This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted.

We are seeking an experienced Associate Director PM - CMSC to support cross-functional teams responsible for executing manufacturing and supply chain strategies for late-stage development and commercialization of biologics or similar therapeutic products. This role involves close collaboration with internal technical leaders, program management, and external manufacturing partners to drive project execution, ensure alignment with key milestones, and support successful product launches.

The ideal candidate will have a strong background in biologics or pharmaceutical development, a solid understanding of GMP operations, and demonstrated expertise in project management. This individual should be highly detail-oriented, adaptable to shifting priorities, and able to work effectively in a matrixed, fast-paced environment.

Key Responsibilities:

• Lead the planning and execution of late-stage development, manufacturing, validation, and commercialization efforts for assigned product workstreams.

• Collaborate with internal stakeholders and external partners to define project scope, timelines, milestones, and deliverables.

• Develop and maintain project plans covering manufacturing, validation, testing, regulatory submissions, and launch readiness.

• Identify critical path activities and manage interdependencies across functions and vendors.

• Facilitate team meetings and ensure alignment across all contributors and stakeholders.

• Monitor project status, key decisions, risks, and mitigation plans, ensuring timely communication and issue resolution.

• Maintain transparent and proactive communication across cross-functional teams and leadership.

• Organize team documents, including meeting agendas, minutes, decision logs, action trackers, and risk registers.

• Support the implementation of project management tools and templates to track and report project progress.

• Ensure compliance with standard operating procedures and applicable regulatory or quality requirements (GxP).

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or a related field (Advanced degree or PMP certification preferred).

• Minimum 8 years of experience in the biopharmaceutical, biotechnology, or life sciences industry.

• At least 5 years of project management experience supporting manufacturing, supply chain, or technical development projects.

• Strong knowledge of GMP regulations and the drug development lifecycle, including process validation and commercialization.

• Experience working with external manufacturing or service partners.

• Proficiency with Microsoft Office (Excel, Word, PowerPoint, Outlook) and project management software (e.g., MS Project, Smartsheet).

• Strong communication, facilitation, and organizational skills with the ability to clearly present complex topics to cross-functional teams and leadership.

• Analytical mindset with a balance of detail orientation and strategic perspective.

• Experience with regulatory filings, manufacturing operations, or quality assurance/control is a plus.