We are seeking a motivated professional to support both small- and large-molecule drug product manufacturing within a leading biopharmaceutical facility. Operating as part of a global process development function, this individual will play a central role in optimizing process performance and ensuring robust product and process support for commercial and clinical drug product operations.
Key Responsibilities
- Deliver technical support for drug product manufacturing, ensuring consistency, compliance, and high process performance standards.
- Independently execute process design and qualification activities.
- Prepare and review protocols, reports, and technical documentation.
- Participate in batch simulation exercises to evaluate facility fit and identify improvement opportunities within visual inspection processes.
- Contribute to new product introductions by developing and characterizing visual inspection methods and automated visual inspection (AVI) systems for new inspection lines.
- Provide subject-matter expertise in defect classification and analysis, maintaining and updating defect libraries as needed.
- Mentor and support the development of visual inspection team members through knowledge sharing and guided training.
- Support process optimization through characterization and qualification of AVI vision recipes.
- Offer technical input for both manufacturing and commercial operations to maintain efficiency and product quality.
- Lead or assist in resolving process-related deviations, root cause analyses, and troubleshooting issues related to drug product processing and equipment.
- Maintain audit readiness and provide support during GMP inspections.
Basic Qualifications
- Bachelor's degree in Science, Engineering, or a related discipline with 2-3 years of relevant experience, or
- Master's degree with at least 2 years of directly related experience.
- Experience working in a regulated environment and/or with vision inspection systems.
Preferred Qualifications
- Over 3 years of experience in drug product process development within the pharmaceutical or biotechnology sector.
- Familiarity with the development of both liquid and lyophilized drug products in multiple presentation formats.
- A collaborative mindset and a curiosity-driven approach to problem-solving, particularly in supporting inspection process needs.
- Proven ability to think independently while working effectively within cross-functional teams.
- Excellent communication and interpersonal skills.
- Strong analytical and troubleshooting abilities with a passion for identifying and addressing root causes of complex technical issues.
