Sr. Project Manager/Project Manager, CMC (Contract)

Title: Sr. Project Manager/Project Manager-CMC (Contract)

Location: Boston, MA

Duration: 6 months 

Pay: $75/hr-$80/hr

Job Summary:

We are seeking a CMC Project Manager to join our dynamic team and play a key role in managing our Chemistry, Manufacturing, and Controls (CMC) projects covering chemical development (drug substance), formulation development (drug product), analytical development (drug substance and drug product) and packaging and labeling (finished product).  The role will operate within a 100% outsourced business model with the incumbent being accountable for team deliverables ensuring operational excellence with respect to timelines, budgets, and attainment of technical, regulatory, and business goals/milestones. This is an exciting opportunity to contribute to the development of novel cancer treatments and make a meaningful impact on patient outcomes.

Responsibilities:

• Develop and maintain project CMC project plans, incorporating activities, internal/external requirements, and key interdependencies to deliver tangible results against program and corporate goals.
• Direct and coordinate multiple projects to ensure on-time and on-budget delivery.
• Provide team meeting management including meeting agenda, action plans, and thorough follow-up.
• Maintain financial accountability for assigned projects ensuring budgets are established, executed to, and change controls managed appropriately.
• Organize and plan project tasks and schedules utilizing industry standard tools such as MS-Project, Timeline Pro+ and Monday.com.
• Identify, define, prioritize, and communicate risks to successful project execution; develop and monitor risk mitigation and contingency plans.
• Manage tasks in accordance with Project Management Institute (PMI) standards and those of the company.
• Communicate project status to stakeholders and key project participants.
• Support development and implementation of PM systems and best practices to ensure consistency and operational effectiveness within and across functions and programs.
• Support the management of external suppliers, including contract manufacturing and development organizations (CDMOs), to ensure timely and high-quality delivery of CMC-related activities.
• Create presentations, dashboards, and reports to communicate project status, key internal metrics, and/or risk mitigations.
• Identify opportunities for process optimization, standardization, and implementation of best practices within the CMC project management function.
• Collaborate closely with internal teams to ensure effective and timely cross-functional communication and decision-making to support successful execution of project plans.
• Ensure CMC projects adhere to regulatory guidelines, industry standards, and Good Manufacturing Practices (GMP), collaborating with Regulatory Affairs to prepare documentation for regulatory submissions.

Professional Experience/Qualifications:

• Bachelor's or advanced degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences) or a related field.
• Minimum of 5+ years of experience in R&D and/or drug development project management or cross functional team leadership experience in pharmaceutical industry.
• Self-directed, accomplishment-driven individual with a strong sense of passion and urgency who can work independently and in a cross-functional team environment.
• Proven track record of successfully managing complex projects, including planning, execution, and resource management, while meeting deadlines and budgetary requirements.
• Direct experience of interactions with CDMOs and manufacturing operations.
• Proven success working in cross-functional teams.
• Strong understanding of productivity tools such as Microsoft Project, PowerPoint, Excel, Word and other related software
• Familiarity with regulatory requirements and guidelines governing CMC aspects of drug development, such as FDA, EMA, and ICH guidelines.
• Excellent verbal and written communication skills, with the ability to effectively convey complex scientific and technical information to diverse audiences.
• Demonstrated leadership and team management skills, with the ability to motivate and inspire cross-functional teams to achieve project objectives.
• Strong problem-solving and analytical skills, with the ability to identify potential risks, propose solutions, and make data-driven decisions.
• Meticulous attention to detail, ensuring accuracy and quality in project documentation and deliverables.
• Ability to thrive in a fast-paced and rapidly changing environment, managing multiple priorities effectively.
• Commitment to maintaining compliance with relevant regulations, guidelines, and best practices.
• Experience in oncology drug development is desirable.