Associate Principal Scientist (Biologics)

Location: West Point, Pennsylvania, United States of America; onsite work with flexible work arrangements not applicable

Salary: $142,400–$224,100 annually, plus potential annual bonus and long-term incentive.

Company

hirify.global's Manufacturing Division develops and commercializes biologics and combination products, providing sterile product and process development, technology transfer, validation, regulatory support, and manufacturing investigation capabilities.

What you will do

• Lead cross-functional biologics drug product working groups and manage activities from filing and registration stability through PPQ, approval, launch, and post-launch support.
• Design and execute drug product development, commercialization, process characterization, scale-up, technology transfer, process validation, and new product introduction activities.
• Develop process and product plans, scale-down models, platform engineering and scientific models, control strategies, operating ranges, and in-process controls.
• Drive commercial-site technology transfer, facility fit, PPQ and shelf-life strategies, process optimization, and standardized platforms for liquid, lyophilized, and combination products.
• Influence CMC regulatory strategy, author and review drug product regulatory submissions, and support agency meetings and pre-approval inspection readiness.
• Provide technical oversight, strategic guidance, mentorship, and leadership for complex scientific and manufacturing issues.

Requirements

• Bachelor's degree in chemical engineering, biochemical engineering, bioengineering, pharmaceuticals, biochemistry, microbiology, or a related field with 10 years of relevant experience; or a master's degree with 8 years; or a Ph.D. with 4 years.
• Experience in biologics drug product process development, optimization, and/or process characterization.
• Experience with at-scale biologics drug product manufacturing and fill-finish operations.
• Technical expertise in sterile drug product fill-finish manufacturing processes for large molecules, including laboratory and/or fundamental models for key unit operations.
• Experience transferring and scaling processes to pilot and manufacturing scales, including sterile products transferred to pilot or commercial sites.
• Excellent oral and written communication skills, with the ability to explain process science and support decision-making, impact assessments, and study design in multidisciplinary teams.

Nice to have

• Operations experience manufacturing potent and sterile drug products at pilot or commercial scale.
• Experience with late-stage commercialization of biologics programs.
• Knowledge of regulatory requirements, Quality by Design principles, cGMPs for sterile dosage forms, and current ICH Quality norms.
• Knowledge of DOE and statistical data analysis, statistical process control, multivariate analysis, and/or process analytical technologies.
• Experience in data analytics, computer modeling, and digital applications such as 3-D printing.
• Understanding of analytical methods for characterizing biologics and other sterile drug products.

Culture & Benefits

• High-performance environment emphasizing innovation, learning, empowerment, out-of-the-box thinking, and inclusive collaboration.
• Regular employee status with approximately 10% travel.
• Medical, dental, vision, insurance, retirement, 401(k), paid holidays, vacation, compassionate leave, and sick days.
• Visa sponsorship is available.
• Domestic relocation is listed for the role.

Hiring process

• Applications are submitted through the hirify.global careers portal; current employees and contingent workers use the designated internal application links.
• U.S. and Puerto Rico residents may request accommodation during the application or hiring process.