Master’s Degree in Chemical or Biochemical Engineering
2+ years of Process Engineering experience related to downstream/purification
Excellent written and verbal communication skills
Requirements:
Transfer 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
Support technical direction for process-related deviations, CAPAs, and change controls
Job description
Duration: 12 months contract
Job Description:
Remote (Any TZ - Local to Cambridge, MA is highly preferred.
Ideal candidate: B.S. and 4 YOE or M.S. and 2 YOE would be ideal. Manager highly prefers candidates with a M.S. and 2 YOE.
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 drug substance 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. Knowledge of processes/equipment; scale-up factors, process deviations, quality attributes. GMP experience is a plus
The Engineer will apply upstream and downstream 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.
Responsibilities:
Under guidance of senior staff, the Engineer will perform the following:
Transfer 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. Experience is technical report writing an expectation.
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.
Preferred Qualifications:
Master’s Degree in Chemical or Biochemical Engineering
2+ years of Process Engineering experience preferably related to downstream/ purification of commercial cGMP manufacturing facilities
Background in biologics technology transfer into commercial facilities, new product introductions (NPIs)
Biologics purification process knowledge: Knowledge of upstream ( cell culture/bioreactor operations) or purification processes (chromatography, viral filtration/inactivation, ultrafiltration/diafiltration, and final fill. )/ equipment; scale-up factors, process deviations, quality attributes
Strong analytical capability, troubleshooting, and problem solving
Independently motivated with ability to multi-task and work in teams, especially if remote or hybrid.
Excellent written and verbal communication skills with technical writing and presentation experience. Experience in PC documentation, report reviews and technical writing preferred.
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
Top 3 Must Have Skill Sets:
Cell culture experience, Purification /downstream experience, process characterization experience
Nice to have:
Monoclonal antibodies or mAbs
manufacturing or on floor support
About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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