Introduction to role
Neogene is seeking a motivated Process Engineer II with expertise in cell therapy to join our Manufacturing Sciences and Technology (MSAT) team. This role will support the production of clinical manufacturing products using a variety of modalities (autologous, allogeneic, TCR-T, and CAR-T). The process engineer will be a key subject matter expert supporting these clinical programs by providing manufacturing troubleshooting inputs and direction, authoring quality non-conformances and evaluations, and supporting technology transfers and process improvements. The successful candidate will have knowledge of basic engineering principles, cell therapy operations, and cGMP manufacturing. This role is based in Santa Monica, CA, and reports to the Associate Director, MSAT. There may be occasional project-specific travel requirements (<10%).
Accountabilities
- Author and manage deviations, root cause analyses, product impact assessments, and change controls via the Quality Management System.
- Propose process and operational optimizations for ongoing cGMP manufacturing processes. Involves cell culture in multiple formats including flasks, bags, and bioreactors, and both non-viral and viral gene editing.
- Support technology transfer activities, leading cross-functional designees to coordinate Tech Transfer plan activities. Includes training oversight of new process steps to the manufacturing team (in collaboration with Process Development), authoring supporting protocols and summary reports and required risk assessments.
- Collaborate within the team to contribute to technical discussions.
- Review experimental proposals from Process Development, and cGMP batch records and SOPs for clinical manufacturing.
- Perform Person-In-Plant (PIP) duties for on-the-floor support of critical steps (when required).
- Perform other duties and special projects as assigned.
Essential Skills/Experience
- Experience in cell and gene therapy or biologics manufacturing operations (required).
- Hands-on experience in cell and gene therapy (preferred).
- Knowledge of cGMP manufacturing and regulations and practical experience in GMP operations (required).
- Knowledge of QbD, DOE, and statistical analysis tools (e.g., JMP, MiniTab) (preferred).
- Ability to think critically, analytically and have demonstrated troubleshooting and problem-solving skills based on deductive reasoning (required).
- Strong verbal and written communication skills, including technical writing (required).
- MS degree in Biochemical Engineering, Biomedical Engineering, Biotechnology or related field with 2+ years relevant industry experience or BS degree with 4+ years relevant industry experience.
Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Sit and talk or hear.
- Frequently use hands to finger, handle, or feel.
- Occasionally stand, walk, and reach with hands and arms.
- Occasionally lift and/or move up to 10 pounds.
- Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.
- The noise level in the work environment is usually moderate.
- This position requires working with biological and/or chemical hazards.
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, you'll be part of leading our Operations function at an exciting time of growth and evolution. We pioneer new approaches and processes across our sites, empowering our teams to foster a Lean mindset and sustainable practices. Every change we make is to deliver better outcomes for our patients. Adaptable and agile, we are open to others' views and draw on the diverse expertise of our teams. With cross-functional working practices, we have the guidance we need to flex and evolve to better overcome any obstacles.
Ready to make a difference? Apply now!
The annual base pay for this position ranges from $95,446 to $143,169. 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.
Date Posted
22-Oct-2024Closing Date
25-Nov-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
