Aptask Global Workforce (AGW) is seeking a Process Development Engineer for a Remote position with a Global Biotechnology Company located in Cambridge, MA. This is a 12+ month contract opportunity. This role will join the Drug Substance Technology Engineering team, providing strong process engineering and technology transfer support for human therapeutic drug substance products from clinical development through to commercial production. The engineer will apply upstream and downstream process engineering knowledge to support technology transfer and manufacturing in both stainless and single-use formats, partnering with manufacturing, quality, analytical, and scientific teams.
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 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 collaborate with other functions such as Manufacturing, Quality, and Regulatory
- Support authoring and review of process characterization reports
Requirements: - 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
Desired skills: - 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)
- Strong analytical capability, troubleshooting, and problem solving
- Independently motivated with ability to multi-task and work in teams
- Excellent written and verbal communication skills with technical writing and presentation experience
Pay range: up to $38.46 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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