Senior Scientist, Sterile Drug Product Commercialization

Job Description

Position Description:

Senior Scientist, Sterile Drug Product Commercialization

The Sterile Drug Product Commercialization group within our Manufacturing Division is based out of West Point, PA and is the division’s leader in Sterile Product and Process Development, process scale up, and 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 is responsible to establish and execute commercial process development studies for targeted pipeline and inline programs and transfers robust and scalable manufacturing processes while minimizing time to launch.

Job Duties include but are not limited to the following:

• Executes drug product (DP) development and commercialization studies, new product introduction and process validation at commercial sites

• Designs and conducts experiments to establish robust commercial sterile drug product processes and integrated control strategies | Leads or attends pharmaceutical product working groups

• Manages DP activities for in line and pipeline programs, including completion of regulatory filings and product life-cycle management

• 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, systematic result range etc.)

• Sample submission and tracking. Employs statistical tools and methods to evaluate results

• Authors technical reports that can be used as source documentation for regulatory filing | Ensures technical information is clearly understood and integrated into result finding

• Conducts second-person review (SPR) for high-quality CMC sections for regulatory submissions

• 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 knowledge gained on scientific/technical issues to guide others to address non-routine and/or difficult issues

• Serves on cross functional teams to promote 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

Position Qualifications:

Education Minimum Requirement:

• B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with six years relevant experience; or

• Master degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with four years relevant experience; or

• Ph.D. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with relevant academic experience

Required Experience and Skills:

• Working knowledge in process optimization, scale-up and technology transfer of sterile or bipharmaceutical processes to pilot/commercial

• Work objectively and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect

• Analytical problem-solving skills

Preferred Experience and skills:

• Knowledge in Good Documentation Practices (GDPs)

• Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and ICH guidelines

• Expertise with utilization of QbD principles for process development

• Expertise in authoring and reviewing CMC regulatory documentation

• Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.

NOTICE FOR INTERNAL