Engineer - Aditi Consulting
Thousand Oaks, CA
About the Job
Summary:
Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Cambridge site. Providing strong process engineering/ technology transfer support of 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 purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in both stainless and single-use formats. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic technology transfer.
Day to Day Responsibilities:
Top 3 Must Have Skill Sets:
Ideal candidate:
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Cambridge site. Providing strong process engineering/ technology transfer support of 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 purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in both stainless and single-use formats. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic technology transfer.
Day to Day Responsibilities:
- Transfer purification processes for drug substance manufacturing and translate process improvements from the laboratory into manufacturing facilities
- Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
- Assist in troubleshooting clinical and commercial runs
- 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
Top 3 Must Have Skill Sets:
- Purification/"downstream" laboratory (PD) or MFG experience with monoclonal antibodies, HR/EWC can look for keywords such as chromatography, filtration, UFDF, UF/DF, final fill, viral filtration, viral inactivation.
- Technology Transfer/NPI experience is a plus.
- PPQ experience is a plus
Ideal candidate:
- 1-2 years of industry experience, comfortable presenting.
- Biologics/ drug substance purification experience required (Chromatography, filtration, UFDF unit ops)
- Knowledge of purification processes/equipment; scale-up factors, process deviations, quality attributes.
- GMP experience is a huge plus.
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
Source : Aditi Consulting