Manager Quality Control (Micro and Sample Management)

Amgen Singapore Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Manager Quality Control (Micro and Sample Management) in Amgen Singapore Manufacturing.

Live

What you will do

In this vital role, you will be responsible for QC Microbiology Shift teams. Responsibilities include leading and supervision of staff, maintenance of the weekly lab schedule and prioritization of daily work tasks. Providing Quality oversight to ensure that processes are followed in accordance to current Good Manufacturing Practices (cGMP). The Manager will ensure that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations. Perform review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to nonconformance records and CAPAs.

Under minimal supervision, the Manager Quality Control will be responsible for overseeing day to day activities in microbiology (including but not limited to routine environmental & utilities monitoring; raw material and product testing such as bioburden, microbial limits test, endotoxin, qPCR, microbial ID; media, reagent and culture qualification such as growth promotion; etc.), sample management and stability (including but not limited to sample logging, receipt and processing, sample aliquoting, movement and storage of samples, stability initiations and time point pulls, etc.). The Manager Quality Control will collaborate with the global Amgen QC network and provide on-site support and collaboration for both biologics and small molecule manufacturing.

Additional Responsibilities:

• Responsible for presenting the QC Microbiology lab area during audits and inspections
• Functional Area Owner for microbiology testing, stability processing and shipment deviations
• Oversight of Microbiology laboratory investigations
• Lead laboratory troubleshooting and problem-solving exercises
• Manage Contract Test Lab sample lifecycle (purchase orders to results)
• Oversight of LIMS Lot Authorization and on-time lot disposition deliverables
• Responsible for ensuring compliance with safety guidelines, cGMPs and other applicable regulatory requirements.
• Support staff training, career development and performance management.
• Support site and global initiatives
• Support the implementation of new equipment and technologies
• Supports Continual Improvement and LEAN initiatives, programs and projects
• Ensures that changes that could potentially impact product quality are assessed according to procedures
• Ensures that deviations from established procedures are investigated and documented per procedures
• Ensures that records are complete, accurate, and documented according to written procedures and cGMP requirements
• Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
• Alerts senior management of quality, compliance, supply and safety risks
• Represents the quality unit during audits and inspections
• Supports internal/external audits and inspections as part of the audit/inspection management team

Win

What we expect of you

Basic Qualifications

• Doctorate degree OR
• Master’s degree and 2 years of Quality or Operations related experience OR
• Bachelor’s degree and 4 years of Quality or Operations related experience OR
• Diploma and 8 years of directly related experience
• Strong knowledge and understanding of microbiology testing methodology and strategy for contamination control
• Knowledge and experience with general GMP laboratory operations, data integrity requirements and associated laboratory equipment
• Experience with computerized laboratory information management systems, electronic laboratory notebooks and other QC analytical equipment
• Ability to lead diverse teams
• Good communication skills (technical writing and verbal communication/presentation)
• Ability to work in cross-functional and multisite teams
• Interact effectively with variety of communication and working styles
• Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

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.

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a 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 an accommodation.