Associate Director, CMC / Quality Project Management (Biologics)

Location: Princeton, New Jersey, United States. Limited travel may be required, including global travel and meetings across different time zones.

Salary: $174,000–$204,000 USD annually, with potential bonus, stock, benefits, and other variable compensation.

Company

hirify.global is a biopharmaceutical oncology company developing investigational therapies and conducting global Phase 3 studies in non-small cell lung cancer and colorectal cancer.

What you will do

• Lead CMC and Quality program management across biologics development from early clinical phases through BLA/MAA submissions and post-approval changes.
• Represent Program Management on cross-functional teams and align CMC deliverables with program milestones, product target profiles, and regulatory expectations.
• Develop submission plans, integrated timelines, dashboards, risk mitigation strategies, decision memos, and governance materials.
• Manage clinical supply planning, including forecasts, vendor plans, supply dependencies, inventory, expiry, cost, and continuity of dosing.
• Oversee CDMO/CMO performance for drug substance, drug product, and analytical testing, including KPIs, deviations, CAPAs, and escalated risks.
• Lead external collaboration planning, governance, issue resolution, decision rights, milestones, and escalation pathways.

Requirements

• Bachelor’s degree in life sciences, chemistry, engineering, or a related field required; an MS, PharmD, PhD, or MBA is desirable.
• 8+ years of pharmaceutical or biotech industry experience, including substantial CMC development, late-stage biologics, and BLA/MAA regulatory filing preparation.
• Prior pharmaceutical drug development experience required, including late-stage development through commercialization.
• Proven success leading global, matrixed, cross-functional teams in a regulated environment.
• Strong integrated project planning, risk management, resource allocation, and budget oversight skills; PMP certification and experience with Smartsheet, MS Project, Power BI, or Office Timeline are beneficial.
• Proficiency with Microsoft Office, electronic document management systems, and document review tools, with the ability to quickly prepare leadership presentations.
• Excellent public-speaking, meeting facilitation, written, and email communication skills.
• Ability to work effectively in a fast-paced, demanding, and diverse environment.

Nice to have

• Advanced degree such as MS, PharmD, PhD, or MBA.
• Late-stage biologics, oncology, GMP, manufacturing, and global regulatory supply-chain experience.
• Professional proficiency in Mandarin to support communication with overseas collaborators.

Culture & Benefits

• Work in a collaborative, matrixed environment focused on oncology clinical development and serious unmet medical needs.
• Work with global external partners and participate in virtual meetings across different time zones.
• Limited travel may be required, including the ability to travel globally and meet Chinese visa requirements.
• Total compensation may include bonus, stock, benefits, and other applicable variable compensation.
• Summit is an equal opportunity employer committed to a diverse workplace.