Director/Principal Scientist, Biologics Drug Substance Commercialization (BDSC)

Location: West Point, Pennsylvania, United States of America. US and Puerto Rico residents only; primary location is USA - Pennsylvania - West Point. Relocation: Domestic. Flexible work arrangements: Not applicable.

Salary: $173,200.00–$272,600.00 annual base salary, plus eligibility for an annual bonus and long-term incentive where applicable.

Company

hirify.global’s Manufacturing Division develops and commercializes biologics drug substance, supporting late-stage pipelines, commercial manufacturing, licensure, and global supply.

What you will do

• Lead upstream and integrated drug substance teams supporting late-stage clinical and commercial biologics programs.
• Direct laboratory- and manufacturing-scale studies for process characterization, validation, investigations, and continued process verification.
• Support technology transfer, scale-up, manufacturing readiness, lifecycle management, and external manufacturing activities.
• Develop, document, and transfer process and product knowledge in line with company standards and regulatory expectations.
• Author and review technical and regulatory documentation, including content supporting regulatory submissions.
• Lead, coach, and mentor upstream scientists while supporting resource planning, staffing, hiring, and talent development.

Requirements

• BS, MS, or PhD in Chemical Engineering, Biological Engineering, Biochemical Engineering, or a related discipline, with 16+ years of relevant industry experience for BS, 12+ years for MS, or 8+ years for PhD.
• Deep technical expertise in cell culture process development and commercialization.
• Experience supporting biologics commercialization, including late-stage development and/or commercial manufacturing.
• Ability to independently design, direct, execute, analyze, and document all stages of process development.
• Ability to prioritize and deliver complex objectives in fast-paced, dynamic environments.
• Strong leadership, collaboration, written communication, and verbal communication skills within cross-functional, matrixed organizations.
• Action-oriented, problem-solving mindset with a track record of innovation and continuous improvement.
• Commitment to coaching and mentoring scientific staff and ability to articulate process science and influence technical decision-making.

Nice to have

• Leadership experience on drug substance working groups or program teams and direct people management experience.
• Hands-on experience with technology transfer, scale-up, and validation of biologics processes.
• Experience with multi-specific antibody therapeutics, including bispecific and other complex antibody formats.
• Experience with late-stage process characterization, viral clearance studies, process performance qualification, and validation.
• Experience authoring regulatory submission content, including BLA sections, and/or working with external development or manufacturing partners.
• Working knowledge of analytical characterization of biologics, cGMPs, and U.S./EU regulatory expectations.
• Experience applying lean leadership and operational excellence principles in laboratory or manufacturing environments.

Culture & Benefits

• Regular employee status with medical, dental, vision, insurance, retirement, 401(k), paid holidays, vacation, compassionate leave, and sick days.
• Annual bonus and long-term incentive eligibility where applicable.
• Work involves approximately 10% travel.
• Inclusive environment focused on diverse perspectives, respectful challenge, collective problem-solving, innovation, continuous improvement, and operational excellence.
• Visa sponsorship is not available.

Hiring process

• Applications are submitted through the hirify.global careers site; US and Puerto Rico residents should use the provided application route.
• Accommodation support is available during the hiring process upon request.