Director of Manufacturing
The Manufacturing Director holds a pivotal position in supervising and enhancing manufacturing procedures for medical and biotech products, ensuring that resources, equipment, and facilities are aligned to meet production demands for business support.
This role involves ensuring compliance with all cGMP and ISO standards, maintaining sufficient product availability, and optimizing the effectiveness and efficiency of the production process.
The Director effectively communicates and collaborates across Quality Assurance, Research and Development, Purchasing, Sales and Marketing, Executive Management, and external contract manufacturers.
Responsibilities And Duties
- Develop & execute plans and resource requirements to ensure fulfillment of required production per business needs
- Provide oversight of the production process and ensure adequacy for proper regulatory reporting and / or product recalls
- Keep management and quality staff informed of all issues that could interrupt or affect production flow
- Develop & adhere to departmental budget Identify, implement & utilize MRP systems to plan & manage production activities
- Implement efficiency improvements & cost reduction efforts consistent with corporate goals
- Proficient use of manufacturing software systems such as MRP, MES, SPC, and Compliance tools
- Ensure compliance to all applicable FDA, ISO, Quality System, safety requirements
- Utilize statistical methods and data analysis tools to identify trends, deviations & opportunities for optimization / improvement
Qualifications :
- Bachelor's degree in chemistry, biochemistry, or a related field (Master's or PhD preferred)
- 10+ years of experience in manufacturing for BioTech / Chemistry
- Strong familiarity with FDA regulations (e.g., 21 CFR 820) and ISO standards (e.g., ISO 13485)
- Extensive expertise in manufacturing principles, processes, and technologies, including Lean Manufacturing, Six Sigma, and Continuous Improvement methodologies
- Lean or Six Sigma certification is advantageous
- Proficiency in Design Control
- 5-10 years of experience in leadership roles (e.g., manager, director)
- Experience in process validation and statistical process control
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