Are you ready to lead the charge in optimizing drug substance manufacturing processes? As a Senior Manager, Lead Process Engineer, you'll be at the forefront of driving continuous improvement and ensuring high standards for safety, compliance, sustainability, and process excellence.
You'll play a pivotal role in supporting Alexion's strategic vision for multi-product manufacturing at College Park, collaborating with NPI Project Teams to align processes with plant capabilities, meet timelines, and achieve production targets.
Your expertise will guide stakeholders in Manufacturing, Engineering, and Quality to enhance existing processes and optimize plant performance and throughput.
Accountabilities:
Identify and implement process optimization/process safety projects throughout the facility.
Manage and coordinate a portfolio of process engineering projects.
Serve as Process SME on all manufacturing processes within the Bulk Drug Substance facility at College Park.
Review design/specification of equipment and systems to ensure compliance with regulations and compatibility with the existing BDS facility.
Evaluate new Process Equipment and NPI processes for long‑term operability of the plant.
Assess New Product Introduction Design Changes to prevent impacts on existing manufacturing processes.
Collaborate with other discipline leads on process issues and lead a team of engineers in identifying solutions.
Own process‑related aspects of projects, providing technical support to the design team.
Build relationships with key stakeholders within the facility to ensure completion of critical projects and initiatives related to BDS manufacturing.
Support Global teams in Basis of Design and Facility Fit studies for future site capability.
Assist in regulatory inspections for both new and existing process equipment.
Develop a long-term strategy for optimization projects based on business forecasting.
Oversee planning and execution of process optimization testing on live equipment safely and compliantly.
Champion safe working practices and safety initiatives within their functional area.
Essential Skills/Experience:
Minimum 8 years of experience in a relevant technical or managerial role within the Bio Pharma industry, focusing on Drug Substance Process Optimization/Design.
Ability to manage a wide portfolio of projects and prioritize as required by the business.
Excellent technical abilities with a base in engineering.
Ability to keep work pace and meet deadlines.
Good organization and planning skills.
Strong leadership and communication skills.
Problem solver with a focus on achievement of overall project goals.
Ability to work independently with minimum direct supervision.
Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
Must be goal‑oriented and able to prioritize and manage tasks.
Desirable Skills/Experience
Technical Degree or higher in Engineering.
Experience in managing technical teams.
Lean accreditation.
At Astra Zeneca, we are driven by a passion for innovation and a commitment to making a difference in the lives of patients with rare diseases.
Our unique culture fosters collaboration, creativity, and growth, empowering you to explore new ideas and develop your skills.
With a rapidly expanding portfolio, you'll be part of an energizing environment where your contributions have a meaningful impact.
Join us in our mission to change lives for the better, supported by exceptional leaders and peers who are dedicated to advancing healthcare.
Ready to make an impact? Apply now and be part of our journey
Date Posted
28-Nov-2025
Closing Date
11-Dec-2025
Our mission is to build an inclusive and equitable environment.
We want people to feel they belong at Astra Zeneca 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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