Planet Pharma

Compensation

Full Description

Title- CMC Project Manager Location- Remote- Must reside in one of the following states: WA, NM, SD, TX, IN, SC, NC, PA, NY, NH, NE, NJ, KY, MA We are seeking a CMC project manager, reporting to the Associate Director, Technical Product Leadership, 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 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. • CDMO Oversight: Manage CDMO performance, ensuring adherence to service and quality agreements, execution of SOWs and organizing performance discussions • Timeline Management: Develop and maintain project timelines, ensuring all milestones are met according to project requirements. • Meeting Coordination: Schedule and facilitate project meetings, including setting agendas, preparing materials, taking accurate meeting minutes, and distributing them to relevant stakeholders. • Communication: Serve as the primary point of contact for project-related communication between internal teams, external vendors, and stakeholders. • Finance Management: Responsible for developing and managing budgets, as well as reviewing and approving vendor invoices to ensure financial accuracy and compliance with organizational policies. • Risk Management: Identify and mitigate project risks, escalating issues as necessary to ensure timely resolution. • Document Management: Maintain accurate and up-to-date project documentation, including project plans, status reports, and other relevant materials. • Performs other duties as assigned QUALIFICATIONS AND EDUCATION • 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 project management • 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 • PMP certification or equivalent is a plus • 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 relationships •