Engineer, Tech Transfer/Cell Culture & Purification - (JP11993)

Thousand Oaks, CA - USA

Hourly Salary: $ 37 - 41

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Engineer Tech Transfer/Cell Culture & Purification - (JP11993)
Location: Thousand Oaks CA. 91320 (Hybrid)
Business Unit: Drug Substance Technology Engineering
Employment Type: Contract
Duration: 1 years (with possible extensions)
Rate: $37 - $41/hour W2
Posting Date: 11/15/2023
Notes: Only qualified candidates need apply. HYBRID 3/4 days onsite 1-2 remote

3 Key Consulting is recruiting an Engineer Tech Transfer/Cell Culture & Purification for a consulting engagement with our direct client a leading global biotechnology company.

Job Description:
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.

Candidate will be required to be on site 3-4 days a week and may work remotely 1-2 days a week (activities permitting).
Must have biotech background/experience plus must have cell culture/purification experience
The ideal candidate:
- Has experience in a dynamic fast based manufacturing environment adaptability.
- Can jump around and pivot in their role with ease
- Can sit in an open office and collaborate with team.
- Understand the language and compliance in a large scale manufacturing plant
- Trouble shoot problem solving and data analysis.
- Great communicator good technical witting and presentation experience
- Minimum Bachelor degree and 2 years of experience with antibodies or biologics.

Top Must Have Skill Sets:

Cell culture bioreactors - monitoring of at-scale bioreactor process/equipment. Or
Purification processes/ equipment; chromatography UF/DF Ultra filtration and Dia filtration.
Experience working in a GMP plant and quality systems

Day to Day Responsibilities:

Provide on-the-floor technical support for successful scale-up transfer of process technology and for clinical and/or commercial manufacturing operation
Provide routine process monitoring and troubleshooting
Perform data trending and statistical process analysis
Provide technical support for process related deviations (NCs) CAPAs and change controls
Identify and support process related operational excellence opportunities
Represent process development and interface with other functions such as Manufacturing Quality and Regulatory

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

Basic Qualifications:

Master degree OR
Bachelor degree and 2 years of experience OR
Associate degree and 6 years of experience OR
High school diploma / GED and 8 years of experience

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

Why is the Position Open
Planned Project

Red Flags:

Wants remote work only.
No on-the-floor support experience.
No scientific background.
Only pharmaceutical and no biologics experience.
No cell culture or protein purification experience.
no process dev or process engineering

Interview Process:

Phone interview 1:1 start screening ASAP.
1:3 panel or series of 1:1s

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

Regards

3KC Talent Acquisition Team

Job Title: Engineer Tech Transfer/Cell Culture & Purification - (JP11993)Location: Thousand Oaks CA. 91320 (Hybrid)Business Unit: Drug Substance Technology EngineeringEmployment Type: ContractDuration: 1 years (with possible extensions)Rate: $37 - $41/hour W2Posting Date: 11/15/2023Notes: Only quali...

Candidate will be required to be on site 3-4 days a week and may work remotely 1-2 days a week (activities permitting).
Must have biotech background/experience plus must have cell culture/purification experience
The ideal candidate:
- Has experience in a dynamic fast based manufacturing environment adaptability.
- Can jump around and pivot in their role with ease
- Can sit in an open office and collaborate with team.
- Understand the language and compliance in a large scale manufacturing plant
- Trouble shoot problem solving and data analysis.
- Great communicator good technical witting and presentation experience
- Minimum Bachelor degree and 2 years of experience with antibodies or biologics.

Top Must Have Skill Sets:

Cell culture bioreactors - monitoring of at-scale bioreactor process/equipment. Or
Purification processes/ equipment; chromatography UF/DF Ultra filtration and Dia filtration.
Experience working in a GMP plant and quality systems

Day to Day Responsibilities:

Provide on-the-floor technical support for successful scale-up transfer of process technology and for clinical and/or commercial manufacturing operation
Provide routine process monitoring and troubleshooting
Perform data trending and statistical process analysis
Provide technical support for process related deviations (NCs) CAPAs and change controls
Identify and support process related operational excellence opportunities
Represent process development and interface with other functions such as Manufacturing Quality and Regulatory

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

Basic Qualifications:

Master degree OR
Bachelor degree and 2 years of experience OR
Associate degree and 6 years of experience OR
High school diploma / GED and 8 years of experience

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