Job Description

Senior Manager/Director, Project Management CMC

About Us:

is a clinical-stage biopharmaceutical company focused on the development and commercialization of transformational therapies for high unmet medical needs. Timberlyne’s lead program is CM313, an IgG1 monoclonal antibody with enhanced complement-dependent cytotoxicity that targets CD38. By targeting CD38, which is highly expressed on plasma cells, NK cells, and other immune cells, CM313 modulates multiple immune cell types leading to both rapid and durable responses across a range of autoimmune diseases and cancers.

Position Summary:

Timberlyne is seeking a Project Manager, CMC responsible for successful delivery of large scale, complex CMC projects, and programs with senior-level internal and/or external stakeholders and vendors within approved budget, schedule, scope, and quality standards. This person will be responsible for overseeing project delivery resources to ensure the use of standardized project management methodologies, processes, and tools. They will provide leadership and direction, and serve as an expert resource, manage the daily activities of assigned projects, identify potential issues, evaluate solutions, and make recommendations. Assess change requests to determine project impacts, report overall program status to key project leadership and implement communication plans. The responsibilities are including but not limited to the following:

Essential Functions:

• Work with the CMC Development and Operations teams to ensure that CDMOs and CROs fulfill proposal/contract requirements and complete process development or manufacturing projects as appropriate.
• Apply PM best practices to monitor and track the progress of projects, including but not limited to preparing minutes, actions, decision, and issues/risk logs.
• Coordinate and communicate project activities and information flow both internally within Timberlyne and externally with CDMOs and CROs.
• Manage scope changes during project execution.
• Coordinate regular internal project meetings to discuss and plan projects.
• Participate in regular meetings with contract organizations to update progress via teleconference or site visits as appropriate.
• Maintain accurate records to document all relevant communications related to projects.
• Support the maintenance of high-quality templates and communication formats and overall harmonization and organization of documentation within the function.
• Monitor timelines and contracts for accuracy and follow up on any discrepancies with third-party networks and/or internal personnel.
• Support CMC activities by tracking and maintaining development and manufacturing documentation.
• Manage the transfer of data and records from contract manufacturing organizations.
• Coordinate with legal, technical, and development teams to establish nondisclosure agreements, service terms and conditions, and quality agreements as appropriate.
• Review and facilitate the approval of proposals, work orders, and changes in a timely manner.
• Facilitate lessons learned reviews after projects to identify opportunities for improvement.
• Collaborate with cross-functional team members across the organization to drive projects effectively and efficiently to completion.
• Foster a team culture of collaboration, ownership and accountability.
• Performs other duties as required.

Skills and Experience:

• Bachelors or MS degree (or higher) in Life Sciences, Pharmaceutical Sciences, Chemical Engineering or Chemistry preferred
• 5+ years of hands-on experience in large molecule drug product development within the pharmaceutical / biotech industry
• Experience with CMC Project/Portfolio management
• Familiarity with US and international regulatory CMC guidance and processes
• Strong understanding of ICH guidance and cGMP regulations and manufacturing
• Working knowledge of quality by design and risk management is strongly desired.
• Strong organizational skills with attention to detail and ability to manage multiple projects at once
• Ability to work both independently and in a team focused environment
• Experience leading and/or working with cross-functional teams with the ability to negotiate, influence, and drive change
• Strong oral and written communication skills
• Experience with project management tools: Smartsheet, MS Project, Excel (or similar programs)
• Advanced proficiency in Microsoft Office Suite (Word, PowerPoint, Outlook, Teams)

How To Apply : Please send your resume to [email protected]

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity/expression, national origin, disability, medical condition, age, marital status, status as a protected veteran, or any other legally protected characteristic.

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