Job Description:
- Manage API projects (including process equipment) from initiation through to completion, including planning, execution, monitoring, and closing phases.
- Coordinate with cross-functional teams including Process Development, Manufacturing, Quality Assurance, and Regulatory Affairs to ensure project objectives are met.
- Develop project plans, timelines, and budgets, and track project progress against these parameters.
- Identify and mitigate project risks, ensuring compliance with safety standards and regulatory requirements.
- Communicate project status updates to stakeholders and management on a regular basis.
- Collaborate with external vendors and contractors as needed to support project goals.
- Lead or contribute to continuous improvement initiatives related to API manufacturing processes.
- Prepare and present technical reports, documentation, and presentations as required.
Requirements:
- Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, or related field.
- Proven experience in project management within the pharmaceutical industry, with specific experience in API projects highly desirable.
- Strong knowledge of cGMP regulations and guidelines, FDA requirements, and other relevant regulatory standards.
- Excellent organizational skills and ability to manage multiple projects simultaneously.
- Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.
- Proficiency in project management tools and software (e.g., Microsoft Project, Smartsheet).
- Analytical mindset with a focus on problem-solving and decision-making.
