Senior Process Optimization Manager
We are seeking a seasoned Senior Process Optimization Manager to join our team. As a key member of our organization, you will be responsible for leading the charge in optimizing drug substance manufacturing processes. Your expertise will drive continuous improvement and ensure high standards for safety, compliance, sustainability, and process excellence.
You will play a pivotal role in supporting our strategic vision for multi-product manufacturing, collaborating with cross-functional teams to align processes with plant capabilities, meet timelines, and achieve production targets.
Key Responsibilities:
* 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.
Requirements:
* 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.
Benefits:
We offer a unique culture that 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.
About Us:
We are driven by a passion for innovation and a commitment to making a difference in the lives of patients with rare diseases.