Director, External Capabilities, Analytical Capabilities and Operations (ACO)

Location: Rahway, New Jersey, United States of America, or West Point, Pennsylvania, United States of America. Onsite role with up to 10% domestic and/or international travel. Domestic/international relocation is available. Visa sponsorship is available.

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

Company

hirify.global develops pharmaceutical products and supports large-molecule drug development, clinical supply, and commercialization.

What you will do

• Lead a group of approximately 10–12 scientists supporting externalized analytical deliverables for biologics, antibody-drug conjugate, and vaccine programs.
• Execute the externalization strategy and optimize the operating model in alignment with enterprise goals.
• Oversee quality control deliverables for drug substance and drug product at external partners, including analytical method qualification, transfers, and resolution of GMP issues.
• Build external analytical capabilities by working with internal subject-matter experts to upskill strategic partners.
• Oversee method transfers to commercial quality-control laboratories in support of registrational targets.
• Partner with Process, Quality Assurance, Manufacturing, and ACO leadership to maintain high-quality documentation, develop talent, and bring pipeline candidates toward patients and commercialization.

Requirements

• Ph.D. degree with at least 8 years of experience, or a master’s degree with at least 10 years of experience, or a bachelor’s degree with at least 15 years of experience.
• Strong knowledge of the biologics CMC landscape, including GMP and relevant health-authority guidelines.
• Experience with a wide variety of analytical methods, including microbiological, device, potency assay, biochemical, and/or biophysical characterization.
• Experience at the development/commercialization interface with a track record of moving pipeline assets to commercial products.
• Project management experience, including resource management, budget forecasting, and risk assessment and mitigation planning.
• Outstanding communication, critical thinking, negotiation, and data-driven decision-making skills.
• Demonstrated ability to work across networks and deliver results in a fast-paced, dynamic environment.

Nice to have

• Additional experience across large-molecule analytical method development and qualification.
• Experience managing relationships with strategic external partners and developing scientific talent.

Culture & Benefits

• Inclusive environment that brings together diverse experiences, perspectives, skills, and backgrounds.
• Collaborative culture that encourages respectful challenge and collective problem-solving.
• 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.
• Regular employee status with potential annual bonus and long-term incentive eligibility.