CMC Project Manager

Remote CMC Project Manager needed!

PLEASE DO NOT APPLY IF YOU DO NOT ALREADY RESIDE IN THE FOLLOWING STATES: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY or WA.

Summary:

We are seeking a CMC project manager, reporting to the Executive Director, Head of Program Management, to support our CDMO and clinical trial activities. If you are a highly motivated and experienced CMC project management professional passionate about developing innovative cell therapies, we encourage you to apply for this exciting opportunity to join our team.

Key Responsibilities:

• Serve as the day-to-day liaison between internal teams and CDMO partner, coordinating project timelines, deliverables, and communications
• Manage CDMO performance, ensuring adherence to service and quality agreements and effective execution of SOWs
• Develop and maintain project timelines, ensuring all milestones are met according to project requirements.
• Schedule and facilitate project meetings, including setting agendas, preparing materials, taking accurate meeting minutes, and distributing them to relevant stakeholders.
• Serve as the primary point of contact for project-related communication between internal teams, external vendors, and stakeholders.
• Support financial tracking for CDMO projects, including creation and management of SOWs, purchase orders, and change orders to ensure alignment with project scope and timelines
• Identify project risks and escalating issues as necessary to ensure timely resolution.
• Maintain accurate and up-to-date project documentation, including project plans, status reports, and other relevant materials.

Qualifications & Education:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor's degree in a related field (e.g., Project Management, Engineering, Life Sciences) or equivalent experience
• 5+ years of experience in a pharmaceutical or biotechnology setting with 3+ years of CMC or external manufacturing project management, direct exposure to cell or gene therapy programs, preferred
• Must have held a CMC PM title is required
• Strong organizational and time management skills, with the ability to prioritize tasks effectively
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
• Proficiency in Microsoft Office Suite, SharePoint, and Smartsheet
• Knowledge of regulatory requirements related to pharmaceutical or biotechnology projects is preferred

Required Skills & Abilities:

• Able to and comfortable with travel up to 25%
• Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met
• Must have strong attention to detail and demonstrated decision making ability
• Ability to work individually and in a team environment
• Demonstrated excellence in written and verbal communication skills
• Strong collaboration and demonstrated ability to work cross-functionally at all levels of the organization to drive strong business partner relationship