Mfg Tecnologies Sr Mgr

Amgen • Holly Springs, NC

4d • Hybrid

About The Position

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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
• Proficient communication skills in English.

Nice To Haves

• 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.
• 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.

Responsibilities

• 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.
• 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 of provide input and review of related global training materials.
• Strategize with Technology team on application roadmap and accommodating new offered functionality.
• Own system related controlled documents such as data integrity assessment report, operational SOPs, and training content.
• Lead and approve validation documents and records such as validation plan, OQ protocol, configuration specifications, requirements specs, validation summary (backup) report, test scripts, test sets, and test runs mostly for MES but also some for ERP.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree