Strategic Leadership:

Develop and execute a robust, phase-appropriate CMC strategy for Juvena’s entire development pipeline, ensuring alignment with corporate objectives, program timelines, and regulatory requirements.

Technical Operations Oversight:

Lead all drug substance (DS) and drug product (DP) activities, including cell line development, process development and optimization, scale-up, and cGMP manufacturing. Provide technical leadership for formulation, fill/finish, drug devices such as pre-filled syringes, and analytical development, including method validation and stability programs.

Oversee internal small scale protein production, engineering, lead optimization, and bioanalytical R&D for discovery and preclinical programs

Cross-Functional Collaboration:

Serve as the CMC subject matter expert on cross-functional program teams across Research, Nonclinical Development, Clinical Development, and Quality Assurance. Work closely with Research and Nonclinical Development to provide protein production and QC leadership to enable robust research activities.

CDMO Management:

Identify, select, and manage a global network of CDMOs and Contract Testing Laboratories (CTLs). Foster strong partnerships to ensure timely execution, high-quality production, and adherence to all regulatory standards for clinical trial material.

Regulatory Strategy & Submissions:

In partnership with Regulatory Affairs, define the CMC regulatory strategy for interactions with global health authorities (e.g., FDA, EMA). Lead the authoring and critical review of all CMC sections for regulatory submissions, including INDs, IMPDs, briefing documents, and future BLAs/MAAs.

Team Leadership & Development:

Build and lead a high-performing CMC organization. Mentor and develop team members, fostering a culture of scientific excellence, accountability, and innovation.

Budget & Timeline Management:

Develop and manage CMC budgets, project timelines, and resources effectively. Proactively identify and mitigate risks to ensure program continuity and success.

Quality & Compliance:

Ensure all CMC-related activities are conducted in strict compliance with current Good Manufacturing Practices (cGMP), ICH guidelines, and relevant global regulatory standards.

Educational Background:

An advanced degree (Ph.D. preferred) in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.

Industry Experience:

A minimum of 15+ years of progressive experience in the biopharmaceutical industry, with extensive experience in the CMC development of biologics (e.g., recombinant proteins, fusion proteins, monoclonal antibodies).

Development Stage Experience:

Proven track record of leading CMC programs from preclinical stages through Phase 2/3 clinical development is required. Late-stage development and commercialization experience is highly desirable. As is familiarity with drug-device combination products.

Outsourcing Expertise:

Demonstrated success in managing a fully outsourced manufacturing model, including the selection, negotiation, and oversight of CDMOs/CTLs.

In-house Protein Manufacturing:

Demonstrated success in managing internal R&D protein production and lead optimization activities

Regulatory Acumen:

Deep knowledge of cGMP, ICH guidelines, and global regulatory expectations. Must have direct experience authoring and reviewing CMC sections of regulatory submissions (INDs, IMPDs) and interacting with regulatory agencies.

Leadership Skills:

Proven ability to build, lead, and mentor a high-performing team. Exceptional leadership, communication, and interpersonal skills, with the ability to influence and align stakeholders across the organization.