Manufacturing Director

**Job Summary**

An experienced and strategic **Manufacturing Director**is responsible to actively work within the Cerecin’s CMC, Manufacturing & Supply Chain department to establish third-party manufacturing sites for active ingredients, finished drug product and placebo, lead the scaling of manufacturing operations as our company transitions from Phase II to Phase III clinical trials. This role will focus on managing the clinical trial material supply chain and overseeing Contract Manufacturing Organizations (CMOs) to produce finished drug products, placebos, and active pharmaceutical ingredients (APIs). Additionally, the Manufacturing Director will identify, recruit, and ensure the qualification of key scale-up production equipment, guaranteeing the successful transition to large-scale production for Phase III trials and beyond, including complex placebo manufacturing and randomization for double-blind trials.

**Key Responsibilities**
- **CMO Management & Oversight**:
Manage relationships with external CMOs for the manufacture of APIs, finished drug products, and placebos. This includes overseeing the selection, qualification, and performance of CMO partners to ensure they meet regulatory, quality, and production timelines. Maintain strong communication with CMOs to ensure timely production and delivery of clinical trial materials.
- **Supply Chain & Clinical Trial Material Management**:
Oversee and manage the production and timely supply of all clinical trial materials (API, finished drug product, placebo) for Phase III clinical trials. Work closely within CMC other functions, such as Formulation & Analytical, quality assurance, and regulatory teams, and clinical operations, to ensure material availability and compliance with GMP and regulatory standards.
- **Scale-Up Production Equipment & Qualification**:
Identify key equipment and technologies needed for the successful scale-up of production processes to support Phase III clinical trials and future commercial needs. Lead efforts to recruit, qualify, and validate production equipment, ensuring it meets operational requirements, regulatory standards, and clinical production capacity demands.
- **Process Scale-Up & Technology Transfer**:
Ensure the successful transfer of technology and manufacturing processes from R&D to large-scale production. Lead the scale-up of production processes for both the drug product, placebo and API, ensuring that the manufacturing methods used in clinical trials are scalable, reproducible, and compliant with regulatory guidelines.
- **Regulatory Compliance & Quality Assurance**:
Ensure all manufacturing operations—both internal and external (CMOs)—comply with relevant regulatory guidelines (e.g., FDA, EMA, TGA) and GMP standards. Oversee the preparation of all necessary documentation for regulatory filings, including CMC (Chemistry, Manufacturing, and Controls) information for Phase III clinical trials,and future NDA filing. Ensure the resolution of any quality issues and compliance gaps.
- **Risk Management & Troubleshooting**:
Identify and mitigate risks associated with scaling up production, including supply chain interruptions, manufacturing delays, and regulatory challenges. Troubleshoot and resolve any production-related issues that arise during the scale-up process or throughout the lifecycle of Phase III trials.
- **Budget & Resource Management**:
Develop and manage budgets for manufacturing activities related to Phase III trials, including CMO engagements, equipment procurement, and scale-up costs. Ensure optimal allocation of resources, both internally and externally, to support manufacturing goals within budget and timeline.
- **Cross-Functional Collaboration**:
Collaborate closely with R&D, Clinical Operations, Regulatory Affairs, Supply Chain, and CMC Quality Assurance teams to ensure alignment and the timely and compliant production of clinical trial materials. Provide updates to senior management on manufacturing progress, challenges, and milestones.

**Qualifications**
- **Education & Experience**:

- A Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field (Master’s degree or Ph.D. preferred).
- At least 10 years of experience in biopharmaceutical manufacturing, with a proven track record in managing the clinical trials materials manufacture and supply
- Strong experience in managing external CMOs for API, finished drug products, and placebo manufacturing.
- Expertise in scale-up production, technology transfer, and qualification of manufacturing equipment for clinical and commercial-scale production.
- In-depth knowledge of GMP, regulatory compliance (FDA, EMA), and industry standards for biologics or complex therapeutics.
- **Skills & Competencies**:

- Strong leadership and team management skills, with the ability to motivate and communicate cross-functional teams.
- Expertise in process scale-up, technology transfer, and troubleshooting in a manufacturing