Total 3 job vacancies by Amgen Singapore Manufacturing Pte. Ltd.

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 an Senior Manager (Process Development) in Singapore.

Senior Manager (Process Development)

What you will do

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

• Lead site PD activities for continuous improvement, productivity improvement, and product life cycle management.

• Lead and manage PD safety and compliance initiatives including inspection readiness.

• Manage and oversee PD related projects, ensuring they are completed on time, within scope, and budget. Analyze project outcomes to identify areas for improvement and drive continuous optimization.

• Represent PD on key projects or business processes.Stay abreast of industry trends and leverage expertise to ensure the success of the Amgen Singapore Site, focusing on reliability, efficiency, agility, and differentiation.

• Collaborate with cross-functional teams and network drug substance teams for process alignment by applying advanced technical principles and concepts.

• Site PD champion for digital literacy and new digital tools deployment for process monitoring, tech transfer, and facility modeling. Apply best practices to leverage data for more proactive and predictive approaches.

• Support regulatory filings, audits and inspections, and other CMC activities.

Win

What we expect of you

Basic 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

Preferred Qualifications

· 6+ years in a technical role supporting manufacturing processes or 8+ years as a project manager for cross-functional teams within regulated environments (i.e., cGMP)

· Strong oral and verbal communication skills, interact effectively with diverse internal and external (suppliers) stakeholders.

· Knowledgeable in regulatory filings authoring and inspections. Experienced in biopharma product end to end lifecycle management (e.g product team lead).

· Familiarity in MoF single use facility operational aspects of commercial biopharma manufacturing and proficient in big data analysis.

· Working experience with capital / engineering project from early stage to project turnover.

· Stakeholder Communication: Maintain clear and effective communication with all project stakeholders in multicultural working environment, including providing regular updates and managing expectations.

· Agility and Learning: Promote a culture of agility and learning within project teams, encouraging innovation and adaptability in a dynamic business environment.

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.

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.

Sr Mfg Systems Engineer

Amgen Singapore Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independentbiotechnology 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 Sr Mfg Systems Engineer in Amgen Singapore Manufacturing.

Sr Mfg Systems Engineer

Live

What you will do

As a Sr Mfg Systems Engineer, you will be responsible to provide engineering domain expertise support to the manufacturing plants, utilities and site facilities operation to ensure consistent product supply and deliver production target. You will be entrusted with the responsibility to ensure maximum plant capabilities through continuous improvement initiatives and projects working with group of multi-functional experts. You are the hands-on leader actively involved in project delivery and provide the overall direction for the technical design, utilization and expansion of the automation control so that equipment and facilities will be optimized in accordance to Good Manufacturing Practice, Good Engineering Practice and in compliance with regulatory requirements as well as EHSS requirements.

Responsibilities

· Lead and run the development of new product launch, new capabilities and optimization operational project initiatives to facilitate technical transfer of new program into manufacturing and provide the automation solution

· Provides technical support for new equipment/process start-ups and operation

· Responsible for the execution of all design, build and run activities

· Ensure robust testing of new configuration features based on structure risk assessments

· Coordinate validation activities in collaboration with Manufacturing, IT, and QA

· Partner with multi-functional teams to ensure end-to-end process design and system integration to improve operational efficiency

· Find opportunities to improve existing control processes and equipment by demonstrating and setting industry best practices

· Lead complex operational plant solving efforts and investigation of production process, equipment, systems and code/configuration

· Perform Root Cause Analysis, develop corrective and preventive actions, effective countermeasures and implement the solutions to prevent recurrence

· Work closely with stakeholder to ensure production supply

· Collaborate with multi-functional team to resolve incidents, events or deviations

· Provide operational support to the GMP processes including some off-hours on-call support

· Support plant improvement initiatives and projects

· Active involvement in proposing the direction and implementation of the automation control

· Make changes to manufacturing process control under strict GMP change control management process to optimize processes and maintain compliance

· Update or develop standard operating procedures, work instructions, functional / design specifications associated with automation control and system

· Support engineering process performance management, audit and inspection

· Provide technical guidance to team of engineers

· Provide training to plant personnel on automation control process

· Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity

· Promote Safety, Quality and Compliance culture and continuous improvement mentality that lead to plant safety, quality and compliance to regulatory requirement

· Support Service Owner and System Owner roles for DeltaV, PLCs, and other site Automation systems at ASM

