Senior Manager Process Development (MSAT)

Amgen Inc. (IR); Singapore; On-site; SGD 180,000 - 260,000; Full time

Job summary

Amgen is seeking a Senior Manager, Process Development (MSAT) in Singapore to lead biologics tech transfer, process validation, and new technology evaluation. You will guide site activities for process optimization, investigations, and lifecycle management while collaborating with cross-functional teams to meet safety, quality, and cost objectives.

With 8+ years in biotech processes and 2+ years in management, you will drive regulatory readiness, support filings, and contribute to DST leadership

Qualifications

• PhD with 2+ years biologics process development or MS with 6+ years or BS with 8+ years in biologics/process development.
• 8+ years in a technical role supporting biotechnology processes in regulated environments (cGMP) with 2+ years of management.
• Deep expertise in cell culture and/or purification processes.
• Experience in process scale-up, technology transfer, process validation, troubleshooting and complex investigations.
• Strong oral and written communication with diverse stakeholders.
• Knowledge of regulatory filings and inspections.
• Familiarity with commercial biopharma manufacturing operations.
• Familiarity with statistical analysis and analytical methods related to biological processing.

Responsibilities

• 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.

Skills

Biologics process development

Cell culture

Purification processes

Process scale-up

Technology transfer

Process validation

Troubleshooting

Complex investigation

Communication skills

Regulatory filings

Statistical analysis

Analytical methods

Product quality attributes

Education

Doctorate degree in Biologics

Master’s degree in Biologics

Bachelor’s degree in Biologics

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

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.

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