CMC Project Leader - Small Molecule Development (m/w/d)

Your mission

Job Summary:
We are seeking a CMC Project Leader with a strong background in small molecule chemistry and development, who combines technical knowledge with regulatory insight and a hands-on, communicative approach. This position is key in driving CMC strategy and execution across development phases — from preclinical to clinical — ensuring alignment with quality standards and global regulatory expectations.

You will coordinate cross-functional CMC efforts including chemistry, formulation, analytical, and manufacturing development, and act as a central interface with regulatory affairs and external partners (CDMOs) with a deep understanding of GxP regulations. Experience in preparing for and supporting CMC regulatory submissions and audits is essential.

Responsibilities:

Lead CMC activities across drug substance (DS) and drug product (DP) development and IMP production for small molecules.
Coordinate e.g. DS related activities and DP formulation development including analytical method development, process development, and tech transfer to manufacturing partners.
Represent CMC in cross-functional project teams and ensure seamless collaboration across internal and external stakeholders.
Drive the preparation and review of CMC sections of regulatory dossiers (e.g., IMPDs, INDs, amendments).
Independently draft and write CMC sections of regulatory dossiers (e.g., IMPDs, INDs), ensuring quality and compliance.
Ensure compliance with ICH guidelines, GxP, and other relevant regulatory requirements.
Support and/or lead CMC audits (regulatory inspections and partner audits), including audit readiness activities and deviation / CAPA management.
Maintain oversight of CMC activities such as timelines, budgets, risks, and deliverables.
Facilitate communication and decision-making across CMC sub-functions and leadership teams.
Support operational oversight of IMP activities during clinical trials in collaboration with Clinical Operations, including label management, temperature excursions, randomization processes, and document review.

Your profile

Requirements / Professional Expertise:

MSc or PhD in Pharmaceutical Sciences, Chemistry, or related discipline.
5–8 years of industry experience in pharmaceutical R&D, with direct involvement in CMC project leadership.
Deep understanding of small molecule development, including API synthesis, formulation, and manufacturing.
Hands-on knowledge of CMC regulatory submissions, ICH guidelines, GxP, quality documentation, and audits/inspections.
Strong organizational and project management skills.
Excellent interpersonal and communication skills with a proactive and collaborative attitude.
Experience at the CMC–Clinical Operations interface, ideally with hands-on involvement in operational oversight of Investigational Medicinal Product (IMP) supply at CDMOs and/or CROs.
Excellent written and verbal communication skills.
Strong organizational and project management skills.
Ability to work independently and as part of a team.
Flexibility to travel domestically and internationally, as required.

Preferred Qualifications:

Experience working with CDMOs in development and GMP manufacturing.
Involvement in Phase I–III development programs.
Ability to work effectively in matrix environments and drive results in lean structures (e.g., biotech/start-up settings).

Why us?

An inspiring work environment in a young, motivated and international team with flat hierarchies.
A permanent position with a competitive salary in an early stage, growing and dynamic company based in Munich.
Multiple learning and development opportunities.
A growing benefit portfolio including a yearly career development budget.
Flexible and family-friendly working hours with the possibility of individual solutions including remote work.
Good connection to public transportation as well as a parking garage in the office building.
We value diversity – regardless of gender, nationality, ethnic and social origin, religion/belief, physical abilities, age as well as sexual orientation and identity.

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About us

HMNC Brain Health (HMNC Holding GmbH) is a precision psychiatry biopharmaceutical company developing personalized treatments for depression based on predictive genetic selection tools. The company’s pipeline includes three Phase 2 programs in Major Depressive Disorder (MDD): Nelivabon, with a vasopressin V1b receptor antagonist guided by a proprietary genetic selection tool; Cortibon, with a CRHR1 antagonist with a matching genetic selection tool; and KET01, a prolonged-release oral ketamine formulation designed for safe, at-home treatment.