Career CategoryEngineering
Job DescriptionPD SENIOR ENGINEERWhat you will doLet'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 (PD DST) at Amgen's FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes development, support, and execution of process validation. The role will be responsible for ensuring process validation activities are performed in a consistent and controlled manner to support manufacture of drug substances. In addition, the role will be responsible for driving PD business strategy activities and providing cross-functional tech transfer support.
- Lead bioburden impact assessment and assess unit operation capability to remove microorganisms or potential by-products and provide operational and engineering advice as part of the overall assessment
- Apply a fundamental understanding of Upstream (Cell Culture) and Downstream (Purification) bioprocessing to provide risk-based approach to microbial assessments
- Acts as manufacturing process subject matter expert to support quality partners and provides operational and engineering understanding to assess the overall capability to clear bioburden and their potential by-products
- Works cross functionally to support draft of microbial impact assessment utilizing risk-based approach.
- Perform trending of bioburden instances within manufacturing space and escalate concerning objectionable microorganisms
- Lead the generation, resolution and closure of PD deviations.
- Support upstream and/or downstream process engineering teams for process monitoring or technical study activities
- Provide process validation support as required for documentation or floor activities
- Manage and mentor an engineer member
- Support ANC PD business strategy activities to improve network practice, develop digital tools, and optimize the ANC PD business operations
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The experienced scientific professional we seek is a leader with these qualifications.
Basic Qualifications:- High school diploma / GED and 10 years of biologics process development, process engineering, or process validation experience OR
- Associate's degree and 8 years of biologics process development, process engineering, or process validation experience OR
- Bachelor's degree and 4 years of biologics process development, process engineering, or process validation experience OR
- Master's degree and 2 years of biologics process development, process engineering, or process validation experience OR
- Doctorate degree
Preferred Qualifications:- 5+ years of experience in an Upstream (Cell Culture), downstream (purification), or process validation role supporting biopharmaceutical processes within regulated environments (i.e., cGMP)
- Strong and in-depth expertise of the operation of upstream or downstream manufacturing processes
- Experience with biopharmaceutical processes including process technical documentation, process monitoring, or large-scale studies
- Experience with bioburden impact assessments in cGMP biopharmaceutical manufacturing
- Independently motivated with successful ability to multi-task and work in teams
- Demonstrated leadership skills and decision-making experience
- Experience with managing
- Experience in process scale-up, technology transfers, EBRs, deviation, CAPA, and change control processes.
- Excellent oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
What you can expect of usAs 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.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
SponsorshipSponsorship for this role is not guaranteed.
Salary Range115,494.60USD -156,257.40 USD
