Details for the position are as follows:
Downstream Job Details:
- Location: Lexington, MA – Hybrid about 8 days onsite a month
- Rate: $53-55 an hour
- 9-month contract to start with the possibility of extension or conversion depending on performance and business needs
- Hiring for 2 positions (upstream + downstream)
Downstream Job Details:
- As a key member of the Manufacturing Sciences – Downstream Laboratory group, the Downstream Engineer will be responsible for providing technical support of processes for commercial and late-stage clinical production of Biologics, including process and product investigations/troubleshooting, continuous process improvement and life-cycle management, technology transfer and process validation. You will lead or contribute as a key member of various cross-functional teams and will interact extensively with other departments within Takeda, including Manufacturing, QA, QC, PD, Engineering and RA etc.
- Lead and execute continuous process improvements, aimed at improving robustness, capacity, and productivity. Provide technical expertise and leadership in planning, designing and conducting experiments, analyzing data and documenting results towards continuous downstream process improvement, including reducing recurring deviations, and increasing level of safety and/or compliance
- Provide technical expertise and leadership in trouble-shooting and root cause analysis for investigations of complex technical nature
- Provide high quality written study proposals, research and development reports, and investigation reports
- Support implementation of effective and sustainable process control strategy by utilization of Process and Analytical Technologies (PAT)
- As a key member of the Manufacturing Sciences – Commercial Manufacturing Support Laboratory group, this individual will provide technical and scientific support for upstream, clarification, and ultrafiltration processes used in the commercial production of biologics.
- This role is heavily focused on executing process characterization studies, including implementation of ATF (Alternating Tangential Flow) filtration using qualified scale-down models. The individual will collaborate cross-functionally and interact with multiple departments within Takeda Pharmaceutical Company, including Manufacturing, QA, QC, Process Development (PD), Engineering, and Regulatory Affairs (RA).
- Assist in the design and execution of continuous process improvement initiatives aimed at enhancing robustness, capacity, and productivity
- Execute small-scale and pilot-scale studies to evaluate and implement ATF perfusion as a replacement for existing centrifugation processes
- Identify process improvement opportunities and design experiments to evaluate solutions
- Analyze experimental data and document findings to support process optimization
- Contribute to reducing recurring deviations and improving safety, compliance, and operational efficiency
- BS in Biochemistry, Biotechnology, Chemical Engineering or related disciplines with a minimum 1 year of relevant experience in a biotechnology/pharmaceutical environment.
- Upstream and/or Downstream process engineering related experience