Localization Engineer, Sr jobs in Norwich, CT

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Senior Manager Engineering

Live

What you will do

Let’s do this! Let’s change the world! In this vital role you will lead a Downstream Process engineering team at our Rhode Island Site. The Senior Manager will lead a team focused on bioprocess purification processes, drug substance manufacturing support and technology transfer of new products into the facilities. The site operates two multiproduct facilities that manufacture a range of innovative biologic and biosimilar medicines. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility.

• Supervise a team of Process Development Engineers focused on downstream purification processes
• Lead Technology transfers of processes into the site
• Collaborate with Plant Managers, i.e., Production Managers and Senior Process Development staff to assess needs and update progress
• Perform work that involves in-depth investigation of subject area
• Conceive plans and conduct engineering research/investigation in areas of considerable scope and complexity
• Plan, prioritize and coordinate work of a staff of engineers and/or technicians
• Lead efforts with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing recommendations for large and/or highly complex system/facility or process modifications
• Designs, executes, implements, and directs engineering or process projects which significantly contribute to attaining high priority goals
• Interpretation of Processes Characterization
• Establish Testing Strategies
• Design / Development of Characterization Protocols
• Technical Reports Development
• Validations, and technical reports- support SATs executions, document generation and challenge validations strategies
• Risk assessments and QRAES knowledge, to support risk assessments activities

Win

What we expect of you

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

Basic Qualifications:

• High school diploma / GED and 12 years of engineering experience OR
• Associate’s degree and 10 years of engineering experience OR
• Bachelor’s degree and 8 years of engineering experience OR
• Master’s degree and 6 years of engineering experience OR
• Doctorate degree and 2 years of engineering experience
• AND 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 Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing
• Proven ability to lead and deliver results in a highly fluid, interactive matrixed environment
• Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
• Background working with commercial manufacture of biologics
• Strong understanding cGMP requirements
• Knowledge of regulatory filings and inspections
• Downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP) including technical support for nonconformance investigations and other commercial support activities
• Experience working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for biological molecules
• Deep understanding of operational aspects of biopharma and/or engineering industries
• Ability to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
• Skills in analysis of data generated using different analytical techniques
• Strong oral and verbal communication and presentation skills enabling strong relationships with internal and external partners
• Ability to derive insightful strategies to improve business processes
• Experience in supervision of direct reports and mentoring of matrix-team member.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.