We are seeking a highly motivated individual to join our Manufacturing Sciences and Technology (MSAT) team as a Sr Process Engineer MSAT. The ideal candidate will serve as 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. The candidate’s primary location can be determined based on their residence, with potential travel of up to 10% as needed to meet business requirements.

Essential Functions and 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
  • Troubleshooting and investigation
  • Product impact assessment
• Collaborate cross-functionally with Process Development and Operations to observe manufacturing operations and continuously identify process improvements
• Lead and support change controls for implementation of process improvements
• Author and assist in revisions of technical documentation including protocols, reports, batch records, and SOPs
• Lead and execute 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 as needed

Required Skills/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
• A strong sense of urgency with regards to work duties and the ability to deliver results based on challenging timelines.
• Strong verbal and written communication skills and the ability to communicate results to a diverse cross-functional audience.
• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.
• We are seeking a person who will lead by example and is a self-motivated team player with strong interpersonal skills.
• May be required to 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.
• Industry experience is preferred.

Date Posted

13-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.