Senior Project Coordinator

1 day ago


Oakland, California, United States Enigma Search Full time
Job Description
We are searching for a highly skilled Senior CMC Program Manager to join our team at Enigma Search. As a key member of our organization, you will be responsible for leading complex programs across the CMC lifecycle, coordinating cross-functional teams, and managing client relationships. If you have a passion for driving success and delivering results, we encourage you to apply.

About the Position
This role requires a strong understanding of CMC operations and workflows within GMP environments. You will oversee tech transfers, ensure readiness across development and manufacturing functions, and manage workflows to transition projects seamlessly from development to GMP manufacturing. Additionally, you will ensure process and assay development meet scalability and quality standards.

Key Responsibilities
- Lead full lifecycle CMC programs, from planning to execution and delivery of milestones, such as GMP readiness and regulatory submissions.
- Coordinate cross-functional efforts across Process Development (PD), Analytical Development (AD), Manufacturing Sciences and Technology (MSAT), Quality Control (QC), and Manufacturing (MFG).
- Act as the primary client liaison, defining scopes, timelines, KPIs, and pathways for issue resolution.

Qualifications
- Bachelor's degree in Life Sciences, Engineering, or a related field.
- 3-5+ years of project or program management experience in biotech, pharma, or cell and gene therapy.
- Proven experience managing CMC lifecycle projects involving PD, AD, MSAT, MFG, and QC.
- Familiarity with regulatory submissions (IND, IMPD, BLA) and compliance.
- Experience working with sponsor drug development or CDMOs preferred.
- PMP certification strongly preferred.

What We Offer
- Competitive salary: $120,000 - $180,000 per annum.
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.

How to Apply
- Proficiency with project management tools like Smartsheet and ThinkCell.
- Strong communication, negotiation, and client management skills.

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