Upstream Drug Substance Engineer — Scale-Up & Transfer

BioSpace; Thousand Oaks (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen in Thousand Oaks is seeking an Engineer to join the Drug Substance Technology Engineering team supporting Amgen Thousand Oaks Drug Substance Manufacturing facilities. Transfer cell culture drug substance processes from lab to manufacturing and between sites; provide on-the-floor process validation support; assist scale-up and process transfer.

You will monitor processes, perform data trending and analysis, contribute to deviations and CAPAs, and collaborate with Manufacturing, Quality, and

Qualifications

• Masters degree
• OR
• Bachelors degree and 2 years of Process Development experience
• OR
• Associates degree and 6 years of Process Development experience
• OR
• High school diploma / GED and 8 years of Process Development experience
• Masters degree in Chemical/Biochemical Engineering or related subject area
• 3+ years of experience in Process Engineering related to biochemical engineering and/or protein biochemistry
• Upstream process knowledge and hands on cell culture and/or purification pilot/clinical/commercial experience with regard to the manufacture of a biological drug substance
• Experience working in/supporting a commercial cGMP manufacturing facility
• A firm understanding of cell culture process and related equipment; scale-up from bench to commercial scale
• Knowledge of aseptic processing/techniques, harvest and clarification processes used in mammalian cell culture processes AND/OR a good understanding of purification process and associated equipment
• Process development (PD) experience supporting cGMP manufacturing at large scale
• Strong capability in scientific/engineering/laboratory analysis, troubleshooting and ability to apply sophisticated problem resolution abilities
• Ability to develop and follow detailed protocols
• Independently motivated with ability to multi-task and work in teams
• Excellent written and verbal communication with experience with technical writing and presentations

Responsibilities

• Transfer cell culture drug substance processes and perform process improvements from the laboratory into the manufacturing facility and between manufacturing sites
• Provide process validation support for late stage commercial processes
• Provide on-the-floor technical support for successful scale-up and transfer of process technology, and for clinical or commercial manufacturing operations
• Provide routine process monitoring and troubleshooting
• Perform data trending and statistical process analysis
• Provide technical contributions for process related deviations (NCs), CAPAs and change controls
• Identify and support process related operational excellence opportunities
• Represent process development and collaborate with other functions such as Manufacturing, Quality, and Regulatory

Skills

Excellent written and verbal коммуника

Multi-tasking

Team collaboration

Troubleshooting

Problem resolution

Independent motivation

Education

Masters degree

Bachelors degree and 2 years of Process Development experience

Associates degree and 6 years of Process Development experience

High school diploma / GED and 8 years of Process Development experience

Job description

Amgen in Thousand Oaks is seeking an Engineer to join the Drug Substance Technology Engineering team supporting Amgen Thousand Oaks Drug Substance Manufacturing facilities. Transfer cell culture drug substance processes from lab to manufacturing and between sites; provide on-the-floor process validation support; assist scale-up and process transfer.

You will monitor processes, perform data trending and analysis, contribute to deviations and CAPAs, and collaborate with Manufacturing, Quality, and