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Sr Mgr Engineering

Amgen21h ago
United StatesHybridFull-timeManager Level2+ yrs exp
H-1B sponsor

Top focus

Vp EngineeringEngineering ManagerDirector Engineering

Career Category 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.

SR MGR ENGINEERING What you will do Let’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 you We 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
  • 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
  • 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
  • product quality attributes related 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
  • 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
  • flexible spending accounts A discretionary annual bonus program
  • 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 In any materials you submit, you may redact or remove age-identifying information such as age, date of birth
  • 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.
  • 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
  • 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
  • to receive other benefits and privileges of employment.
  • Please contact us to request accommodation. .
  • Salary Range 148,715.15USD -201,202.85 USD

Required skills

biologics process developmentcommercial-scale technical supportcell culture processesprocess scale-uptechnology transferprocess validationtroubleshootingcomplex investigationregulatory filingsstatistical analysisanalytical methodsproduct quality attributes
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