Senior Manufacturing Associate

Senior Manufacturing Associate

Amgen Singapore Manufacturing

HOW MIGHT YOU DEFY IMAGINATION

Amgen is one of the worlds 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 Senior Manufacturing Associate in Amgen Singapore Manufacturing.

Live

What you will do

This position supports contamination control inspection readiness and process support deliverables for ASM Manufacturing. Under general direction the role partners with Manufacturing Quality Compliance Facility & Engineering EHSS and other stakeholders to maintain GMP readiness identify potential contamination risks support investigations and drive assigned improvement actions.

Responsibilities

Contamination Control

• Support execution of the ASM1 Manufacturing contamination control program under direction of the Contamination Control Lead.
• Own deviations (minor/major) perform data gathering/investigation impact assessment and documentation support for contamination-related events deviations and CAPA.
• Lead low-to-moderate complexity investigation workstreams and support complex investigations led by the Contamination Control Lead.
• Prepare and maintain assigned dashboards metrics and follow-up trackers for site and network discussions.
• Support maintenance of cleanroom procedures gowning practices contamination response procedures and environmental monitoring program deliverables.
• Coordinate with the EM Sampling team area owners and cross-functional stakeholders to ensure sampling readiness timely follow-up and closure of observations.
• Drive assigned actions and small-to-moderate improvement initiatives to improve contamination control effectiveness.

Inspection Readiness

• Support CAPA applicability assessment and implementation of identified CAPA (if required).
• Prepare verify and organize inspection support materials storyboards pressure test packages and evidence binders as assigned.
• Support triage room activities during regulatory inspections including request coordination document retrieval and response preparation under lead direction.
• Partner with Compliance and cross-functional teams to ensure prompt follow-up on inspection requests observations near misses and lessons learnt.
• Serve as SME to present deviations CAPA change control records when required during inspections.

Process Support

• Lead/Support manufacturing deviation investigations impact assessments batch record/documentation reviews and manufacturing technical assessments.
• Initiate assess and implement low-to-moderate complexity change controls with guidance; support complex change controls
• Identify digitalization/improvement opportunities to drive improvement in deviation CAPA and change control work processes

Win

What we expect of you

Basic Qualifications

• Masters Degree OR
• Bachelors Degree and 2 years of directly related experience OR
• Associates Degree and 6 years of directly related experience OR
• High School Diploma / GED and 8 years of directly related experience
• Technical knowledge of biopharmaceutical upstream downstream processing cleanroom operations and single use systems.
• Experience in writing and owning major/minor deviations CAPA and change controls related to contamination control and/or manufacturing.
• Experience leading/supporting investigations CAPA audit readiness activities and risk assessments
• Basic understanding of GMP and regulatory expectations related to manufacturing documentation change control deviations/investigations and CAPA.
• Working knowledge of contamination control expectations for biologics manufacturing including cleanroom behaviour gowning EM and contamination response.
• Ability to analyse routine EM/process data identify trends communicate risks and escalate appropriately
• Strong technical writing communication skills and ability to work effectively with cross-functional stakeholders and network partners.
• Ability to work with limited supervision prioritize assigned deliverables and follow through on commitments.
• Practical experience and interest in exploring the use of digital technologies (Power BI Customized ChatGPT etc) to improve workflows and drive continuous improvement

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.

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

Apply now

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.

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.