Engineer

Amgen • Cambridge, MA

10d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Engineer What you will do Let’s do this! Let’s change the world! In this vital role you will be responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Amgen manufacturing network and/or Contract Manufacturing Organizations. You will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing process in a cGMP environment. Provide solutions to a variety of technical problems of moderate scope and complexity to enable Technology Transfer of various clinical and commercial molecules. Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems. Perform assignments that have clear and specific objectives and require investigation of limited number of variables. Initiate and complete routine technical tasks associated with Technology Transfer. Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting mentorship. Apply engineering principles and statistical analysis, including design of experiments, in-order to address processing issues and evaluate opportunities for process improvements Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or system modifications. Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints. Work with consultants, architects and engineering firms on development of standard design documents. Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments. Support non-standard shift organization and extended hours, as per business needs. Up to 15% travel is possible - primarily domestic (but could be international) What we expect of you We are all different, yet we all use our unique contributions to serve patients. Dynamic professional we seek is an individual with these qualifications.

Requirements

• Master’s degree OR Bachelor’s degree and 2 years of Engineering or Operations experience OR Associate’s degree and 6 years of Engineering or Operations experience OR High school diploma / GED and 8 years of Engineering or Operations experience

Nice To Haves

• Master’s Degree in Chemical or Biochemical Engineering
• Education background in Chemical Engineering, Bioengineering or Biotechnology
• 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of downstream / purification of commercial cGMP manufacturing facilities
• Experience in biologics process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
• Experience working with commercial manufacture of biologics using single use technology
• Basic understanding cGMP requirements
• Experience related to downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities
• Experience in working with design and optimization of downstream processing unit operations including harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules
• Experience in the analysis of data generated from a variety of analytical techniques, troubleshooting, and problem solving
• Regulatory knowledge and interactions
• Project management skills
• Strong oral and verbal communication and presentation skills

Responsibilities

• Responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Amgen manufacturing network and/or Contract Manufacturing Organizations.
• Work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing process in a cGMP environment.
• Provide solutions to a variety of technical problems of moderate scope and complexity to enable Technology Transfer of various clinical and commercial molecules.
• Under general supervision will evaluate, select and apply standard engineering techniques and procedures.
• Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
• Initiate and complete routine technical tasks associated with Technology Transfer.
• Routinely monitor manufacturing processes for performance indicators and operations.
• Suggest problem resolution and provide troubleshooting mentorship.
• Apply engineering principles and statistical analysis, including design of experiments, in-order to address processing issues and evaluate opportunities for process improvements
• Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or system modifications.
• Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
• Work with consultants, architects and engineering firms on development of standard design documents.
• Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments.
• Support non-standard shift organization and extended hours, as per business needs.
• Up to 15% travel is possible - primarily domestic (but could be international)

Benefits

• health and welfare plans for staff and eligible dependents
• financial plans with opportunities to save towards retirement or other goals
• work/life balance
• career development opportunities
• 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: Entry Level
• Number of Employees: 5,001-10,000 employees