We are looking for someone to join our Manufacturing Sciences and Technology (MSAT) team as a Sr Process Engineer MSAT. You will be a process SME and be responsible for a diverse range of projects that spans from tech transfer activities to technical manufacturing support and process improvement implementation. This full-time position reports to the Associate Director of MSAT and supports multiple clinical manufacturing facilities in Santa Monica, CA, and Tarzana, CA. Your primary location can be determined based on their residence, with potential travel of up to 10% to meet requirements.

Essential Responsibilities

Provide technical support during clinical production activities, with the objective to deliver the pharmaceutical product on time and in compliance with cGMP, including

On-floor guidance

Troubleshoot and investigation

Product impact assessment

Collaborate with Process Development and Operations to observe manufacturing operations and identify process improvements

Lead change controls for implementation of process improvements

Author and support revisions of technical documentation including protocols, reports, batch records, and SOPs

Complete Technology Transfers (clinical-to-clinical, and development-to-clinical).

Perform process monitoring and interpret development and clinical data

Support regulatory filings, site readiness, and facility startup.

Required Abilities

Experience in new product introductions/manufacturing/ manufacturing science and technology/technical development/quality/R&D.

Experience in Tech transfer, production and engineering.

Comfortable with quality record management and authoring of technical documentation

We are looking for a person who will lead by example and is a team player.

May work outside of normal hours if the business dictates.

Education and Experience

Bachelor's degree, in life sciences, engineering or related field with 8 or more years of experience; Masters degree with 6 or more years of experience; PhD and 3 years of experience.

Experience or an affinity for working in a GMP environment.

#LI-onsite #CellTherapy

The annual base salary for this position ranges from $ 97,175.20 - 145,762 However, 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

15-Jan-2025

Closing Date

09-Feb-2025Our 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.