Sr Engineer - Drug Product Pilot Plant

n them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr Engineer - Drug Product Pilot Plant

What you will do

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

In this role you will provide technical leadership to Amgen's parenteral drug product process design and commercialization. The candidate will lead off-line process characterization activities and work with global technology transfer team to transfer the process to clinical/ commercial fill finish lines with the aim of reducing or eliminating the onsite characterization work required. The candidate will also play a meaningful role in developing business cases for using the pilot plant capabilities further to serve the network, support development of in silico models to enable rapid, robust, process development.

Responsibilities include:

• Operate and trouble shoot filling equipment for characterization, special studies, and/or material generation to support the Amgen network

• Design, implement and document technical data packages related to drug product process design, development and characterization

• Meticulous review of protocols, and study design, to streamline execution and ensure successful implementation

• Support development of models and other data analytics tools for rapid process development and tech transfer

• Drive innovations in drug product process characterization and reduce pilot plant and clinical/ commercial GMP line time required for successful technology transfers and NPIs

• Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve issues, improve and develop new processes and evaluate effects of equipment changes, scale, and implementation of new raw materials

• Serve as an authority on manufacturing technologies (e.g. filling, automated visual inspection) and work with global multi-functional teams to develop and improve shared standard methodologies and technical advancements across Amgen clinical and commercial fill-finish plants

• Apply strong written and verbal communicational skills. Author technical protocols, reports and present findings and project status

• Contribute to and maintain a strong culture of safety and compliance in the plant

• Travel domestically and internationally may be required

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Engineering experience OR

• Associate's degree and 8 years of Engineering experience OR

• Bachelor's degree and 4 years of Engineering experience OR

• Master's degree and 2 years of Engineering experience OR

• Doctorate degree

Preferred Qualifications:

• Advanced degree in engineering, biotechnology, life sciences or related subject area

• 2+ years of experience in the pharmaceutical or biotechnology industry that includes elements of process development, process characterization, and technical transfers to manufacturing sites

• Advanced knowledge of biopharmaceutical manufacturing and business processes, and experience supporting GMP manufacturing operations

• Knowledge of, and hands-on experience with various drug product technologies related to fill-finish process (freeze-thaw, filtration, filling, isolators, visual inspection operations etc.)

• Ability to lead innovation, collaborate in a multi-functional team, and act on dynamic information at a rapid pace

• Ability to independently design and complete characterization studies, author characterization protocols, process transfer documents, and technical reports

• Proficiency in technical problem solving, critical thinking, and the delivery of technical solutions with limited oversight

• Capable of organizing and communicating technical concepts to enable business decisions

• Demonstrated skills in leading diverse multi-functional projects

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.

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.

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.

Salary Range
119,195.00 USD - 147,867.00 USD