Process Engineer, MSAT Contractor

1 week ago

Waltham, United States ElevateBio Full time

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role:

As a Process Engineer (Contractor) in Manufacturing Science and Technology, you will provide technical support for GMP manufacturing, technology transfers, validation, and continuous improvement projects within a highly matrixed cross functional team for Base Camp programs. As part of support, you will write protocols, product impact assessments, root-cause analysis reports, sampling plans, technical reports. You will support data collection and charting for non-GMP and GMP batches.

This is a 4-month contract.

Here's What You'll Do:

  • Working cross-functionally across Process Development, Manufacturing, Supply Chain, Regulatory Sciences and Quality to provide support for technology transfers and process changes in a cGMP environment.
  • Authoring and reviewing technical documentation related to manufacturing activities including protocols, technical reports, manufacturing batch records, SOPs, change controls, deviations, regulatory submissions, and product impact assessments.
  • Assist in the root cause determined of process related deviations in a timely and conclusion manner. The Candidate will work with a cross functional team to resolve complex problems and deviations using experience and the efficient application of scientific methodology and technical reasoning.
  • Support gap analyses and risk assessments to support the capital projects and tech transfers.
  • Assist in execution of Process Validation activities or other site initiatives including authoring protocols and reports.
  • Assist in development of data-based process performance monitoring systems.
  • Perform process data-driven deviation resolution and improvement projects.
Requirements:
  • BS/MS/PhD in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 5+/3+/1+ years of relevant experience
  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture.
  • Op with cGMP manufacturing and regulatory regulations and requirements.
  • Drug manufacturing experience required. Use of LOVO, Sepax, Rotea, CliniMACs devices, automated fillers preferred.
  • Experienced with leading investigations, writing, deviation reports, change controls, and corrective actions
  • Ability to share complex principles of knowledge to others (team member, stakeholder, external, or inspection) along with strong technical writing abilities
  • Experience working in cross functional teams to obtain project deliverables
  • Knowledge of data management tools and statistical process controls


Why Join ElevateBio?

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms - including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform - with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.

Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

Our Vision:
We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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