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Senior Engineer, Process Development (Downstream)
Biospace Holly Springs, NC
$89k-106k (estimate)
Full Time | Scientific Services 2 Months Ago
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Biospace is Hiring a Senior Engineer, Process Development (Downstream) Near Holly Springs, NC

HOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Senior Engineer, Process Development (Downstream)Live!What You Will DoLets do this. Lets change the world. In this vital role you will advance Amgen latest bioprocessing platform and technology, delivering high quality of medicine to patients around the world.
The Sr. Engineer will be part of the Process Development-Drug Substance Technology at Amgens FleX Batch facility, focusing on technology transfer, process support, and optimization. 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.
  • Support technology transfer, process validation, and plant start-up
  • Provide technical leadership in Downstream (Purification) Bioprocessing for process monitoring, optimization, yield improvement, complex investigation, and product life cycle management
  • Partner with multi-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives
  • Provide on-the-floor process support as required
  • Ensure safety and compliance of process development activities
  • Collaborate with other site-functions and network drug substance teams in delivering plant goals
  • Support regulatory filing, inspection, and other CMC activities
Win!What We Expect Of YouWe are all different, yet we all use our unique contributions to serve patients. The inspiring professional we seek is a strong team-player with these qualifications.
Basic Qualifications
  • High school diploma / GED and 10 years of biologics process development or commercial-scale technical support experience OR
  • Associates degree and 8 years of biologics process development or commercial-scale technical support experience OR
  • Bachelors degree & 4 years of biologics process development or commercial-scale technical support experience OR
  • Masters degree & 2 years of biologics process development or commercial-scale technical support experience OR
  • Doctorate degree
Preferred Qualifications
  • Bachelors degree in Engineering or Science field
  • 5 years proven experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP)
  • In-depth expertise in biologics process purification processes
  • Experience in process scale-up, technology transfer, process validation, process optimization, troubleshooting, and complex investigation
  • Strong oral and verbal communication skills, interact optimally with diverse internal and external collaborators
  • Able to apply engineering principles and statistical analysis in resolving complex issues
  • Knowledge in regulatory filings and inspections
  • Knowledge in broad aspect of biologics processing, for example cell culture, analytical methods, or product quality attributes
  • Familiarity in operational aspects of commercial biopharma manufacturing (e.g. process automation, equipment, single use)
Thrive!What You Can Expect Of UsAs 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.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now for a career that defies imaginationObjects in your future are closer than they appear. Join us.
careers.amgen.com

Job Summary

JOB TYPE

Full Time

INDUSTRY

Scientific Services

SALARY

$89k-106k (estimate)

POST DATE

05/30/2024

EXPIRATION DATE

07/16/2024

WEBSITE

biospace.com

HEADQUARTERS

CERRITOS, CA

SIZE

50 - 100

FOUNDED

1985

CEO

KI CHUL CHA

REVENUE

$10M - $50M

INDUSTRY

Scientific Services

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About Biospace

BioSpace serves as the leading online source for biotechnology jobs, breaking industry news and expert analysis. BioSpace has accelerated recruitment, communication and discovery among business and scientific leaders within the life sciences for more than 30 years.

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