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Mariana Oncology · 1 day ago

Senior Project Manager, CMC Operations

Watertown, MA

Full-time

Onsite

Mid, Senior Level

$113K/yr - $157K/yr

3+ years exp

Mariana Oncology is advancing personalized medicine and radiopharmaceuticals, and they are seeking an experienced Project Manager or Senior Project Manager for their CMC Operations team. This role will involve managing project deliverables, ensuring collaboration across teams, and overseeing the execution of CMC project activities.

BioinformaticsBiometricsBiopharmaBiotechnologyOncology

Responsibilities

Manage end-to-end planning, coordination, and execution of radiochemistry team activities supporting preclinical studies in collaboration with scientists, CROs/CMOs, and internal stakeholders

Track and monitor key CMC deliverables across multiple programs at different stages of development to ensure on-time and high-quality outputs

Review, track, and manage electronic laboratory notebook (ELN) entries to ensure accuracy, compliance, and timely closure

Centralize and manage all applicable studies, including but not limited to space planning, working with appropriate stakeholders for ordering and delivery of isotopes, other raw materials, and all other physical components necessary for successful study completion, and overall program delivery optimization

Oversee preparation, review, formatting, and completion of technical reports, ensuring consistency, accuracy, and timely approval

Capture and disseminate clear, concise project information, meeting minutes, and activity updates to appropriate stakeholders

Adhere to and be the standard bearer for all necessary and appropriate regulatory requirements

Interface with cross-functional project managers and project leaders to align radiochemistry deliverables with broader program milestones and corporate objectives

Work with Finance team to maintain appropriate budgets and communicate monetary impacts of CMC activities

Assess, communicate, and mitigate risks as necessary

Identify opportunities to improve workflows within the CMC radiochemistry team

Qualification

Radiochemistry experienceGMP development knowledgeProject managementRadiopharmaceuticals experienceCMC documentation understandingSoftware tools expertiseTeam communicationData integrity commitmentRisk assessmentTime managementWritten communicationOral communication

Required

Bachelor's degree in a relevant scientific discipline with 3 – 5+ years' industry experience in project/program management, operations, and/or radiochemistry roles

Experience within radiopharmaceuticals, preclinical development, and/or CMC environments is required

Strong understanding of non-GMP and/or GMP development activities, preferably within preclinical and/or early clinical environments, is required

Excellent grasp of fundamental project management skills, including but not limited to organization, time management, matrixed management, and effective team communication is required

Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements

Strong written and oral communication skills is required

Preferred

Good understanding of the radiation safety regulations and guidelines is preferred

Understanding of chemistry manufacturing and controls (CMC) documentation for novel compounds consistent with requirements for IND regulatory pathways and other global regulatory standards is preferred

Expert knowledge of software tools and workflows to enable an efficient and scalable project execution process

Experience managing CROs/CDMOs and other product or service vendors is preferred