CMC Consultant/ Junior Project Manager

Startup Atlas; Town of Belgium (WI); Hybrid; USD 25,000 - 45,000; Part time

Job summary

Startup Atlas is seeking a part-time CMC Consultant / Junior Project Manager to support development activities in a fast-growing biotech environment. You will blend scientific oversight with operational coordination, interfacing with CROs/CMOs, and contributing to regulatory CMC documentation for DS/DP programs.

You will work closely with internal teams and external partners to ensure timely, compliant advancement of development programs in a GMP-aligned setting, with emphasis on analytical

Qualifications

• 1–2 years of experience in CMC development, biotech, or pharmaceutical project management.
• Experience with biologics and/or complex CMC programs is a strong asset.
• Familiarity with analytical method validation (ICH Q2/Q14) is advantageous.
• Fluent in French and excellent command of English (written and spoken).

Responsibilities

• Track and coordinate CMC activities for Drug Substance and Drug Product.
• Interface with CROs/CMOs to meet quality and timeline expectations.
• Support analytical method qualification and validation activities.
• Prepare CMC documentation and regulatory submissions (IND/IMPD).
• Monitor subcontractor tasks and budgets; provide progress updates.

Skills

French

English

Job description

Delivering breakthrough therapies for stroke patients by developing an innovative pipeline in thrombo-inflammation.

We are seeking a part-time CMC Consultant / Junior Project Manager to support the execution and coordination of development activities within a fast-growing biotech environment. This position combines scientific oversight and operational project coordination, with direct exposure to Drug Substance (DS) and Drug Product (DP) development, analytical method validation, and regulatory CMC documentation.

Job Description

Role Overview

We are seeking a part-time CMC Consultant / Junior Project Manager to support the execution and coordination of development activities within a fast-growing biotech environment. This position combines scientific oversight and operational project coordination, with direct exposure to Drug Substance (DS) and Drug Product (DP) development, analytical method validation, and regulatory CMC documentation. The consultant will work closely with internal stakeholders and external partners (CROs, CMOs) to ensure timely, compliant and high-quality advancement of development programs in a GMP-aligned setting.

Responsibilities/tasks

CMC & technical oversight

• Track and coordinate CMC activities related to Drug Substance and Drug Product manufacturing.
• Interface with and monitor external vendors (CROs, CMOs), ensuring deliverables meet quality and timeline expectations.
• Support analytical method qualification and validation activities.
• Perform critical review of analytical and CMC documentation.
• Contribute to vendor selection and performance evaluation.

Regulatory & Documentation

• Draft, review and maintain CMC documentation.
• Contribute to CMC sections of regulatory submissions (IMPD, IND).
• Support preparation and follow-up of stability protocols and reports.

Project Management & Coordination

• Monitor subcontractor tasks, deliverables, and associated budgets.
• Prepare structured progress updates for internal teams.
• Ensure proper documentation management and archiving in compliance with GxP requirements.
• Minimum 1-2 years of experience in CMC development, pharmaceutical development, or biotech project management.
• Experience in working with biologics and/or complex CMC programs is a strong asset.
• Familiarity with analytical method validation (ICH Q2/Q14) is advantageous.
• Knowledge of GMP and general GxP expectations.
• Strong organizational skills with the ability to prioritize in a dynamic environment.
• Comfortable operating in a fast-growing biotech company with challenging timelines.
• Analytical mindset, proactive problem-solving approach, and strong ownership.
• Fluent in French and excellent command of English (written and spoken).