Director Process Development - Purification Process Engineering

Career Category
Operations
Job Description

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:

• 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a leader with these qualifications.

Basic Qualifications:

• 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

Preferred Qualifications:

• 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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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, work/life balance, and career development opportunities that may include:

• 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. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range
202,739.00 USD - 228,619.00 USD