Sr Associate Manufacturing - Line Lead (12hr PM)

Amgen • New Albany, OH

20d

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. Manufacturing Senior Associate- Line Lead What you will do Let’s do this. Let’s change the world. In this role you will be leading all aspects of a device assembly & packaging line. Responsibility includes maintaining production in full cGMP compliance. Assist with developing technicians while overseeing production equipment to ensure production schedules are completed. Lead manufacturing operations on the production floor while helping to perform equipment setup, operation and troubleshooting. Maintain machine uptime, perform any fault clearing and clear stoppages on automated equipment. Ensure all safety and compliance procedures are followed at all times. Escalate appropriate concerns to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk. Provide training to manufacturing staff on process and equipment. Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor. Collaborate with Quality, Engineering and Manufacturing Support to resolve manufacturing events in a timely manner. Apply process, scientific, operational, and compliance knowledge with analytical and troubleshooting skills to support manufacturing operations. Champion Lean Transformation and OE initiatives, facilitate the drive towards continuous improvement in the plant. Participate in the design, development, and implementation of processes in support of the manufacturing floor. Participate in the development, implementation, and issue resolution associated with process equipment Commissioning, Qualification and Validation. Collaborate with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek will possess these qualifications.

Requirements

• High school/GED + 4 years biotech or pharmaceutical manufacturing, process development or quality experience
• Associate’s + 2 years biotech or pharmaceutical manufacturing, process development or quality experience
• Bachelor’s + 6 months biotech or pharmaceutical manufacturing, process development or quality experience work experience
• Master's

Nice To Haves

• Degree in Chemical Engineering, Industrial Engineering or Life Sciences
• Technical understanding of pharmaceutical/biotech packaging equipment and processes
• Experience with Current Good Manufacturing Practices (cGMP)
• Ability to be flexible and manage change
• Experience participating in and leading cross-functional teams
• Experience in managing multiple, competing priorities in a fast-paced environment
• Strong scientific, technical interactions with partner organizations such as PD and F&E.
• Experience in GMP Tech Support roles, GMP operations, process development or scheduling.
• Experience with Commissioning and Qualification, New Product Introduction, Cleaning Validation, and Process Performance Qualification
• Ability to organize, analyze, and interpret technical data that is impacting operations
• Background in lean manufacturing methodologies and operational excellence
• Expertise in electronic systems used in manufacturing (MES, LIMS, Maximo, CCMS, SAP, etc.)

Responsibilities

• Leading all aspects of a device assembly & packaging line.
• Maintaining production in full cGMP compliance.
• Assisting with developing technicians while overseeing production equipment to ensure production schedules are completed.
• Leading manufacturing operations on the production floor while helping to perform equipment setup, operation and troubleshooting.
• Maintaining machine uptime, perform any fault clearing and clear stoppages on automated equipment.
• Ensuring all safety and compliance procedures are followed at all times.
• Escalating appropriate concerns to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
• Providing training to manufacturing staff on process and equipment.
• Providing troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.
• Collaborating with Quality, Engineering and Manufacturing Support to resolve manufacturing events in a timely manner.
• Applying process, scientific, operational, and compliance knowledge with analytical and troubleshooting skills to support manufacturing operations.
• Championing Lean Transformation and OE initiatives, facilitate the drive towards continuous improvement in the plant.
• Participating in the design, development, and implementation of processes in support of the manufacturing floor.
• Participating in the development, implementation, and issue resolution associated with process equipment Commissioning, Qualification and Validation.
• Collaborating with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional 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, and flexible spending accounts
• 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: Mid Level
• Education Level: High school or GED