Job Description

Job Title: CMC Project Manager (Contract)

Location: Hybrid (2–3 days onsite per week)

Position Summary

The CMC Project Manager will be responsible for managing project plans and timelines for Chemistry, Manufacturing, and Controls (CMC) activities that support the life cycle management of commercial programs. This role requires collaboration across regulatory, manufacturing, quality, supply chain, and process sciences functions to ensure successful execution of technical operations and quality initiatives.

Key Responsibilities

• Manage project plans and timelines for CMC activities supporting commercial and development programs.
• Collaborate with CMC leads and cross-functional stakeholders to establish and update project plans, including risk mitigation strategies.
• Support early-stage programs by maintaining and updating CMC templates in Smartsheet to align with process changes.
• Partner with CMC project managers and leads to improve project plans, resource allocation, and risk management.
• Prepare and deliver presentations on project updates and improvements to the CMC PM team.

Qualifications

• Bachelor’s degree required; Life Sciences or Engineering strongly preferred.
• 3–5 years of development and/or project management experience in the pharmaceutical or biopharmaceutical industry.
• Familiarity with CMC development stages (early phase I/II clinical trials and late-stage/commercial) preferred.
• Proficiency with MS Office Suite (Excel, Word, PowerPoint) and Smartsheet.
• Strong organizational, time management, and project management skills.
• Excellent communication and interpersonal abilities.
• Ability to work independently as well as collaboratively within cross-functional teams.

Ideal Candidate Profile

Top 3 Must-Haves:

• Proven project management experience.
• Strong communication skills with ability to engage across all levels.
• Ability to multitask and balance independent and team-based work.

Nice-to-Haves:

• Experience with early- or late-stage development.
• Familiarity with evolving process documentation and templates.

Soft Skills:

• Highly organized and detail-oriented.
• Proactive communicator.
• Adaptable to changes in systems and processes.

Day-to-Day Responsibilities

• Regularly update and maintain project timelines.
• Follow up on missing information to ensure timely updates.
• Utilize Smartsheet to manage templates and adapt them to evolving processes.

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