Career CategoryEngineering
Job DescriptionSenior Manager - Drug Substance Technology & EngineeringWhat you will doLet'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 youWe 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 usAs 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.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
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.
Salary Range148,715.15USD -201,202.85 USD
