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Description

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.

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 LN 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.

What we expect of you

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 escalate risks with proposed mitigations.

Basic Qualifications

- Masters degree cell biology molecular biology biotechnology biochemistry or similar and 2 years industry experience in cell culture/process development/reagent generation OR Bachelors 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 Amgen 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.

Job Type & Location

This is a Contract position based out of Thousand Oaks, CA.

Pay and Benefits

The pay range for this position is $45.00 - $47.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Thousand Oaks,CA.

Application Deadline

This position is anticipated to close on Dec 5, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.