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Sr Manager Biopharmaceutical Engineering

Employer
Amgen
Location
West Greenwich, Rhode Island
Start date
Jun 12, 2024

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Senior Manager Bioprocess Engineering

Live

What you will do

Lets do this! Lets change the world! In this vital role you will lead a Downstream BioProcess 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 including large scale protein purification using column chromatography and tangential flow filtration.
  • Lead Technology Transfers of bioprocesses of large-scale mammalian cell culture producing monoclonal antibodies and their purification into drug substance at the site
  • Conceive plans and conduct engineering research/investigation in areas of considerable scope and complexity for process improvements.
  • Plan, prioritize and coordinate work of a staff of bioprocess engineers.
  • Interpretation of Processes Characterization for unit operations (chromatography, filtration, tangential flow filtration, filtrations. mixing)
  • Lead efforts for process improvements with manufacturing, process development, facilities, quality assurance and validation departments in developing recommendations for large and/or highly complex system/facility or process modifications.
  • Collaborate with Plant Managers, Production Managers and Senior Process Development staff to assess needs and update project progress.
  • Validations, and technical reports with document generation and validations strategies

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
  • Associates degree and 10 years of engineering experience OR
  • Bachelors degree and 8 years of engineering experience OR
  • Masters 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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
US

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