drjobs Engineer Biopharma - At-scale biologics purification 9602

Engineer Biopharma - At-scale biologics purification 9602

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Job Location drjobs

Thousand Oaks, CA - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Job Title:Engineer Biopharma Atscale biologics purification(9602
Location:Thousand Oaks CA.
Employment Type: Contract
Business Unit:Process Development Manufacturing Support.
Duration:1 years with likely extensions or conversion to FTE
Posting Date:12/28/2021
Notes:Candidate will be required to be on site 45 days a week and may work remotely 12 days a week.


3 Key Consulting is hiring anEngineerfor a consulting engagement with our direct client a leading global biopharmaceutical company.

Job Description:
We are looking for aProcess Development Engineer to join the Drug Substance Technology Engineering team at our clients 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 purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using singleuse technology. Will partner with manufacturing quality analytical and bench scientists to support a highly dynamic manufacturing facility.


Responsibilities under guidance of senior staff will include:
  • Transfer purification drug substance processes and performs process improvements from the laboratory into the manufacturing facility
  • Provide technical support for successful scaleup 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

Why is the Position Open
Additional workload.

Top MustHave Skill Sets:
  • Atscale biologics purification knowledge and experience
  • Strong understanding of data analysis tools
  • Excellent communication and troubleshooting

Day to Day Responsibilities:
The person in this role will help manufacture clinical and commercial molecules. There are many unique opportunities to work on different programs.

Basic Qualifications:Masters degreeORBachelors degree

Preferred Qualifications:
  • Masters Degree in Chemical or Biochemical Engineering.
  • 1 years of Process Engineering experience preferably related to scaleup principles and commercial cGMP manufacturing facilities.
  • Background in biologics tech transfer into commercial facilities.
  • Upstream process knowledge.
    • Knowledge of cell culture or purification processes/ equipment; scale up factors from mass oxygen transfer capabilities impact of metabolism chromatography UF/DF process deviations raw materials to growth and quality attributes OR
  • Strong capability of analysis troubleshooting and problem solving.
  • Ability to develop and follow detailed protocols.
  • Independently motivated with ability to multitask and work in teams.
  • Excellent written and verbal communication skills with technical writing and presentation experience.
Employee Value Proposition:
The person in this role will help manufacture clinical and commercial molecules. There are many unique opportunities to work on different programs.

Red Flags:

Multiple short duration jobs on resume
No purification experience

Interview process:
Phone and Video Panel Interview

We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.

Employment Type

Full Time

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