CMC Program Manager/Senior Program Manager

Barrington James; San Jose (CA); On-site; USD 170,000 - 210,000; Full time

Job summary

Qualifications

• Requires degree in Life Sciences, Chemistry, Engineering or Business (advanced degree advantageous).
• 5+ years' experience in CMC development and project management in pharma/biotech.
• Experience supporting small molecule development across clinical to submission.
• Proven ability to lead cross-functional planning, execution and decision-making.

Responsibilities

• Develop and govern CMC program governance with meetings, reporting, and decision processes.
• Prepare materials, track risks/issues, and ensure escalation and follow-up.
• Build integrated project plans with milestones, dependencies, and regulatory deliverables.
• Coordinate cross-functional execution across Drug Substance, Drug Product, Manufacturing, Analytics, Quality, Regulatory, and Supply Chain.
• Track progress, identify risks, resource gaps, and timeline impacts; support mitigation.
• Create updates and reports to communicate progress and decisions to leaders.
• Support budget tracking, spend forecasting, and finance coordination.
• Collaborate with CDMOs and suppliers for timelines and commitments.
• Drive consistency in PM tools, reporting standards and processes.

Skills

Cross-functional

Project management

Communication skills

Strategic partnering

Regulatory knowledge

Education

Bachelor's in Life Sciences

Advanced degree preferred

Tools

Smartsheet

SAP

Ariba

Coupa

Job description

CMC Program Manager/Senior Program Manager

Currently partnered with a global organisation currently expanding their pharmaceutical/small molecule unit and seeking a CMC Project Manager to support a growing portfolio of development programs.

This individual will act as both a strategic and operational partner to CMC leadership, driving integrated project delivery across the lifecycle of development programs from early clinical stages through regulatory submission, launch planning, and commercial readiness. The position focuses on translating scientific and technical strategy into clear, executable cross-functional plans.

Working within a broader Program Management function, this role will collaborate closely with internal stakeholders and external partners to align timelines, manage risks and dependencies, and ensure coordinated execution across all CMC-related activities.

Key Responsibilities

• Contribute to the development and execution of CMC governance frameworks, including meeting structures, reporting cadence, and decision‑making processes.
• Support governance activities by preparing materials, maintaining risk/issue logs, tracking decisions and actions, and ensuring appropriate follow‑up and escalation.
• Build and maintain detailed, integrated project plans covering key milestones, dependencies, critical path activities, and regulatory deliverables.
• Coordinate cross‑functional execution across areas such as Drug Substance, Drug Product, Manufacturing, Analytical Development, Quality, Regulatory, and Supply Chain.
• Track program progress and proactively identify risks, resource gaps, and timeline impacts, supporting mitigation planning where required.
• Develop clear project updates and reporting materials to communicate progress, risks, and key decisions to stakeholders and leadership.
• Support budget tracking activities, including monitoring spend, forecasting, and coordination with finance and functional leads.
• Work with external partners (e.g., CDMOs and suppliers) to ensure alignment on timelines, deliverables, and contractual commitments.
• Help drive consistency in project management tools, reporting standards, and processes to enhance visibility and execution across the portfolio.

Requirements

• Degree in a relevant discipline such as Life Sciences, Chemistry, Engineering, or Business (advanced degree advantageous).
• 5+ years' experience across CMC development and project management within the pharmaceutical/biotech industry.
• Experience supporting small molecule development programs across clinical stages through to submission and pre-commercial activities.
• Proven ability to work cross‑functional across technical and non-technical teams, supporting planning, execution, and decision‑making.
• Strong organisational and communication skills, with the ability to manage complexity and influence without direct authority.
• Experience with project planning tools (e.g., Smartsheet or similar platforms).
• Exposure to regulatory submission activities (e.g., CMC sections of filings)
• Experience managing external manufacturing or development partners.
• Project management certification (e.g., PMP) or equivalent.
• Familiarity with procurement or financial systems (e.g., SAP, Ariba, Coupa, or similar)