Senior Manager – Drug Substance Technology & Engineering

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. 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.

Senior Manager – Drug Substance Technology & Engineering

What you will do

Let’s do this. Let’s change the world!

Amgen is seeking a Senior Manager to join the Drug Substance Technology & Engineering (DSTE) team at our Thousand Oaks, California site. In this onsite leadership role, you will oversee downstream purification manufacturing support unit operations supporting both clinical and commercial biologics drug substance. You will lead a team of downstream process engineers and play a key role in early phase technology transfer and the manufacturing execution, process optimization, and strategic improvement initiatives across all phases of development and the commercialization lifecycle.

This is an exciting opportunity for a strong technical and people leader who thrives in a highly collaborative, fast-paced, and innovation-driven environment. In addition to supporting commercial and pipeline programs, you will help shape cross-functional initiatives that advance technology, process performance, and business outcomes.

Location: Thousand Oaks, CA

Travel: Up to 10% domestic and international travel

KEY RESPONSIBILITIES:

• Support the development, scale-up, tech transfer and manufacturing execution of cGMP clinical and commercial downstream purification processes including, but not limited to harvest, clarification, chromatography (Protein A, AEX, CEX, etc), viral filtration, UF/DF, and sterile filtration.
• Apply engineering principles and statistical analysis in order to:
  • Identify, develop and implement downstream process improvements into the manufacturing facility.
  • Resolve technical issues observed during scale-up and/or manufacturing execution of purification processes.
• Manage escalation and on the floor support as required to achieve successful scale-up and manufacturing objectives.
• Interface with process development teams to ensure processes are robust and are designed to deliver all quality attributes and enable manufacturing success.
• Collaborate with Process Development, Quality, Manufacturing, Regulatory, Validation and Supply Chain to drive continuous improvements into our business processes.
• Lead site activities for continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management
• Ensure safety and compliance of process development activities
• Collaborate with other site-functions and network drug substance teams in delivering plant goals
• Lead cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives
• Ensure manufacturing operations are aligned with the registered process
• Provide support for regulatory filing, inspection, and other CMC activities
• Serve as member of the ATO DSTE leadership team utilizing network thinking and innovative approaches to advance the drug substance organizational capabilities

Supervising Others / Team Experience

• Create multi-year technical strategies for advancing business performance.
• Ensures that safe practices are followed.
• Provides mentoring and expertise to staff on the downstream team
• Motivates, develops, and coaches staff while promoting team collaboration
• Applies effective management practices in the direction and development of others

Leadership and Influence

• Identifies and negotiates resources and develops timelines for project activities.
• Collaborates within the department and interdepartmentally.
• Provides scientific and technical leadership
• Ensure department staff are adequately developed and trained
• Provides adequate feedback through coaching and effective performance appraisal and development planning
• Initiates and encourages scientific collaboration with groups outside the department
• Manage project resources (material, labor, time, etc.), and elevate relevant issues to project lead and line-management
• Build and maintain effective collaborations with partner organizations

Decision Making and Judgment

• Anticipates, proactively detects, and addresses problems related to departmental and interdepartmental activities.
• Inform and consults department head and senior staff appropriately

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic individual we seek is a collaborative partner with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of biologics process development or commercial-scale technical support experience OR
• Master’s degree and 6 years of biologics process development or commercial-scale technical support experience OR
• Bachelor’s degree and 8 years of biologics process development or commercial-scale technical support experience OR
• Associate’s degree and 10 years of biologics process development or commercial-scale technical support experience OR
• High school diploma / GED and 12 years of biologics process development or commercial-scale technical support experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 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:

• 8+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP)
• 5+ years directly managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources.
• Strong and in-depth expertise in purification processes
• Experience in process scale-up, technology transfer, process validation, troubleshooting, and complex investigation
• Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
• Experience developing staff to reach their full potential
• Knowledgeable in regulatory filings and inspections
• Familiarity in operational aspects of commercial biopharma manufacturing
• Familiarity in statistical analysis, analytical methods, and product quality attributes relevant to biological processing

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.

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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.