Genesis10
About Client
The client is one of the world's largest independent biotechnology companies, focusing on the discovery, development, and manufacturing of innovative human therapeutics. The company's areas of expertise include oncology, hematology, cardiovascular disease, inflammation, bone health, and neuroscience. It has developed a wide range of biologic medicines, including biotechnology drugs, therapeutic antibodies, and other innovative therapies. The company collaborates with academic institutions, biotechnology partners, and other organizations to advance its research efforts.
Job Description The *** Thousand Oaks Global Critical Reagents (GCR) Team is looking for an experienced, hands-on scientist to join the GCR - Process Excellence (GCR-PEX) team. 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 *** site policies, safety, quality, and data-integrity requirements. The successful candidate must model ***'s mission and the company's values.
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 WAVETM 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.
As a senior contributor on GCR-PEX you must deliver both technical excellence and strong collaborative leadership:
Patient-first & integrity: Make decisions that prioritize data integrity, compliance and patient safety. Ensure uninterrupted supply of consistent high-quality critical reagents.
End-to-end ownership: Lead projects through definition, pilot, validation, SOP documentation and handoff; deliver measurable outcomes.
Practical innovation: Suggest actionable, testable improvements while ensuring they meet high standards and can scale effectively.
Clear, influential communication: Present technical findings and business cases to technical colleagues and senior leaders; write clear SOPs and technical summaries.
Mentorship & teamwork: Share expertise, coach junior colleagues, and build cross-functional alignment.
Digital fluency: Use electronic documentation and analytics tools; clearly communicate data and trends.
Time & risk management: Prioritize work effectively, meet deadlines, and elevate risks with proposed mitigations.
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 *** Thousand Oaks campus.
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.
Why this role matters
You will directly influence the reproducibility and reliability of critical reagents that support assays for clinical and commercial product testing across ***'s global network of R&D, PD, and QC.
The role combines hands‑on science, process development, and digital enablement—an opportunity to deliver measurable improvements and to present impact to senior leaders.
Non-benefitted Non-benefitted (other than those mandated under state or federal law). Please note that this position does not include paid time off benefits. ApTask offers subsidized insurance coverage to our employees.
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Job Description The *** Thousand Oaks Global Critical Reagents (GCR) Team is looking for an experienced, hands-on scientist to join the GCR - Process Excellence (GCR-PEX) team. 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 *** site policies, safety, quality, and data-integrity requirements. The successful candidate must model ***'s mission and the company's values.
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 WAVETM 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.
As a senior contributor on GCR-PEX you must deliver both technical excellence and strong collaborative leadership:
Patient-first & integrity: Make decisions that prioritize data integrity, compliance and patient safety. Ensure uninterrupted supply of consistent high-quality critical reagents.
End-to-end ownership: Lead projects through definition, pilot, validation, SOP documentation and handoff; deliver measurable outcomes.
Practical innovation: Suggest actionable, testable improvements while ensuring they meet high standards and can scale effectively.
Clear, influential communication: Present technical findings and business cases to technical colleagues and senior leaders; write clear SOPs and technical summaries.
Mentorship & teamwork: Share expertise, coach junior colleagues, and build cross-functional alignment.
Digital fluency: Use electronic documentation and analytics tools; clearly communicate data and trends.
Time & risk management: Prioritize work effectively, meet deadlines, and elevate risks with proposed mitigations.
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 *** Thousand Oaks campus.
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.
Why this role matters
You will directly influence the reproducibility and reliability of critical reagents that support assays for clinical and commercial product testing across ***'s global network of R&D, PD, and QC.
The role combines hands‑on science, process development, and digital enablement—an opportunity to deliver measurable improvements and to present impact to senior leaders.
Non-benefitted Non-benefitted (other than those mandated under state or federal law). Please note that this position does not include paid time off benefits. ApTask offers subsidized insurance coverage to our employees.
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