CMC Program Manager, Biopharma Tech Ops

Kiniksa Pharmaceuticals; Lexington (MA); On-site; USD 145,000 - 150,000; Full time

Job summary

Kiniksa Pharmaceuticals seeks a CMC Project Manager to join our Lexington, MA team, onsite five days a week. You will partner with cross-functional teams to manage complex CMC activities for one or more products, and support budget forecasting and management.

The role emphasizes CDMO relations, external tech transfers, and planning across development, manufacturing, and regulatory activities, with a focus on timely, on-budget execution.

Qualifications

• Bachelor's Degree in Science, Engineering or related field with 2-5 years relevant biopharmaceutical industry experience
• At least 1 year of project management experience as either a designated project manager or PM responsibilities as part of a technical role
• Working knowledge of large (preferred) and/or small molecule process development and GMP manufacturing
• Prior experience working with CDMOs and managing external tech transfers
• Working knowledge of project management tools and techniques
• Informed on current biopharmaceutical industry requirements, news and trends
• Independent, motivated, team member with experience in a matrix environment
• Strong business acumen
• Ability to foster effective relationships and collaboration, motivate others, influence without authority
• Ability to accommodate flexible working hours to support business relationships in different time zones
• Some domestic and international travel may be required

Responsibilities

• Support development and management integrated project plans for one or more products
• Partner with technical project leaders to coordinate project meetings, communicate progress, and prioritize activities
• Manage relationships with CDMOs to enable successful outcomes and on-time/on-budget development and manufacturing activities
• Prepare clear communication documents such as meeting minutes and registers capturing decisions, actions, risks, and assumptions
• Assist with routine project health assessments including maintenance of risk registry, risk identification, mitigation development, and communication/escalation to key stakeholders as appropriate
• Support project team preparation for governance meetings
• Oversee day to day contract activities with external vendors from scope development through progress tracking, accruals, and invoicing
• Support budget development and long-range forecasting

Skills

Project management

Cross-functional collaboration

Budget forecasting

Communication

Travel flexibility

Strategic thinking

Education

Bachelor's degree

Job description

Kiniksa Pharmaceuticals seeks a CMC Project Manager to join our Lexington, MA team, onsite five days a week. You will partner with cross-functional teams to manage complex CMC activities for one or more products, and support budget forecasting and management.

The role emphasizes CDMO relations, external tech transfers, and planning across development, manufacturing, and regulatory activities, with a focus on timely, on-budget execution.