Process Development Engineer

Amgen Inc. (IR); Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

Amgen is seeking a Process Development Engineer to coordinate complex manufacturing activities, perform data-driven analyses, and support regulatory filings. You will work with cross-functional teams to ensure robust process development and compliant operations.

The role requires strong cell culture knowledge, cGMP experience, and proficient communication. Opportunity to contribute to impactful therapies and grow within a global biotech leader.

Qualifications

• Master's degree OR Bachelor's degree and 2 years of directly related experience OR Associate's degree and/or 4 years of directly related experience OR High school diploma / GED and 6 years of directly related experience.
• 4+ years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries.
• At least 2 years' experience with regulated environments (i.e. cGMP) required.
• In depth cell culture process knowledge, including single-use technologies and harvest technologies.
• Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production.
• Possess basic understanding of regulatory and cGMP requirements.
• Able to apply engineering principles and advanced statistical analysis in-in order to solve processing issues and evaluate opportunities for process improvements.
• Able to escalation relevant issues to project lead and line management.
• Independently motivated but also work well in team environment.
• Strong communication skills (technical writing and verbal communication/presentation).
• Problem solving skills requiring the application of strong scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.

Responsibilities

• Coordinate complex non-routine activities including tech transfer qualification.
• Lead investigations and provide concise communications to teams and leadership.
• Analyze process data using Excel, JMP, SIMCA to inform decisions.
• Author technical protocols, assessments, and product impact assessments.
• Verify data in technical reports and regulatory filings.
• Communicate clearly in technical writing and presentations.
• Support cGMP production and assist in regulatory compliance.

Skills

GMP experience

Cell culture

Troubleshooting

Technical writing

Process engineering

Education

Master's degree in related field

Bachelor's degree in related field

Associate's degree

High school diploma

Tools

Excel

JMP

SIMCA

Job description

Career Category Process Development Job Description

Join Amgen's Mission to Serve Patients

At Amgen, our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world. Amgen fights the world's toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives. If you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact.

Process Development Engineer

What you will do

Applies expertise in the successful coordination of multiple, complex, non-routine activities including tech transfer process qualification, process performance monitoring, floor support, troubleshooting of unit operations. Support/lead complicated investigations, providing concise communications to teams and leadership. Compile and analyze process data using tools such as excel, JMP, SIMCA to inform future decision-making and take predictive action. Author technical protocols, technical assessments, and product impact assessments. Verify data in technical reports, spreadsheets, and regulatory filings. Utilize strong written and verbal communication skills in technical writing and presentations. All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.

What we expect of you

Master's degree OR Bachelor's degree and 2 years of directly related experience OR Associate's degree and/or 4 years of directly related experience OR High school diploma / GED and 6 years of directly related experience. 4+ years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries. At least 2 years' experience with regulated environments (i.e. cGMP) required. In depth cell culture process knowledge, including single-use technologies and harvest technologies. Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production. Possess basic understanding of regulatory and cGMP requirements. Able to apply engineering principles and advanced statistical analysis in-in order to solve processing issues and evaluate opportunities for process improvements. Able to escalation relevant issues to project lead and line management. Independently motivated but also work well in team environment. Strong communication skills (technical writing and verbal communication/presentation). Problem solving skills requiring the application of strong scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

What you can expect of us

• Through competitive benefits, development opportunities, and a collaborative culture, we'll support your growth both professionally and personally.

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 as we 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 committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.