Process Development Engineer (MSAT)

Amgen Inc. (IR); Singapore; On-site; SGD 85,000 - 120,000; Full time

Job summary

Amgen Inc. (IR) in Singapore is seeking a Process Development Engineer (MSAT) to coordinate tech transfer, qualification, and performance monitoring across unit operations.

The role supports NPI and lifecycle changes by aligning process design with site procedures and capabilities. The ideal candidate will have a Master’s or Bachelor’s with relevant experience, 4+ years in biotech/pharma manufacturing, and strong problem-solving and communication skills.

Qualifications

• Master’s degree OR Bachelor’s degree and 2 years of directly related experience OR Associate’s degree and/or 6 years of directly related experience OR High school diploma / GED and 8 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
• Good cell culture and/or purification process knowledge, including single-use technologies
• Experience in troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
• Problem solving skills requiring the application of strong scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
• Demonstrated working knowledge of applicable regulatory and cGMP requirements
• Ability to learn and act on dynamic information at a rapid pace and elevate relevant issues to management when required
• Self-motivation, adaptability and a positive attitude
• Excellent communication skills, both oral and written

Responsibilities

• Coordinate assigned non-routine activities including technology transfer, process qualification, performance monitoring and troubleshooting
• Support NPI and lifecycle changes by integrating process design with site procedures
• Support make-a-batch exercises to assess facility fit and identify gaps
• Support process feasibility and control strategy development for new equipment/technology
• Lead investigations within defined scope and communicate findings to teams and leadership
• Build and maintain tech transfer efficiency tools and templated documents
• Collaborate with drug substance tech teams, NPI, QA, Supply Chain and manufacturing to align program needs with site capabilities
• Utilize strong technical and verbal communication in deviation assessment and presentations

Skills

Process engineering

cGMP

Investigations & deviation handling

Cell culture knowledge

Troubleshooting

Communication skills

Education

Bachelor’s or Master’s degree

Tools

Single-use systems

QA systems

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 (MSAT)

What you will do

• Applies engineering knowledge to coordinate assigned non-routine activities, including technology transfer, process qualification, process performance monitoring and troubleshooting of unit operations.
• Supports new product introductions (NPI) and lifecycle changes by integrating process design requirements with manufacturing site procedures and capabilities.
• Supports make-a-batch exercises to determine facility fit and identify gaps.
• Support process feasibility and control strategy development for new equipment/technology introduction.
• Contributes to investigations and, based on role level and assignment, may lead investigations within a defined scope; prepares technical and product-impact assessments and communicates findings to teams and leadership.
• Builds, maintains and improve tech transfer efficiency tools, including development of templated documents, implementation of lessons learned and more.
• Builds and sustains relationships with partners – drug substance technology teams, NPI, QA, Supply Chain, and manufacturing teams to ensure alignment between program needs and site capabilities.
• Utilize strong technical and verbal communication skills in deviation assessment and presentations.

The core responsibilities apply to Engineer I and Engineer II. The complexity of assignments, degree of independence and technical leadership increase based on role level and demonstrated

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 6 years of directly related experience OR High school diploma / GED and 8 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
• Good cell culture and/or purification process knowledge, including single-use technologies
• Experience in troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
• Problem solving skills requiring the application of strong scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
• Demonstrated working knowledge of applicable regulatory and cGMP requirements
• Ability to learn and act on dynamic information at a rapid pace and elevate relevant issues to management when required.
• Self-motivation, adaptability and a positive attitude.
• Excellent communication skills, both oral and written.

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

• competitive benefits
• development opportunities
• collaborative culture

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