"Alerted.org

Duration: 05 months contract

**Shift:** Regular Working Hours

Job Description:

+ This senior role balances advanced laboratory execution (cell culture, reagent generation and characterization) with technical leadership of process development, laboratory automation, and digital transformation. You will own medium-to-large improvement projects from problem definition through vendor/technology evaluation, piloting/validation, SOP generation, and handoff into operations while also supporting daily routine tasks.

+ This engagement requires conformance with company’s site policies, safety, quality, and data-integrity requirements. The successful candidate must model company’s mission and the company’s values.

Must Have Skill Sets:

+ Cell bank manufacturing/upstream cell culture processing/mammalian cell culture

+ Laboratory automation/process improvement

+ Technical leadership and teamwork

Key responsibilities include:

+ 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.

Preferred Qualifications

+ 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.

Basic Qualifications:

+ 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.

_Disclaimer:_

_About US Tech Solutions:_

_US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit_** **_www.ustechsolutions.com_** **_._

_US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran._