Sr Manager Engineering
Amgen
- West Greenwich, RI
- $150,855-185,602 per year
- Permanent
- Full-time
- Supervise a team of Process Development Engineers focused on downstream purification processes
- Lead Technology transfers of processes into the site
- Collaborate with Plant Managers, i.e., Production Managers and Senior Process Development staff to assess needs and update progress
- Perform work that involves in-depth investigation of subject area
- Conceive plans and conduct engineering research/investigation in areas of considerable scope and complexity
- Plan, prioritize and coordinate work of a staff of engineers and/or technicians
- Lead efforts with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing recommendations for large and/or highly complex system/facility or process modifications
- Designs, executes, implements, and directs engineering or process projects which significantly contribute to attaining high priority goals
- Interpretation of Processes Characterization
- Establish Testing Strategies
- Design / Development of Characterization Protocols
- Technical Reports Development
- Validations, and technical reports- support SATs executions, document generation and challenge validations strategies
- Risk assessments and QRAES knowledge, to support risk assessments activities
- High school diploma / GED and 12 years of engineering experience OR
- Associate’s degree and 10 years of engineering experience OR
- Bachelor’s degree and 8 years of engineering experience OR
- Master’s degree and 6 years of engineering experience OR
- Doctorate degree and 2 years of engineering experience
- AND in addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
- 8+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing
- Proven ability to lead and deliver results in a highly fluid, interactive matrixed environment
- Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
- Background working with commercial manufacture of biologics
- Strong understanding cGMP requirements
- Knowledge of regulatory filings and inspections
- Downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP) including technical support for nonconformance investigations and other commercial support activities
- Experience working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for biological molecules
- Deep understanding of operational aspects of biopharma and/or engineering industries
- Ability to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
- Skills in analysis of data generated using different analytical techniques
- Strong oral and verbal communication and presentation skills enabling strong relationships with internal and external partners
- Ability to derive insightful strategies to improve business processes
- Experience in supervision of direct reports and mentoring of matrix-team member.
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible