Biosimilar Sciences PR LLC is hiring: Manager of Parenteral Manufacturing in 006

About OcyonBio:
OcyonBio is a dynamic and innovative startup specializing in cutting-edge biopharmaceutical manufacturing. We are committed to revolutionizing the parenteral drug development landscape by offering flexible, scalable, and high-quality solutions. As we grow, we are seeking passionate and experienced individuals to join our team and contribute to the development of life-saving therapies.

Position Summary:
The Manager of Parenteral Manufacturing will be responsible for leading and overseeing the manufacturing operations of parenteral products at OcyonBio. This individual will ensure that all manufacturing activities are compliant with regulatory standards and internal SOPs while driving continuous improvements in efficiency, quality, and safety. The Manager will collaborate cross-functionally with Quality Assurance, Process Development, Engineering, and Supply Chain to ensure the successful production of high-quality parenteral products.

Key Responsibilities:

• Lead day-to-day operations of the parenteral manufacturing department, including the preparation, formulation, filling, and packaging of injectable drug products.
• Ensure compliance with FDA, cGMP, and other regulatory requirements for sterile manufacturing.
• Develop, implement, and maintain standard operating procedures (SOPs) and best practices for manufacturing processes.
• Collaborate with cross-functional teams to support technology transfer and scale-up of parenteral products from development to commercial manufacturing.
• Manage and mentor a team of manufacturing associates and supervisors, providing leadership and guidance to foster a high-performance culture.
• Drive continuous improvement initiatives to optimize manufacturing processes, reduce costs, and improve operational efficiency.
• Ensure timely completion of production schedules while maintaining high-quality standards.
• Oversee equipment qualification, validation, and maintenance to ensure optimal performance and compliance with regulatory standards.
• Collaborate with the Quality Assurance team to investigate deviations, implement corrective actions, and ensure product quality.
• Monitor and report on key performance indicators (KPIs) related to manufacturing efficiency, product quality, and safety.

Qualifications:

• Bachelor’s degree in Engineering, Biochemistry, Pharmaceutical Sciences, or a related field. Advanced degree preferred.
• A minimum of 5-7 years of experience in parenteral manufacturing, with at least 3 years in a leadership or management role.
• In-depth knowledge of cGMP, FDA regulations, and aseptic processing techniques.
• Proven experience in the scale-up and commercial manufacturing of injectable products.
• Strong leadership and team management skills, with the ability to inspire and develop staff.
• Excellent problem-solving, organizational, and communication skills.
• Ability to work in a fast-paced, startup environment and adapt to changing priorities.
• Experience with process validation, equipment qualification, and regulatory audits.