Senior Manufacturing Associate I (Process Owner) at Amigen

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

10 Feb, 26

Salary

0.0

Posted On

12 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Technical Support, Engineering, Manufacturing Support, Mammalian Cell Culture, Protein Purification, Single Use Systems, Technology Transfer, Process Design, Commissioning, Validation, Change Control, Analytical Skills, Interpersonal Skills, Collaboration, Project Management, Regulatory Compliance

Industry

Biotechnology Research

Description

Career Category Manufacturing Job Description Senior Manufacturing Associate I 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 Senior Manufacturing Associate I in Amgen Singapore Manufacturing. Live What you will do Applying engineering principles to recommend, design, and implement new equipment or system modifications Working closely with multiple disciplines, including manufacturing, engineering, utility operations, maintenance, quality assurance, and validation to implement operational improvements Providing technical support to commercial manufacturing as needed Support troubleshooting and resolve equipment, automation, or process issues of simple/moderate complexity in the field Ensuring optimal and cost-effective performance and reliability for process systems Developing, organizing, analyzing, and presenting results for operational issues and engineering projects of moderate scope and complexity Communicating proactively with supervisor and support staff, highlighting issues and proposing solutions Technical expert who helps introduce advanced technologies and approaches generally described as “Next Generation Manufacturing” – into the plant. Lead and drive root cause analysis investigations arising from major deviations including the development and implementation of corrective and preventive actions Initiate and manage change controls of moderate to complex scope including but not limited to continuous improvement and productivity initiatives Manage the implementation, development and changes associated with process equipment Commissioning, Qualification and validation Prepare, coordinate, and present complex information at cross-functional team meetings, teleconferences, and management reviews Provide on-call support Win What we expect of you Qualifications Master’s degree OR Bachelor’s degree and 2 years of directly related experience OR Associate’s degree and/or 4 years of directly related experience OR High school diploma / GED and 6 years of directly related experience" 5+ years’ experience in GMP technical support/engineering or manufacturing support environment with at least 3 years’ experience in the Pharmaceutical or Biotechnology industries. Extensive knowledge of Mammalian Cell Culture, Protein Purification, Single Use Systems Experience with Technology Transfer, Process Design, and Commissioning Experience with validation and change control methodology Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) including detailed understanding of cGMPs. Position requires excellent written and verbal communication skills and the ability to work with minimum direction. Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment. Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information Demonstrated ability to lead and influence cross-functional teams and embrace a team-based culture Familiarity with designing and operating equipment used in biopharmaceutical manufacturing Experience that includes the management of complex projects, tasks or processes, or management of functional or cross-functional teams Ability to communicate and collaborate with technical and management staff within manufacturing, process development, quality engineering, quality control, and quality assurance. Experience that has provided the candidate with a detailed understanding of the regulatory and compliance environment, the GMP processes and the business processes associated with typical biotechnology / pharmaceutical manufacturing operations 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. 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. . 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

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Responsibilities

The Senior Manufacturing Associate I will apply engineering principles to recommend, design, and implement new equipment or system modifications while providing technical support to commercial manufacturing. They will also lead root cause analysis investigations and manage change controls related to continuous improvement initiatives.