support process characterization scale-up and troubleshooting activities.
• Explore and implement opportunities to utilize digital and AI-enabled approaches for process

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 a self-starter with these qualifications.

Basic Qualifications:

• Doctorate degree
• Or
• Masters degree and 2 years of Operations or Process Development experience
• Or
• Bachelors degree and 4 years of Operations or Process Development experience
• Or
• Associates degree and 8 years of Operations or Process Development experience
• Or
• High school diploma / GED and 10 years of Operations or Process Development experience

Preferred Qualifications:

• M.S. or PhD in Chemical/Biomedical Engineering Pharmaceutical Sciences Chemistry/Biochemistry or Biotechnology or related field
• 5 years of drug product process development experience in the pharmaceuticals/biotechnology industry
• Familiarity with aseptic processing drug product manufacturing drug product manufacturing cGMPs statistical design analysis of experiments and process characterization
• Process scale-up and technology transfer experience including the use of gap analysis root cause analysis and risk assessment tools
• Knowledge of bringing new products to market across various dosage forms and delivery systems
• Knowledge of associated GMP/Device documentation and regulatory filings
• Experience with conducting statistical evaluations of data to evaluate statistical significance assess potential correlations evaluate process capability and/or perform Monte Carlo simulations.
• The ability to use engineering principles to demonstrate bench and pilot scale models for process performance characterization
• Familiarity with the application of AI-enabled tools to support process characterization process monitoring and data-driven decision making in drug product development and manufacturing.
• Experience in a matrix team environment in particular interacting with Attribute Sciences Process Development Project Management Manufacturing Regulatory Compliance and/or Quality
• Interpersonal communication and facilitation skills necessary to represent functional position and forge consensus among competing client interests while ensuring objectives are met
• Ability to learn and act on dynamic information at a rapid pace
• Ability to travel domestically and internationally up to 25% of the time

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 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.

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