Program Manager II

Role Summary

Program Manager II for GMP Services within the CDMO team responsible for end-to-end management and ownership of GMP Services programs execution at TriLink. Serves as the single point of contact for GMP Services programs, interfacing with Operations, Commercial, Process Development, Quality, Engineering, and other teams to meet customer timelines and milestones. Advocates for the client within the organization, problem-solves to ensure excellent customer service and timely delivery, and fully manages customer contractual deliverables while leading cross-functional project teams.

Responsibilities

• Directs, leads, and motivates multi-disciplinary project teams to deliver GMP Services milestones from pre-Clinical through Commercial phases, while liaising between the customer and internal teams.
• Actively manages up to 3+ small to medium size and complexity customer drug development and manufacturing programs.
• Manages contractual obligations and milestones; flags when additional scope requires a new proposal, Change of Scope, or when there are billing, audit, or other requests.
• Facilitates regular internal and customer-facing meetings with structured agendas, integrated schedules, KPIs, risk/issue management, and timely minutes and action items.
• Maintains accurate project timelines and related tools; identifies and escalates risks and opportunities to keep programs on track.
• Monitors progress to the Statement of Work and resolves open items to ensure milestone delivery; reports progress to leadership.
• Performs other functions and duties as required.

Qualifications

• Bachelor’s degree in Business, Engineering, Life Sciences, or related field; 2–4+ years of relevant experience in customer-facing project/program management and/or technical roles (master’s degree or higher may reduce direct experience to 0–2 years).
• Direct experience in biotechnology/pharmaceutical industry working in pre-IND to late-phase clinical drug substance and drug product development; adjacent CDMO experience may count toward experience.
• Direct experience working within a CDMO managing a client’s program portfolio or operating within a CDMO Project Core Team.
• Working knowledge of CMC considerations with respect to quality systems, GMP, ICH guidelines, FDA, USP, and related regulatory requirements.
• Excellent leadership and interpersonal skills; ability to build relationships in a matrixed environment.
• Project management experience with direct management of projects or portfolio management; proficiency with MS Project, Smartsheet, MS Office, and ERP systems (e.g., NetSuite).
• Experience with manufacture of mRNA and plasmids is a nice-to-have.

Education

• Bachelor’s degree in Business, Engineering, Life Sciences, or related field.