Join a global leader in biopharmaceuticals dedicated to tackling the world's most challenging diseases. This pivotal role sits within the Technical Services Team, focusing on the seamless transition of clinical products to commercial launch. You will act as the strategic bridge between clinical manufacturing and commercial business units, ensuring life-changing innovations reach patients worldwide.
Key Responsibilities
- Project Leadership: Lead matrixed teams to manage New Product Introduction (NPI) activities, ensuring projects stay on schedule, within scope, and on budget.
- Technology Transfer: Oversee technical transfer protocols, documentation, and execution from development through to commercial manufacturing.
- Cross-Functional Interface: Act as the primary technical point of contact between Manufacturing, Quality, Regulatory, and Supply Chain teams.
- Process Optimization: Define control strategies to ensure robust process performance, compliance with cGMP, and successful regulatory submissions.
- Technical Problem Solving: Lead investigations into process deviations and root cause analysis; provide expert troubleshooting for complex manufacturing issues.
- Mentorship: Support the career growth and technical development of team members.
Qualifications & Experience
- Education: Bachelor's, Master's, or PhD in a relevant scientific or engineering discipline.
- Experience Requirements:
- BS: 8+ years of relevant experience.
- MS: 6+ years of relevant experience.
- PhD: 5+ years of relevant experience.
- Technical Expertise: In-depth knowledge of manufacturing principles, Technical Transfers, and Process Validation within a regulated environment.
- Communication: Exceptional interpersonal skills with the ability to influence senior management and lead high-performing teams.
- Execution: Strong organizational skills with a proven ability to think critically and manage resources independently in a fast-paced environment.
