Senior Engineer, Process Development (Downstream)

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.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbon-neutral company by 2027.

Senior Engineer Process Development (Downstream)

What you will do

Lets do this. Lets change the this vital role you will advance Amgen latest bioprocessing platform and technology delivering high quality of medicine to patients around the world.

The Sr. Engineer will be part of the Process Development-Drug Substance Technology at Amgens FleX Batch facility focusing on technology transfer process support and optimization. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility which includes collaborating with other drug substance teams across our network.

Responsibilities include but are not limited to:

• Support technology transfer process validation and plant start-up
• Provide technical leadership in Downstream (Purification) Bioprocessing for process monitoring optimization yield improvement complex investigation and product life cycle management
• Partner with cross-functional teams to resolve complex problems while meeting quality schedule and cost objectives
• Provide on-the-floor process support as required
• Ensure safety and compliance of process development activities
• Collaborate with other site-functions and network drug substance teams in delivering plant goals
• Support regulatory filing inspection and other CMC activities

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The inspiring professional we seek is a strong team-player with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of biologics process development or commercial-scale technical support experience OR
• Associates degree and 8 years of biologics process development or commercial-scale technical support experience OR
• Bachelors degree and 4 years of biologics process development or commercial-scale technical support experience OR
• Masters degree and 2 years of biologics process development or commercial-scale technical support experience OR
• Doctorate degree

Preferred Qualifications:

• Masters degree in Engineering or Science discipline
• 5 years of experience in a technical role supporting biotechnology processes within regulated environments (i.e. cGMP)
• In-depth expertise in biologics process purification processes
• Experience in process scale-up technology transfer process validation process optimization troubleshooting and complex investigation
• Strong oral and verbal communication skills interact effectively with diverse internal and external stakeholders
• Able to apply engineering principles and statistical analysis in resolving complex issues
• Knowledge in regulatory filings and inspections
• Knowledge in broad aspect of biologics processing for example cell culture analytical methods or product quality attributes
• Familiarity in operational aspects of commercial biopharma manufacturing (e.g. process automation equipment single use)

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.

In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

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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