3 Key Consulting

Role Description Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our client 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. Job Responsibilities - 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 operations. Experience in technical report writing is 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 collaborate with other functions such as Manufacturing, Quality, and Regulatory. - Experience related to Process characterization for manufacturing of biologics is highly preferred, including technical support for authoring and review of process characterization reports. Qualifications - Master’s degree and 2 years of Engineering or Operations experience. - Bachelor’s degree and 4 years of Engineering or Operations experience. - Associate’s degree and 7 years of Engineering or Operations experience. - High school diploma / GED and 8 years of Engineering or Operations experience. 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. Top Must Have Skills - Cell culture experience. - Purification/downstream experience. - Process characterization experience. Nice to Have - Monoclonal antibodies or mAbs manufacturing or on-floor support. Day to Day Responsibilities - Assist senior staff in technical writing, process tech transfer, data monitoring. Red Flags - No experience, not enough experience in biopharma or biotech. - No experience in cell culture/upstream, purification/downstream, or technical report writing. Interview Process - Teams interview. - Screening 30-minute Microsoft Teams interview. - Second round - Teams interview, 30 minutes each approximately with 3 other team members. Application Instructions We invite qualified candidates to send your resume to resumes@3keyconsulting.com . If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers . You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description 3 Key Consulting is hiring an Associate Engineer, Drug Product Manufacturing Data Analysis for a consulting engagement with our direct client, a leading global biopharmaceutical company. - Remote but preferably someone who is located near Thousand Oaks or Cambridge sites for occasional onsite. - Dayshift 8AM - 5PM. - Implementation/enhancement of digital systems and automated analysis/visualization tools (Spotfire) that are utilized for streamlining data management and data monitoring. - Data extraction, verification, analysis, and technical reports for process monitoring. - Supporting investigations of adverse signals identified through process data monitoring. - Integration of new products and processes to data monitoring business process and quality management system. - Support for other ad hoc studies and projects as applicable (e.g. technology transfers of processes to new sites). Qualifications - Some industry experience through internship or research projects with a bachelor's degree. - Educational background in engineering, data sciences, biology, chemistry, or related discipline. - Drug product experience in Fill finish or inspection. - Experience with Excel, statistical process control, Spotfire, or Tableau. - Manufacturing experience; strongly preferable for this experience to be in drug product/pharmaceutical field. - Manufacturing experience in other fields may also be considered, depending on relevance of skills involved and transferability/applicability to this position. - Experience with data entry, verification, analysis, and/or data management IS systems. Requirements - Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience. Red Flags - Lack of consistency, focus, or direction (in terms of career trajectory and interests). - Lack of clear interest in or motivation for taking on this specific role. Interview Process - Preliminary phone interview. - Team video interview. Benefits - Pay Rate: $32 - $35/hour W2. - Duration: 1+ year (with likely extensions and/or conversion to permanent).

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description Our ideal candidate will have 3+ years of experience in tech transfer of Biologics Drug Substance upstream and/or downstream required (Cell Culture, Harvest, Chromatography, filtration, UFDF unit ops). - Knowledge of upstream and downstream processes/equipment; scale-up factors, process deviations, quality attributes. - GMP or lab experience is a nice to have. - Strong problem solving and troubleshooting experience would be a plus. Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our client’s Cambridge, MA. site. Providing strong process engineering/technology transfer support of human therapeutic products in clinical development through commercial production. - The Engineer will apply process engineering knowledge in support of upstream and/or downstream 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. Qualifications - Master’s degree OR - Bachelor’s degree and 2 years of Engineering or Operations experience OR - Associate’s degree and 7 years of Engineering or Operations experience OR - High school diploma / GED and 8 years of Engineering or Operations experience Requirements - At least 2 years of Biologics / Drug Substance tech transfer experience required (Cell culture/ harvest/ Chromatography/ filtration/ UFDF unit ops). - At least 2 years of experience in the lab scale development work or in the manufacturing environment (pilot plant or GMP). - Strong analytical capability, troubleshooting, and problem solving skills. Interview Process - Teams screening first - Panel interviews second