Principal Scientist, Engineering - Sterile Drug Product Commercialization, Biologics

Location: West Point, Pennsylvania, United States of America; onsite. Domestic relocation is available. Travel requirements: 10%. Visa sponsorship: Yes.

Base salary: $173,200–$272,600 per year, plus potential annual bonus and long-term incentive.

Company

hirify.global is a pharmaceutical company developing and commercializing biologics and combination products through manufacturing, process development, and technical operations.

What you will do

• Lead and provide oversight for biologics drug product and process design, development, characterization, technology transfer, scale-up, and commercial validation.
• Manage drug product activities through filing, process performance qualification, registration stability studies, approval, launch, and post-launch support.
• Design and execute drug product development, commercialization, new product introduction, process validation, and manufacturing site transfer studies.
• Develop scale-down models, platform engineering models, process control strategies, operating ranges, in-process controls, and shelf-life strategies.
• Influence primary packaging and combination product design, commercialization strategy, continuous process optimization, and manufacturing best practices.
• Author and review drug product CMC regulatory submissions, support agency meetings, and mentor employees on complex scientific and technical issues.

Requirements

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or a related field with 12 years of relevant experience; or a master’s degree with 10 years; or a Ph.D. with 8 years.
• Experience with drug product process development, optimization, and/or process characterization for biologics, including mAbs, ADCs, and/or fusion proteins.
• Experience with at-scale biologics drug product manufacturing and fill-finish operations.
• Experience with late-stage commercialization of biologics programs.
• Technical expertise in sterile drug product fill-finish manufacturing processes for large molecules, including laboratory and/or fundamental models for key unit operations.
• Experience with technology transfer and process scale-up to pilot and/or manufacturing scales.
• Excellent oral and written communication skills and the ability to articulate process science to support decision-making, impact assessments, and study design in multidisciplinary teams.

Nice to have

• Operations experience manufacturing potent and sterile drug products at pilot and/or commercial scale.
• Experience commercializing biologics programs through PPQ and launch.
• Working knowledge of analytical methods and product attributes for biologics.
• Working knowledge of regulatory requirements for sterile drug product commercialization and registration, including Quality by Design principles.
• Working knowledge of current Good Manufacturing Practices for sterile dosage forms and current ICH Quality norms in Manufacturing Science and Technology or Technical Operations.
• Working knowledge of DOE design and data analysis, statistical process control, multivariate analysis, and/or process analytical technologies.
• Experience with data analytics, computer modeling, and digital applications.
• Working understanding of analytical methods for characterizing biologics and other sterile drug products.

Culture & Benefits

• Cross-functional environment focused on innovation, learning, empowerment, high performance, and continuous improvement.
• Medical, dental, vision, and other insurance benefits for employees and families.
• Retirement benefits including a 401(k).
• Paid holidays, vacation, compassionate leave, and sick days.
• Inclusive workplace and equal employment opportunity environment.