Director, Biologics Development and Commercialization Team Lead (CMC Team Lead) (Biologics)

Location: Hybrid role based in West Point, Pennsylvania, or Rahway, New Jersey, United States. Domestic relocation may be available. Travel requirements: 10%. Visa sponsorship is not available.

Salary: $173,200–$272,600 annual base salary for the primary location; annual bonus and long-term incentive may also apply.

Company

hirify.global is a pharmaceutical company developing and commercializing medicines and biologics.

What you will do

• Lead the Development and Commercialization Team for the biologics portfolio and deliver integrated, stage-appropriate CMC development and commercialization strategies.
• Oversee end-to-end deliverables including robust processes and analytics, control strategies, technology-transfer packages, regulatory filing and approval, and commercial supply continuity.
• Own product technical processes and challenges, assess options, prioritize risks, and recommend solutions to governance bodies.
• Represent CMC across governance bodies, stakeholders, and teams while influencing product development strategy and balancing speed, cost, and robustness.
• Lead technical reviews, foster collaborative high-performing teams, and drive accountable, on-time execution.
• Ensure compliance with global and regulatory requirements, current Good Manufacturing Practices, and workplace safety standards.

Requirements

• Bachelor of Science degree in a relevant engineering or science field with 15 years of relevant experience, or Master of Science degree with 12 years of relevant experience, or PhD with 10 years of relevant experience.
• Strong cross-divisional networking skills and capabilities.
• Demonstrated functional and enterprise leadership, with the ability to influence at all organizational levels.
• Strong collaboration skills and the ability to work strategically and in a detail-oriented framework with all levels of management.
• Strong understanding of product management systems and tools, strong business and financial skills, and the ability to manage multiple programs and create a high-performance work environment.
• Expertise in the technical aspects and interdependencies of drug substance, drug product, device, packaging, analytical, regulatory, quality, and supply chain activities from early development through commercial manufacturing.
• Recognized technical leadership and scientific excellence in at least one CMC function, with the ability to navigate uncertainty and complex technical, regulatory, and operational challenges.
• Strategic thinking, enterprise mindset, data-driven problem solving, innovative thinking, productive communication, collaboration, accountability, influence, and ownership.

Nice to have

• Experience in technical product stewardship.
• Track record of successfully commercializing multiple large-molecule programs across a variety of platforms.
• Expert knowledge of global regulatory requirements for large-molecule commercialization and BLA assembly.

Culture & Benefits

• Hybrid work arrangement with a collaborative and inclusive working environment.
• Medical, dental, vision, and other insurance benefits for employees and families.
• Retirement benefits including 401(k).
• Paid holidays, vacation, compassionate leave, and sick days.
• Commitment to safety, compliance, inclusion, and respectful challenge of ideas.