PREFERRED KNOWLEDGE/SKILLS:

• Knowledge of scientific methodology and development in the pharmaceutical industry.
• Understanding of Good Manufacturing Practices.
• Proficiency in Microsoft Office Suite.
• Excellent critical thinking, problem-solving, and technical writing skills.
• Effective communication and presentation skills, with the ability to lead technical discussions.
• Ability to evaluate data, develop technical solutions, and make recommendations.
• Knowledge of regulatory requirements (e.g., FDA, EMA, ISO) and industry standards.
• Proficiency in quality management systems (QMS) and relevant software tools.

QUALIFICATIONS:

Bachelor’s Degree required ideally in Chemistry, Biology, or a related physical science with a minimum of 5 years of relevant experience. An equivalent combination of education and relevant experience may be considered.

PHYSICAL REQUIREMENTS:

• Stand for extended periods.
• Handle chemicals and operate various laboratory equipment.
• Lift up to 40 pounds without assistance.
• Adhere to all Good Manufacturing Practices (GMP) Safety Standards.
• Work in cold room/freezer environments (-22°F/-6°C).
• Work in laboratory and office settings.
• Use personal protective equipment (PPE) such as safety glasses, gowning, gloves, lab coat, and ear plugs.

• Collaborate with cross-functional teams to support product and process development in commercial manufacturing.
• Lead technical planning and client interactions, ensuring alignment across multiple projects.
• Apply risk-based approaches to process scale-up and commercialization, developing mitigation strategies.
• Prepare batch records, protocols, and reports for development, validation, and routine production.
• Act as technical steward for assigned products, supporting routine manufacturing.
• Investigate new scientific methodologies for controlling raw materials, intermediates, and final products.
• Implement strategies and technical solutions to meet client needs.
• Identify and document deviations from standard operating procedures (SOPs), quality standards, or regulatory guidelines.
• Conduct product investigations and develop CAPAs.
• Analyze deviation trends and provide insights for continuous improvement.