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At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Engineer
What you will do
Lets do this! Lets 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.
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 - domestic and international
Additional Qualifications/ResponsibilitiesWhat we expect of you
We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is an Engineer with these qualifications.
Basic Qualifications:
High school diploma / GED and 8 years of Engineering or Operations experience OR
Associates degree and 6 years of Engineering or Operations experience OR
Bachelors degree and 2 years of Engineering or Operations experience OR
Masters degree
Preferred Qualifications:
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 biopharmaceutical manufacturing processes.
Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
Experience working with commercial manufacturer of biologics using single use technology
Basic understanding cGMP requirements; Experience related to upstream and/or 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 pharmaceutical processing unit operations including cell expansion harvest clarification Protein A MMA CEX Viral Filtration UFDF and sterile filtration among others for a variety of biological molecules. Experience working with data and digital tools preferred.
Proficient re: the analysis of data generated from an array of analytical techniques
Regulatory knowledge and interactions and project management skills
Strong oral and verbal communication and presentation skills
Fluency in foreign languages preferred
What you can expect of us
As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.
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.
In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of 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 that may include:
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
Salary Range
95914.00 USD - 116069.00 USD