CMC Program Lead

Asgard Therapeutics AB; Mississippi; Hybrid; USD 90,000 - 150,000; Full time

Job summary

An innovative biotech firm is seeking a CMC Program Lead to oversee Chemistry, Manufacturing, and Controls across the drug development lifecycle. This pivotal role involves strategic planning, regulatory compliance, and collaboration with cross-functional teams to ensure successful project execution. The ideal candidate will have extensive experience in the pharmaceutical industry, particularly in CMC project management, and possess strong leadership and communication skills. Join a forward-thinking company where you can make a significant impact on groundbreaking therapies and contribute to transforming cancer treatment through cutting-edge technology.

Qualifications

• 8+ years in pharmaceutical/biotech industry focusing on CMC project management.
• In-depth understanding of CMC processes for drug development.

Responsibilities

• Lead CMC programs from research through clinical stages to commercialization.
• Collaborate with internal and external teams to execute CMC strategies.

Skills

Project Management

Communication Skills

Problem-Solving Skills

Organizational Skills

Leadership

Education

Bachelor’s degree in Life Sciences

Advanced degree (MS/PhD)

Tools

GMP

Regulatory Requirements

Job description

Asgard Therapeutics is a privately held biotech company pioneering in vivo direct cell reprogramming for cancer immunotherapy, backed by Johnson & Johnson Innovation – JJDC, Inc., RV Invest, Novo Holdings, Boehringer Ingelheim Venture Fund, and Industrifonden. Our lead candidate, AT-108, is a first-in-class gene therapy that reprograms tumor cells into antigen-presenting dendritic cells (cDC1), triggering a personalized and potent anti-tumor immune response.

Position Overview

The CMC Program Lead will oversee Chemistry, Manufacturing, and Controls (CMC) across the drug development lifecycle – from early development through to commercialization. This includes planning and coordinating drug substance and drug product development, regulatory filings, and supply chain management. The role requires close collaboration with internal teams and external partners to ensure timely, compliant, and successful project execution.

Key Responsibilities

1. Lead strategic planning of CMC programs from research through clinical stages to commercialization.
2. Develop and present project plans, status updates, and strategies to senior management and stakeholders.
3. Identify and manage CMC-related risks, implementing corrective actions to maintain timelines and resources.
4. Collaborate with internal and external team members (Technology, Manufacturing, Regulatory Affairs, R&D, Quality) and partners (e.g., CMOs) to execute and align CMC strategies.
5. Prepare for and contribute to CMC-related regulatory submissions (e.g., CTA, IND, BLA) to support clinical trials.
6. Foster relationships with external partners, vendors, and consultants to ensure regulatory compliance.
7. Ensure effective communication between stakeholders, tracking progress, and timely project delivery.
8. Stay informed of industry trends, technological advancements, and regulatory changes to continuously inform project decisions.
9. Play a significant role in developing the CMC function within the company.

Supervisory Responsibilities

1. Lead cross-functional sub-teams, identifying and resolving complex issues to achieve project goals.
2. Mentor and support to junior team members and colleagues involved in CMC activities.

Required Qualifications & Skills

1. Education: Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field; Advanced degree (MS/PhD) in a scientific discipline or business is preferred.
2. Experience: Minimum of 8+ years in the pharmaceutical/biotech industry, with a focus on CMC project management, drug development, and manufacturing in a regulated environment. Knowledge of cell therapy or gene therapy is a bonus.
3. Industry Knowledge: In-depth understanding of CMC processes for drug development, including biological and/or cell therapy products.
4. Regulatory Knowledge: Experience in authoring CMC sections for CTA, IND, or similar regulatory submissions (NDA or MAA knowledge is a plus).
5. Leadership: Proven ability to lead cross-functional teams, manage stakeholders, and drive complex projects.
6. Skills: Strong communication, organizational, and problem-solving skills. Ability to work in a fast-paced environment and adapt to changing priorities.
7. Technical Expertise: Knowledge of GMP, regulatory requirements, biopharmaceutical development, manufacturing and control. Understanding of viral, mRNA, lipid-based products and formulations, and cell therapy technologies is a plus.

Location: Remote (with 4-5 days per month on-site at company or third-party facilities such as CDMOs).

Reports to: Chief Development Officer (with dotted line supervision by Head of CMC).

Application

Please email your CV, cover letter and contact information for two references to [e-mail]. Asgard reviews applications on a rolling basis and only shortlisted candidates will be contacted.