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Sr Manager Engineering

Company: Amgen
Location: West Greenwich
Posted on: June 9, 2024

Job Description:


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


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


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.


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.


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.

Keywords: Amgen, Warwick , Sr Manager Engineering, Engineering , West Greenwich, Rhode Island

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