Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
What you will do
Let's do this. Let's change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group at Amgen's FleX Batch Biologics Manufacturing Facility. 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.
Responsibilities include:
Apply fundamental scientific principles to Biopharmaceutical manufacturing processes (downstream purification) in the development of process improvements, facility adaptations, and new process operations.
Provide technical leadership and on-the-floor support to assist in the troubleshooting of clinical and commercial drug substance manufacturing.
Support the GMP manufacturing process tech transfer, evaluations, investigations, innovation and product life cycle management.
Provide support for regulatory filing, inspection, and other CMC activities.
Develop novel mammalian next generation technologies to increase yield, process robustness, and enable new unit operations.
Additional Qualifications/Responsibilities
Basic Qualifications:
High school diploma / GED and 10 years of biologics process development or commercial-scale technology transfer and technical support experience OR
Associate's degree and 8 years of biologics process development or commercial-scale technology transfer and technical support experience OR
Bachelor's degree and 4 years of biologics process development or commercial-scale technology transfer and technical support experience OR
Master's degree and 2 years of biologics process development or commercial-scale technology transfer and technical support experience OR
Doctorate degree
Preferred Qualifications:
4+ years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance manufacturing.
Strong and in-depth expertise in biologics purification processes including chromatography, ultrafiltration and normal flow filtration operations
Experience in process scale-up, technology transfer, facility fit, PPQ support, MFG troubleshooting, and complex investigation
Able to apply engineering principles and statistical analysis, including Quality by Design (QbD) and design of experiments (DoE), in-order to solve processing issues and evaluate opportunities for process improvements
Strong verbal and written communication skills, interact effectively with diverse internal and external stakeholders
Demonstrated ability to work in moderate direction
Be a self-starter with the ability to take on several projects at one time.
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, we'll 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
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Salary Range
115,494.60USD -156,257.40 USD
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: RTX170b99
- Position Id: 97b1ae0e4c3f2994843ff007d7591d20
- Posted 4 days ago
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