Senior Project Manager, CMC Operations

Mariana Oncology • Watertown, MA

1d • $113,050 - $157,335

About The Position

We are seeking an experienced Project Manager or Senior Project Manager, CMC Operations to join Mariana’s Chemistry, Manufacturing & Controls organization, advancing personalized medicine and radiopharmaceuticals. This person will be a key interface between and within project teams for the CMC and adjacent teams to effectively collaborate, plan, and execute projects for a robust and complex asset portfolio. With the guidance of the Head of Radiochemistry, s/he will be responsible for shepherding timely and coordinated execution of CMC project deliverables.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• US-based eligible employees will receive a comprehensive benefits package that includes a strong health insurance package, life insurance, disability benefits, a 401(k) with company contribution and match, tuition reimbursement, and a variety of other benefits.
• In addition, employees are eligible for a generous flexible time off program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees