Mfg Tecnologies Sr Mgr

About the role

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. In this vital role, you will manage a defined set of Manufacturing Execution Systems (MES) objects, such as GMBRs (electronic batch records) and equipment management objects (ESPs, state diagrams), that are utilized across all applicable manufacturing sites.

Responsibilities

• Collaborate, communicate, and be accountable for leading forums with multi-functional areas and make the appropriate decisions for the best interest of Amgen.
• May include ownership of global MES SOPs in addition to providing input and review of related global training materials.
• Strategize with the Technology team on application roadmap and accommodating new offered functionality.
• Own system-related controlled documents such as data integrity assessment reports, operational SOPs, and training content.
• Lead and approve validation documents and records such as validation plans, OQ protocols, configuration specifications, requirements specs, validation summary (backup) reports, test scripts, test sets, and test runs—mostly for MES but also some for ERP.

Requirements

• Doctorate degree and 2 years of Manufacturing support experience
• OR Master’s degree and 4 years of Manufacturing support experience
• OR Bachelor’s degree and 6 years of Manufacturing support experience
• OR Associate’s degree and 10 years of Manufacturing support experience
• OR High School diploma / GED and 12 years of Manufacturing support experience

Qualifications

• Academic background in Life Science and/or Engineering.
• Leadership experience managing contractors and indirect reports.
• Background in Drug Substance, Finish Drug Product (FDP), and/or Drug Product.
• MES technology knowledge with experience modifying batch records.
• Proficient communication skills in English.
• Experience with MBR design in Koerber’s PAS|X.
• MES system experience in biological manufacturing floor operations.
• Regulated environment work experience with cross-functional collaboration, working in teams.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
• Group medical, dental, and vision coverage, life and disability insurance.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements, where possible.

Pay

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals.