US Tech Solutions · 18 hours ago
Process Development Scientist
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand. They are seeking a Process Development Scientist to balance advanced laboratory execution with technical leadership in process development and laboratory automation. The role involves managing improvement projects, supporting daily tasks, and ensuring compliance with safety, quality, and data integrity requirements.
Responsibilities
Create and characterize adherent and suspension assay cell lines and develop high-quality assay-ready (ready-to-plate) cell banks for cell-based potency assay methods in Process Development (PD) and Quality Control (QC), with a primary focus on adherent mammalian cell lines
Support mammalian cell culture work end-to-end for assay cell bank generation (planning, media preparation, expansion, harvest, cryopreservation, and documentation)
Operate and use WAVE™ 25 Rocker and Corning® HYPERStack® vessels for scale-up culture and banking activities with primary focus on closed-system multi-layer vessels (HYPERStack®) for adherent cell lines
Lead process development and automation projects that increase throughput, reduce variability, and strengthen data integrity for assay cell bank and reagent workflows
Evaluate, pilot and integrate laboratory automation (e.g., liquid handlers, tube handlers, etc.); develop vendor assessments and implementation plans
Author, revise and own SOPs and protocols to enable robust processes and successful transfer to operations
Manage and improve digital inventory workflows; integrate process data to support forecasting and replenishment triggers
Perform and support advanced reagent work: antibody/protein purification and conjugation
Translate research and experimental results into concise technical recommendations and present to cross-functional teams and senior stakeholders
Mentor and provide technical guidance to staff; act as a subject matter expert for GCR operations
Perform inventory management tasks, global shipping, reagent sub-aliquoting, and documentation in accordance with applicable SOPs
Operate lab and automation equipment, including centrifuges, HPLC systems, incubators, freezers, LN₂ dewars, vial fillers, labelers, and cappers
Handle daily tasks and team support while managing projects in a fast-paced setting
Ensure compliance with safety, quality and data integrity expectations
Qualification
Required
Master's degree (cell biology, molecular biology, biotechnology, biochemistry or similar) and ≥ 2 years industry experience in cell culture/process development/reagent generation; OR Bachelor's degree and ≥ 4 years relevant industry experience demonstrating increasing responsibility
Strong hands-on expertise in mammalian cell culture with a primary focus on adherent cell lines; experience with suspension as needed; creation/characterization of cell banks
Strong aseptic technique and experience working in a sterile environment (BSL-2 biosafety cabinets), including routine contamination control
Demonstrated experience leading process improvement and laboratory automation projects from pilot through implementation/transfer
Proficiency with digital lab documentation and data tools (ELN, advanced Excel; data visualization tools such as Spotfire, Tableau)
Proven ability to communicate technical information clearly to peers and senior stakeholders (SOPs, technical summaries, presentations)
Strong mentorship and ability to work effectively in a team and cross-functional environment
Detail-oriented self-starter: independently deliver lab/process-improvement projects; prioritize effectively, meet deadlines, communicate risks with mitigations, and maintain accurate documentation
Ability to work full-time onsite at the company's Thousand Oaks campus
Cell bank manufacturing/upstream cell culture processing/mammalian cell culture
Laboratory automation/process improvement
Technical leadership and teamwork
Preferred
Upstream cell culture processing and cell bank manufacturing experience (preferably assay cell banks with a primary focus on adherent mammalian cell lines; suspension as needed)
Experience working in a GxP-regulated environment
Hands-on experience with reagent development, including antibody/protein purification and conjugation techniques
Practical experience with laboratory automation hardware and software, and knowledge of automation validation/transfer practices
Experience with digital inventory systems and familiarity with SharePoint and Smartsheet
Demonstrated competence with data visualization/analytics tools to analyze and present data (e.g., Spotfire, Tableau, Power BI)
Prior experience authoring SOPs and supporting Quality in regulated environments
Experience mentoring staff and leading technical teams or multi-disciplinary project efforts
Practical use of AI tools, including GenAI
Company
US Tech Solutions
US Tech Solutions counted among the largest yet the fastest growing staffing firm; all achieved organically.
H1B Sponsorship
US Tech Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (9)
2023 (13)
2022 (24)
2021 (18)
2020 (14)
Funding
Current Stage
Late StageRecent News
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2025-05-17
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2024-12-13
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