Sr Engineer I - Holly Springs, NC

Military Spouse Corporate Career Network • Holly Springs, NC

19h • Onsite

About The Position

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 Amgen’s 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.

Requirements

• Master’s degree in in Engineering or Science discipline
• 5+ years of 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 effectively with diverse internal and external stakeholders
• 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)
• High school diploma / GED and 10 years of biologics process development or commercial-scale technical support experience OR Associate’s degree and 8 years of biologics process development or commercial-scale technical support experience OR Bachelor’s degree and 4 years of biologics process development or commercial-scale technical support experience OR Master’s degree and 2 years of biologics process development or commercial-scale technical support experience OR Doctorate degree

Nice To Haves

• Preferred experience in Oncology
• Three or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries.
• Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation.
• Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties.
• Local Market knowledge.
• A Bachelor's degree in Life Sciences or Business Administration.
• Adaptability with our Core Competencies: Planning and Organizing; Leveraging Business, Industry, and Technical Knowledge; Communicating with Impact; Driving for Results; and Cultivating Internal and External Relationships.

Responsibilities

• 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 cross-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

Benefits

• 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, 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
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior