Career CategoryEngineering
Job DescriptionSR MGR ENGINEERINGWhat you will doLet's do this. Let's change the world. In this vital role you will provide scientific and technical leadership within the Process Development upstream group at Amgen's Flex Batch Biologics Manufacturing Facility. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network.
- Lead a technical team focused on biologics technology transfer, process validation, and plant start-up support
- Lead site activities for 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
- Assure manufacturing operations are aligned with the registered process
- Provide support for regulatory filing, inspection, and other CMC activities
- Serve as member of the Drug Substance Technology (DST) extended leadership team utilizing network thinking and innovative approaches to advance the drug substance organizational capabilities
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a leader with these qualifications.
Basic Qualifications:- High school diploma / GED and 12 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
- Bachelor's degree and 8 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
- Doctorate degree and 2 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 of management experience
- Strong and in-depth expertise in cell culture 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 related 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 deadlineAmgen 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.
SponsorshipSponsorship for this role is not guaranteed.
Salary Range148,715.15USD -201,202.85 USD
