Senior Manager Manufacturing (API)

Senior Manager Manufacturing (API)

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 Manager Manufacturing (API) in Amgen Singapore Manufacturing.

Live

What you will do

Responsibilities

The scope includes leading a team of professionals to provide validation services for systems associated with the manufacture of active pharmaceutical ingredient (API) drug substance at the Amgen Singapore Manufacturing (ASM) facilities, supervision and development of professionals in managing, planning and implementation of changes, resolving process interruptions, driving deviation investigations, and associated continuous improvement efforts. It also involves cross functional interactions with key site functions to ensure success in validation, production and release performance. This position will establish compliant validation strategies and procedures to align with Amgen operation standards and regulatory expectation, be accountable for validation deliverables for commissioning and qualification, performance qualifications, cleaning validation and validation maintenance. Other related manufacturing execution related duties will include managing and scheduling production, maintenance, commissioning, and validation activities. It offers a broad exposure to all key aspects of GMP manufacturing as well as tactical and strategic teamwork within the extended worldwide manufacturing network.

The ideal candidate is expected to be experienced in employing a risk-based and science-based approach to the specification, design and verification of manufacturing systems and equipment. As a leader within manufacturing organization, this role will provide expectations and coaching for performance and development of Amgen Staff, represent validation and manufacturing execution for regulatory inspections.

The Sr. Manager of Manufacturing will operate under minimal supervision and will be required to leverage experience to exercise judgment in decision making and escalation with regards to operational, commissioning and validation issues.   

Responsibilities:

General:

• Establish compliant validation strategies and procedures to align with Amgen operating standards and regulatory expectations
• Accountable for completing milestones as they relate to validation deliverables for commissioning and qualification, performance qualifications, cleaning validation, and validation maintenance
• Ensure that all staff working on validation are adequately trained and skilled to perform their duties
• Provide technical support to troubleshoot, identify and resolve equipment and system issues as required
• Own and lead investigations associated with validation or process deviations and non-conformances

• Manage change controls, corrective actions and preventative actions associated with validation or process equipment
• Deliver results in accordance with cGMP and safety requirements. Be part of ASM 2 leadership to advocate and drive safety and quality culture of the department and lead continued improvements within the areas of scope.

Leading strategy development and execution:

• Champions cultural transformation and institutionalizes changes in process, practices, business models, governance, etc.
• Anticipates risk and builds contingencies to help mitigate impact on operations
• Deliver strong business results
• Develop and monitor process performance metrics to identify continual improvement opportunities

Building a strong organizational alignment:

• Effectively collaborate with key customers and support groups (Manufacturing, Quality, Process Development, & network partners)
• Lead and/or support Amgen global network initiatives
• Develop and implement departmental strategy and plans that are aligned with the broader organizational strategy

Attracting, developing and retaining diverse talent:

• Build, develop and retain a diverse and high performing team, build technical and leadership capabilities within the organization to meet current and future business needs

Delivering financial commitments:

• Deliver against organizational financial commitments
• Represent validation and manufacturing execution for filings, audits and regulatory inspections

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

Basic Qualifications

• Doctorate degree in Science or Engineering and 2 years of directly related experience OR
• Master’s degree in Science or Engineering and 6 years of directly related years’ experience OR
• Bachelor’s degree in Science or Engineering and/or 8 years of directly related experience AND
• 2 years of managerial experience directly managing people and / or leadership experience leading teams, projects, programs or directing the allocation of resource
• 8+ years’ experience in support of commercial drug operations (manufacturing, quality, process development, clinical mfg, engineering)
• 5+ years managing a team (leading and managing operations)
• 2+ years project management (identify goals, manage resources, assign tasks, present progress/milestones, develop cost/benefit analysis and negotiate resolution) 
• 2+ years operations and/or technical experience in the pharmaceutical industry; managing process improvement through Operational Excellence, depth in one operations area (information systems, manufacturing, quality, process development, engineering, etc.) 
• Ability to understand, apply and evaluate advanced chemistry, biology and physical principles
• Experience in reviewing and approving validation protocols and reports in support of facility/equipment commissioning, qualification, and change management.
• Experience in technical execution of validation tasks associated with cleaning validation and commissioning.
• Experience in supporting regulatory agency interactions such as regulatory submissions, response to submission questions, pre-approval/biennial inspections, and observational response plans.  Generate and implement validation strategies that maintain a robust regulatory compliance position in a dynamic, business competitive environment.
• Ability to adhere to regulatory requirements, written procedures and safety guidelines
• Ability to evaluate documentation/data according to company and regulatory guidelines
• Ability to interact with inspectors (internal and external)
• Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge
• Ability to demonstrate project management skills
• Demonstrated excellent technical written and oral communication skills, including executive level communications
• Experience in facility start-up, commissioning and qualification and facility licensure
• Proficient presentation and facilitation skills
• Detail oriented as well as flexible and adaptable to changing priorities and requirements
• Ability to independently collaborate with outside resources
• Demonstrated ability to coach, mentor and train staff within core technical areas. Able to drive employee engagement activities to differentiate site / company as a great place to work. 
• Ability and willingness to work any shift in support of operations
• Strong leadership skills, decision-making, problem-solving abilities.

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.

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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.