CMC Program Manager I — Client-Facing (Remote)

BioSpace

Boston (MA)

Hybrid

USD 110,000 - 170,000

Full time

3 hours ago

Be an early applicant

Application generator

Turn this role into an interview — a resume and cover letter built around what this employer wants.

Get past ATS filters

Benefits offered by this job

Remote work options

Office locations in Greater Boston

Job summary

Syner-G BioPharma Group is seeking a Consultant I to drive CMC program execution across drug substance, product, analytical, quality, and regulatory workstreams. You will coordinate cross-functional teams, vendors, and client stakeholders to ensure on-time delivery from development through commercialization.

Travel to client sites may be required up to 100%, with opportunities to work with CDMOs, CMOs, and labs.

Qualifications

Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline required.
Advanced degree preferred.
Experience managing cross-functional CMC development programs within biotechnology, pharmaceutical, CDMO, or consulting organizations.
Proficiency with project management tools and software, including Microsoft Project and related planning and reporting applications.

Responsibilities

Develop and manage integrated CMC project plans and timelines across drug substance, drug product, analytical, quality, and regulatory workstreams.
Coordinate end-to-end clinical supplies operations, including demand forecasting, manufacturing scheduling, packaging, labeling, release, distribution planning, and inventory management.
Oversee packaging and labeling activities for investigational products, ensuring GMP compliance and regulatory requirements.
Prepare and communicate project status reports, dashboards, and milestone reviews for clients and internal stakeholders.