Senior Scientist, Sterile Liquids Commercialization
- Cork, Ireland
The Sterile Liquids Commercialization group within our Manufacturing Division is based out of West Point PA. It is the division's leader in Sterile Product and Process Development, process scale up, technology transfer. The department is a key enabler of new market authorizations and product launches, while providing technical support and product life cycle management for all injectables in our sterile drug products portfolio. The group is responsible for establishing the science, engineering and knowledge required for today's innovative and accelerated commercialization of novel Vaccines, Biologics, and Pharmaceutical products and combination products.
The Senior Scientist in Sterile Liquid Commercialization organization is a lead drug product scientist responsible to establish and execute commercial process development studies for targeted pipeline and inline programs. Develops robust and scalable manufacturing processes while minimizing time to launch. Implements process improvements to reduce cost structure and enhance robustness process.
Accountabilities and Responsibilities for this position include but are not limited to the following:
- Executes drug product development and commercialization studies, new product introduction and process validation at commercial sites
- Designs and perform experiments to establish robust commercial sterile drug product processes and integrated control strategies
- Leads or attends drug product working groups
- Manages DP activities for in line and pipeline programs, including completion of regulatory filings and product life-cycle management
- Designs and executes process characterization activities. Ensures appropriate design principles including DOE are used where applicable. Ensures fit-for-purpose scale-down models are developed and employed.
- Authors technical protocols for studies, ensures appropriate design of experiments and sample size selection. Ensures acceptance criteria for study outcomes are pre-defined (e.g. performance parameter range, analytical result range etc.)
- Responsible for sample submission and tracking. Employs statistical tools and methods to analyze results
- Authors technical reports that can be used as source documentation for regulatory filing
- Ensures technical information is clearly understood and integrated into decision making
- Authors or performs second-person review (SPR) for high-quality CMC sections for regulatory submissions
- Establishes and validates platform engineering and scientific models for sterile product and process commercialization
- Ensures commercialization programs meet requirements related to science, quality, reliability, schedule and cost
- Applies technical and functional knowledge to design experiments that contribute to overall direction of department/discipline. Uses advanced experience gained on scientific/technical issues to guide others to address non-routine and/or difficult issues
- Serves on cross functional teams to support strategic initiatives
- Drives continuous and phase-appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination products presentations
- Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion
- B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 6 years of relevant experience; or
- Master's degree in Chemical Engineering, Biochemical Engineering, Bio-engineering , Pharmaceuticals, Biochemistry, Microbiology, or related field with 4 years of relevant experience; or
- Ph.D. in Chemical Engineering, Biochemical Engineering, Bio-engineering , Pharmaceuticals, Biochemistry, Microbiology, or related field with relevant academic experience.
- Knowledge in Good Documentation Practices (GDPs)
- Working knowledge of current Good Manufacturing Practices ( cGMPs ) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations
- Experience with utilization of QbD principles to process development and life cycle management
- Experience in Design of Experiment (DoE) and statistical data analysis.
- Experience in authoring and reviewing CMC regulatory documentation .
- Analytical problem-solving skills
- Project management and activities management skills (dashboards, activity trackers)
- Operations experience in the manufacturing of sterile drug products, at pilot and/or commercial scale
- Experience in process optimization, scale-up and technology transfer of sterile products to pilot/commercial.
- Experience in Design of Experiment (DoE) and statistical data analysis.
- Competency in technical writing.
- Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.
- Experience in Data Analytics, Computer Modeling, and Digital Applications (e.g. 3-D printing)
This position may require travel up to 25%; Must be able to travel for this position.
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Our Company., Inc., Kenilworth, New Jersey, USA is known as "Our Company" in the United States, Canada & Puerto Rico. We are known as "Our Company" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
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