MSAT Director – Permanent – Texas, US
Are you ready to lead cutting‑edge MSAT and accelerate breakthroughs in biotech? Proclinical seeks a Director of MSAT to join a dynamic team and play a pivotal part in advancing and optimizing biotechnology processes.
Key Responsibilities
- Ensure the safe and efficient production of transformative medicines.
- Collaborate with cross‑functional teams to support process transfers, scale‑up, improvements, and troubleshooting.
- Design and execute experiments to evaluate and optimize manufacturing processes.
- Develop strategies for process characterization and validation as programs approach commercialization.
- Analyze data to drive process improvements and ensure product consistency and quality.
- Author, review, and revise technical documents, including protocols, reports, and SOPs.
- Provide technical expertise to resolve deviations, investigations, and out‑of‑specification events.
- Support technology transfers by participating in risk assessments and ensuring regulatory compliance.
- Assist in the qualification and validation of new equipment and processes.
- Stay updated on industry trends and suggest innovative solutions to enhance processes.
Skills & Requirements
- Bachelor's degree in Biotechnology, Biochemistry, Biology, or a related field.
- Strong knowledge of cGMP regulations and experience in regulated environments (e.g., FDA, EMA).
- Proficiency in statistical data analysis software (e.g., JMP, Minitab) and process modeling tools.
- Demonstrated ability to track and measure performance against defined metrics.
- Self‑motivated with a strong sense of urgency and the ability to lead and inspire teams.
- Passion for innovation and delivering transformative treatments for patients and families.
- Experience working in cleanroom environments and familiarity with safety protocols for hazardous materials.