Position Summary:
We are looking for an individual 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 is a full-time position reporting to the Associate Director, MSAT. Travel might be required (up to 10%).
Responsibilities:
Provide technical support during clinical production activities, with the objective to deliver the pharmaceutical product on time and in compliance with cGMP, including
1. On-floor guidance
2. Troubleshoot and investigation
3. 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 help with revisions of technical documentation including protocols, reports, batch records, and SOPs
Deliver 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
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 6 or more years of experience; Masters degree with 4 or more years of experience; PhD and 1 years of experience.
Experience or an affinity for working in a GMP environment.
The annual base salary for this position ranges from $103,286 to $154,929. 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).
Our Benefits:
Benefits offered include:
A qualified retirement program [401(k) plan]
Paid vacation, holidays, and paid leaves
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.
#celltherapy #LI-Onsite
Date Posted
18-Mar-2025Closing Date
24-Mar-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.
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