Director Process Development - Purification Process Engineering

Amgen • West Greenwich, RI

1d

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. 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. Director Process Development - Purification Process Engineering What you will do Let’s do this. Let’s change the world. In this vital role you will lead the Purification Process Engineering function within Process development organization. In this role you will be responsible for technical guidance of commercial Drug Substance operations within a high mix, multiproduct manufacturing facility. This includes technical transfer and scale up of processes, deployment of novel manufacturing technologies and troubleshooting biologics manufacturing processes. The successful candidate will serve as the primary process development point of contact with key leadership partners in Manufacturing and Quality. This leader will ensure that process engineering deliverables including new process introduction; implementation of new technologies; Process Performance Qualification (PPQ) and ongoing monitoring and support of drug substance production are managed and completed. They will have an entrepreneurial approach with ambition to drive innovation and plant efficiency through exploration of process, technology and capacity improvement opportunities. The Director ensures group’s outputs are safe, compliant, and aligned with plant performance goals. Additional Responsibilities:

Requirements

• Bachelor’s degree and 10 years of Process Development, Engineering or Manufacturing experience OR Master’s degree and 8 years of Process Development, Engineering or Manufacturing experience OR Doctorate degree and 4 years of Process Development, Engineering or Manufacturing experience
• In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• Your managerial experience may run concurrently with the required technical experience referenced above

Nice To Haves

• MS degree in Chemistry, Biochemistry, Biochemical or Chemical Engineering, or in a technological field.
• 10+ years of experience in pharmaceutical/biopharmaceutical process development or process support and current in Good Manufacturing Practices (cGMP) and global regulatory expectations
• Ability in providing scientific and engineering expertise to multi-functional teams in manufacturing, quality and supply chain to advance complex projects to completion and to interface on technical problem resolution
• Ability to compile and statistically analyze data, draw appropriate conclusions and make presentations to multi-functional audience and senior management
• Detailed understanding of all stages of Process Validation lifecycle in biologics: Process Design, PPQ, Continued Process Verification (CPV)
• Understanding of quality attributes of large molecules and protein products and analytical methods for determination of these attributes
• Demonstrated skills in leadership, negotiation and managing customer expectations

Responsibilities

• Provide leadership and subject matter expertise in bioprocess purification disciplines including chromatography and filtration operations.
• Good knowledge of quality, regulatory and development requirements for large molecule manufacturing.
• Support process scale-up and technology transfer to production facilities.
• Partners closely with development teams to ensure successful transfer of knowledge to process teams during technical transfers.
• Lead a successful team committed to finding innovative ways to maximize team engagement and ensure the team reaches its full potential.
• Lead multi-functional teams to resolve complex technical problems while meeting quality, schedule, and cost objectives.
• Serve as member of Drug Substance Technology extended leadership team and utilize network thinking and advancing the process development function.
• Engage with the manufacturing and process development network to assess technology and to improve facility capacity and capability.

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: Director