Company:  Confidential

Job Title: Sr. CMC Project Manager

Job Number: 78226

Location: Remote, US

Job Description

We are seeking a Sr. CMC Project Manager to join the Technical Operations team at Apogee. This role is responsible for handling all CMC related documentation, managing the internal SharePoint site, and migration of Tech Ops documents to Veeva Quality System, as well as provide Project Management support for one or more CMC Programs. This position requires a self-starter, who can organize projects effectively in a fast-paced setting. If you are interested in utilizing your CMC Project Management expertise to deliver innovative medicine to the patients, enjoy the fast-paced environment and thrive in a culture of growth and camaraderie, this role is for you.  

Responsibilities

* Lead the documentation flow between Tech Ops and our partners (CDMOs, external vendors) and maintain project documentation on SharePoint * Maintain and communicate a current overview of Tech Ops documentation status and issues * Responsible for migration of all relevant Tech Ops documentation into the Veeva Quality System * Work with Tech Ops team members to identify resource constraints, risks, and conflicts that could impact the team’s bandwidth * Provide Project Management support for one or more CMC programs, including building and maintaining the CMC timelines by interfacing with our external partners and facilitating cross-functional collaboration with the Tech Ops * Collaborate closely with the cross-functional Program Management team to ensure integration of Tech Ops activities into overall program plans, monitor project deliverables and ensure tasks are on track * Review and approve vendor accruals and invoices * Assist with tracking outsourced activities as needed

Required Skills

* Bachelor’s degree in science * 10+ years of experience in biotech or pharmaceutical industry with 2 + years of biologics development and manufacturing experience * 3+ years of Technical Operations/CMC experience * Experience working with clinical stage candidates across all phases of Clinical Development (e.g., Ph 1 to Ph 3) * Experience with Process Characterization and PPQ a plus * Good technical knowledge of CMC development, CMC Regulatory Affairs, Quality, GMP requirements * Extensive knowledge of Smartsheet and Microsoft Project * Veeva experience is highly desired * Assertive and proactive * Highly organized with meticulous attention to detail * Ability to multi-task and keep pace with a fast-moving organization * Ability to participate in calls across multiple international time zones * Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless * Ability and willingness to travel up to 15% to company All Hands Meetings, and the Apogee lab in BostonThe anticipated salary range for candidates for this role will be $150,000 to $170,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

Application Deadline: 2024-06-03

 

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