Senior Manager Manufacturing (API) Job at Amgen (Tuas)

Job Description

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.

Job Responsibility

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

Requirements

Doctorate degree in Science or Engineering and 2 years of directly related experience
Master’s degree in Science or Engineering and 6 years of directly related years’ experience
Bachelor’s degree in Science or Engineering and/or 8 years of directly related experience
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.

What we offer

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

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