Process Development Engineer
Job Description
Description:
*Candidate will be required to be onsite 4-5 days a week and may work remotely 1-2 days a week.
*Candidate will be required to work Standard business hours with occasional after hour support
** Some after hours work may be required
Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Thousand Oaks facility. Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.
The Engineer will apply harvest and purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.
Top 3 Must Have Skill Sets:
- ** 2 YOE post graduation required
- At- scale biologics purification knowledge and experience
- Strong understanding of data analysis tools
- Excellent communication and troubleshooting
Day to Day Responsibilities:
- Staff will perform tech transfer of earl clinical candidate molecules
- In addition staff will support all processes (clinical and commercial) executed in the facility, performing process monitoring and responding to issues as appropriate
JOB RESPONSIBILITIES:
Under guidance of senior staff, the Engineer performs the following:
Transfer purification drug substance processes and performs process improvements from the laboratory into the manufacturing facility
Provide technical support for successful scale-up, transfer of process technology, and for clinical and /or commercial manufacturing operation
Offer process validation support for late stage commercial processes
provide routine process monitoring and troubleshooting
Execute data trending and statistical process analysis
Support technical direction for process related deviations, CAPAs and change controls
Identify and support process related operational excellence opportunities
represent process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory