Neogene is seeking a highly motivated researcher, to join the Process Development team, as Scientist, supporting and contributing to the design and execution of studies to develop and optimize clinical manufacturing processes of Neogene portfolio of engineered T cell therapies. Based in Santa Monica, CA, this role reports to the Senior Scientist, Process Development.
Essential Functions and Responsibilities
Design and execute experiments to develop and optimize robust and scalable manufacturing processes for manufacture of genome engineered T cell products.
Conduct thorough characterization studies to understand process and product quality attributes for cell therapy drug product manufacturing.
Collect and analyze experimental data and generate clear and concise reports summarizing findings and recommendations. Collaborate within the project team to interpret study results and contribute to technical discussions for subsequent study design.
Collaborate closely with cross-functional teams, including research/development scientists, manufacturing personnel, and quality control, to ensure seamless technology transfer from process development to manufacturing. Effectively communicate project updates, results, and strategies to collaborators and team members
Stay up to date with the latest scientific advancements and emerging technologies in cell therapy process development. Help evaluate and implement new technologies and methodologies to enhance process efficiency and productivity.
Maintain accurate and detailed laboratory notebooks and electronic records in compliance with company policies and regulatory requirements. Prepare and review technical documents, including standard operating procedures (SOPs), batch records, and development reports, as needed.
Work effectively in a team environment to meet project timeline and objectives.
Perform other duties as assigned.
Required Skills/Abilities
At least 3 years of demonstrated hands on experience in developing production processes for genome engineered primary cells (required) including T cells (highly preferred).
A minimum of three (3) years practical experience with Flow Cytometry.
Hands-on experience performing analytical methods typically used in the manufacture and characterization of biological products.
Proficiency with Microsoft Excel or statistical analysis software (JMP, Minitab, Prism, etc.) for analyzing and presenting data.
Working understanding of US/EU regulatory requirements and working knowledge of cGMPs.
Ability to think critically, analytically and have demonstrated troubleshooting and problem-solving skills based on deductive reasoning.
Ability to design and implement experiments with minimal technical supervision.
Strong organizational and time management skills, with the ability to prioritize and manage multiple projects simultaneously.
PhD degree in Immunology, Cell Biology, Molecular biology, Bioengineering, or relevant degrees or similar MS degree with 3+ years proven experience or similar BS degree with 5+ years relevant experience within the pharmaceutical or biotech industries.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we take Quality seriously. We are constantly innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We are proactive, science-based, and solutions-oriented. Our focus is on scaling and introducing new technologies, using models to predict and proactively manage risk. We are strong communicators and networkers, working together as a team to get our pipeline out to patients sustainably, reliably and safely. We follow evidence to reach outcomes that benefit patients and AstraZeneca.
Are you ready to make a real-life difference to patients? Join us at AstraZeneca where we have built an unrivalled reputation in Quality, through our 'Total Quality' culture that takes us beyond pure compliance. Apply now!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
The annual base pay (or hourly rate of compensation) for this position ranges from $87,200 to $130,800. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