Win

What we expect of you

Qualifications

· Doctorate Degree in Engineering, Information Systems, Computer Science, or Life Sciences OR

· Master Degree in Engineering, Information Systems, Computer Science, or Life Sciences and 2 years of directly related experience OR

· Bachelor’s Degree in Engineering, Information Systems, Computer Science, or Life Sciences and 4 years of directly related experience OR

· High School Diploma in Engineering, Information Systems, Computer Science, or Life Sciences / GED and 8 years of directly related experience

· Preferred 6+ years’ experience in manufacturing automation, particularly in biotechnology or pharmaceutical industries

· Hands on experience with automation systems and be particularly proficient in Emerson and Siemens technology

· Demonstrated ability to lead and run projects and work effectively as a teammate

· Solid understanding of pharmaceutical/biotech processes

· Solid understanding of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards

· Solid understanding of EHSS requirements

· Team player with excellent interpersonal and communication skills and ability to interact with a diverse group of people at multiple levels within the organization

· Able to work independently and get results on multiple assignments in fast-paced environment

· Excellent problem-solving skills and customer focused

· Proactive and willing to take on challenges

· Experience in supporting information interfaces, data conversion and network infrastructure

· Experience with installation, administration and solving computer data networks and servers is preferred

· Define, measure and improve system performance based on tangible metrics

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.

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.

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 an Snr/Occupational Health Nurse in Amgen Singapore Manufacturing.

Live

What you will do

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

As the Snr/Occupational Health Nurse you will be responsible to lead the Occupational Health (OH) Program for Amgen Singapore, which includes key aspects of both care management of employees and strategic OH planning.

As an integral part of EHSS team and being part of Amgen OH network, this role reports to EHSS Director and dotted line to Global OH Lead/designate. As Amgen Singapore adopts a Total Workplace Safety and Health approach, this role is essential in building a holistic and integrated approach to manage the interactions between work, safety and health to promote the well-being of both employees and Amgen Singapore.

Other scopes include injury/illness care, medical surveillance exams & testing, wellness screening, fitness center oversight, compliance tracking & record keeping, travel health consultation, emergency response and disaster preparedness.

Responsibilities:

• Manage OH programs for Amgen to optimize health care and return to work, assess health risks and ensure health-based programs are developed, documented, and implemented in accordance with both Singapore regulatory and Amgen’s requirements.
• Lead the operational activities for OH facilities – first aid room, nursing room and provide resources and physical health clearance to fitness facilities’ accesses.
• Render emergency medical care for employees, for example first aid treatment. Lead the First Aid Program for the site and ensure the readiness of first aiders in emergency response situations.
• Follow up with designated workplace doctor (DWD) on occupational related incidents and update the Amgen Incident Database. Instrumental in ensuring that work related incidents are properly managed, timely communicated and followed-up.
• Set up, manage and/or monitor medical/health contracts and service level agreements with external DWD, to ensure it is in line with company procurement standards, and continuously improve case management protocols.
• Manage site OH medical records in accordance to local regulatory requirements and Amgen record retention policy, including first aid records, equipment maintenance/ calibration records etc.
• Monitor and manage employees on routine medical surveillance program. Lead the site in pre-employment and regular medical assessment activities.
• Render OH SME support and advice in site’s Wellness program for Amgen Singapore in accordance to Amgen Corporate and Singapore HPB program. Partner with site Wellbeing Lead for a holistic Total Workplace Safety and Health solution in Amgen Singapore. Some examples include leading the general/targeted/interventional health screening or management, as well as healthy food programs.
• Oversee the site’s Return-to-Work program, as well as work accommodation plans.
• Partner closely with key stakeholders such as Human Resources department in the management of related OH programs for employees.
• Support employees with traveling health requirements (e.g. travel kits, vaccinations etc.) as part of Travel Health Program management.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Win

What we expect of you

Required Qualifications

• Bachelor’s degree in nursing or relevant qualification with practicing certificate and 4 years of directly related experience OR
• Diploma in nursing or relevant qualification with practicing certificate and 8 years of directly related experience
• Nursing Administration/ Management/ Advance Leadership Diploma is highly desirable

Preferred Qualifications

• Relevant industrial experience specifically in manufacturing industry, with minimum 3-5 years’ experience in Occupational Health.
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff

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.

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.