Sr Engineer, PD Process Validation & Business Strategy

Amgen • Holly Springs, NC

39d

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. SR. ENGINEER, PD PROCESS VALIDATION & BUSINESS STRATEGY What you will do Let’s do this. Let’s change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgen’s FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes development, support, and execution of process validation. The role will be responsible for ensuring process validation activities are performed in a consistent and controlled manner to support manufacture of drug substances. In addition, the role will be responsible for driving PD business strategy activities and providing cross-functional tech transfer support.

Requirements

• High school diploma / GED and 10 years of biologics process development, process engineering, or process validation experience OR Associate’s degree and 8 years of biologics process development, process engineering, or process validation experience OR Bachelor’s degree and 4 years of biologics process development, process engineering, or process validation experience OR Master’s degree and 2 years of biologics process development, process engineering, or process validation experience OR Doctorate degree

Nice To Haves

• 5+ years of experience in a process validation or downstream (purification) role supporting biopharmaceutical manufacturing processes within regulated environments (i.e., cGMP)
• Strong and in-depth expertise of the operation of upstream and downstream manufacturing processes
• Validation experience with biopharmaceutical processes including PPQ, master plans, protocols, and reports
• Independently motivated with successful ability to multi-task and work in teams
• Demonstrated leadership skills and decision-making experience
• Experience in process scale-up, technology transfers, EBRs, deviation, CAPA, and change control processes.
• Excellent oral and verbal communication skills, interact effectively with diverse internal and external stakeholders

Responsibilities

• Lead the development of Process Validation/Process Performance Qualification strategy for New Products, ensuring alignment with regulatory guidelines and industry standards.
• Apply a fundamental understanding of Upstream (Cell Culture) and Downstream (Purification) bioprocessing to support process validation, technology transfer support, and plant start-up
• Lead the execution of validation projects and/or protocols and the collection of data to ensure completion of process validation activities.
• Provide cross-functional process monitoring support as needed
• Provide guidance for the generation, resolution and closure of deviations.
• Lead ANC PD business strategy activities to improve network practice, develop digital tools, and optimize the ANC PD business operations
• Ensure safety and compliance of process development activities
• Provide process validation floor process support as required
• Lead process validation support for regulatory filing, inspection, and other CMC activities

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 where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior