Senior Manager Process Development (MSAT)

amgen; Singapore; On-site; SGD 180,000 - 240,000; Full time

Job summary

Amgen is seeking a Senior Manager Process Development (MSAT) to lead biologics tech transfer and ongoing cGMP production support for commercial processes. The role encompasses scale-up, validation, troubleshooting, and cross-functional collaboration to meet quality, schedule, and cost objectives.

The successful candidate will manage a Process Development team, drive technology evaluations, and support regulatory filings and inspections, contributing to drug substance leadership and overall site

Qualifications

• PhD or equivalent with biologics PD or scale-up experience.
• 8+ years in biotech processes in regulated (cGMP) environments with 2+ years of management.
• Strong cell culture or purification process expertise.
• Experience with tech transfer, validation, troubleshooting and investigations.
• Excellent communication with diverse stakeholders; regulatory familiarity.

Responsibilities

• Lead biologics technology transfer, process validation and new tech evaluation/implementation.
• Lead site activities for process optimization, complex investigations, and lifecycle management.
• Manage a team in Process Development and key projects across functions.
• Collaborate with cross-functional and network teams to resolve complex challenges.
• Deliver site goals on schedule and within cost, maintaining safety and compliance.
• Support regulatory filings, audits, inspections, and other CMC activities.
• Serve on the DST extended leadership team to advance capabilities.

Skills

Biologics PD

cGMP expertise

Technology transfer

Team leadership

Process validation

Regulatory filings

Statistical methods

Education

Doctorate in Biotech

Master's in Biotech

Bachelor's in Biotech

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 guides everything we do. By combining science, innovation, and collaboration, we work to address some of the world's toughest diseases and improve the lives of millions of people worldwide.

Amgen harnesses the best of biology and technology to help make people's lives easier, fuller, and longer. Every role contributes to that mission, creating meaningful opportunities to lead, innovate, and make a lasting impact.

If you're motivated by complex challenges, strategic thinking, and the opportunity to influence outcomes, we encourage you to explore a career with Amgen.

Senior Manager Process Development (MSAT)

What you will do

The Senior Manager will apply process engineering subject matter expertise to support technology transfer and ongoing cGMP production of commercial protein biologics processes. Scope of work could include:

• Lead projects focused on biologics technology transfer, process validation, and new technology evaluation/implementation.

• Lead site activities for process optimization, complex investigation, and product life cycle management.

• Manage a team of direct reports in Process Development group, manage key projects or business processes across functions.

• Collaborate with cross-functional teams and network drug substance teams to resolve complex challenges by applying advanced technical principles and concepts for troubleshooting.

• Manage key projects to deliver site goals while meeting quality, schedule, and cost objectives.

• Ensure safety and compliance of process development and/ or manufacturing activities.

• Provide support for regulatory filings, audits and inspections, and other CMC activities.

• Serve as member of the Drug Substance Technology (DST) extended leadership team utilizing network thinking and innovative approaches to advance the drug substance organizational capabilities.

Win

What we expect of you

Qualifications

• Doctorate degree and 2 years of biologics process development or commercial-scale technical support experience OR

• Master’s degree and 6 years of biologics process development or commercial-scale technical support experience OR

• Bachelor’s degree and 8 years of biologics process development or commercial-scale technical support experience

• 8+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP) and 2+ years of management experience.

• Strong and in-depth expertise in cell culture and/or purification processes.

• Experience in process scale-up, technology transfer, process validation, troubleshooting, and complex investigation.

• Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders.

• Knowledgeable in regulatory filings and inspections.

• Familiarity in operational aspects of commercial biopharma manufacturing.

• Familiarity in statistical analysis, analytical methods, and product quality attributes related to biological processing.

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

At Amgen, you'll work alongside talented colleagues in an environment that values innovation, collaboration, and growth. We are committed to helping you develop your career while contributing to work that matters for patients.

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 with 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.