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Upstream Engineer
Job Description
Target PR Range: 30-40/hr
*Depending on experience
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 cell culture and/or 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.
JOB RESPONSIBILITIES:
Under guidance of senior staff, the Engineer performs the following:
- Transfer cell culture and/or 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
PREFERRED QUALIFICATIONS:
• Bachelor degree Chemical or Biochemical Engineering and 2 years of experience GMP Environment
• 1+ years of Process Engineering experience preferably related to scale-up principles and commercial cGMP manufacturing facilities
• Background in biologics tech transfer into commercial facilities
• Cell culture and/or Purification process knowledge:
- Knowledge of purification processes/ equipment; scale up factors from, chromatography, UF/DF, process deviations, raw materials to growth and quality attributes
- Knowledge of cell culture processes/ equipment; scale up factors from, mass oxygen transfer capabilities impact of metabolism, process deviations, raw materials to growth and quality attributes
• Strong capability of analysis, troubleshooting and problem solving
• Ability to develop and follow detailed protocols
• Independently motivated with ability to multi-task and work in teams
• Excellent written and verbal communication skills with technical writing and presentation experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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