CMC Project Manager

Reporting to the Sr. Director Tech Ops Business Operations, this individual will serve as an integral member of technical process development, analytical, manufacturing and supply chain teams at Kiniksa Pharmaceuticals. This person will partner with team and technical leads to manage complex CMC activities for one or more products, analyze product development scenarios, and play a key role in budget forecasting and management. This cross-functional position requires a solid understanding of the functional operations involved in Chemistry, Manufacturing, and Controls for biologics including (but not limited to) drug substance, drug product, analytical development and quality control. Direct experience managing technical transfers is a must. The ideal candidate will also be proficient in the planning and integration of combination product, supply chain, and regulatory activities.

The CMC project manager will support technical teams and manage associated projects both in-house and at external development, testing, and manufacturing organizations. Ability to work some flexible hours is a must to manage activities and interactions with global partners.

This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Responsibilities (including, but not limited to):

• 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
• Participate in scenario development and strategic planning
• Support budget development and long-range forecasting

Standout Skills for Impact:

• Prior experience working with CDMOs and managing external tech transfers

Qualifications and Experience:

• Requires a Bachelor's Degree in Science, Engineering or a related field with at least 2-5 years relevant biopharmaceutical industry experience
• A minimum of 1 year of project management experience as either a designated project manager or PM responsibilities as part of a technical role
• Strong written/oral communication skills
• 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