myGwork - LGBTQ+ Business Community · 2 days ago

Engineer III

Cambridge, MA

Full-time

Onsite

Entry, Mid Level

2+ years exp

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Responsibilities

Perform and analyze experiments to generate purification process development for biologic therapeutics.

Contribute to experimental planning for routine studies.

Document experiments in laboratory notebooks.

Transfer production process steps to contract manufacturing organization.

Evaluate new technology with mentoring and oversight.

Write development reports and create departmental presentations.

Apply knowledge of engineering, biology, chemistry, and biomechanical principles to design and evaluate biological systems.

Manage temporary employees for internship or CO-OPS.

Qualification

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BioengineeringBiotech industryAAV purificationBiologics purificationLab analytical analysisChromatography techniquesTFF system operationAseptic operatingGMP trainingTechnical documents authoringTechnical document reviewData analysisManufacturing documents reviewData acquisitionLab managementEquipment managementSafety management

Required

Master’s degree (or foreign equivalent) in a Biology, Bioinformatics, Biochemistry, Microbiology, Biomedical Engineering, or a related field

2 years of experience in a bioengineering-related occupation in the biotech industry

24 months of experience in independently working on AAV or other biologics purification study design, process development, and data analysis

24 months of experience in demonstrating expertise performing lab analytical analysis (including at least 4 of the following: A260/280 nanodrop, pH, conductivity measurement, HPLC, TECAN, or AUC)

24 months of experience in demonstrating subject matter expertise from design to execution of biologics purification using chromatography techniques, experience, and knowledge

24 months of experience in demonstrating subject matter expertise operating TFF system

24 months of experience in demonstrating profound knowledge of aseptic operating and GMP training

24 months of experience in authoring or co-authoring technical documents including at least 1 of the following: electronic lab notebook, technical reports, technical presentations, or scientific publications

24 months of experience in reviewing technical and manufacturing documents, including at least 2 of the following: manufacturing instructions or batch records, process deviations, or process development reports

24 months of experience in executing, collecting, and analyzing data rich experiments acquired from the use of laboratory reactors equipped with data acquisition and control features

24 months of experience in managing temporary employees for internship or CO-OPS

24 months of experience in managing lab, equipment, consumable, and safety