Description:
This is an exciting and challenging role where you will have technical ownership of commercially launched products and new product introductions to the site (spanning developmental studies and clinical manufacturing up to validation and post-commercialization changes) with a particular focus on the manufacturing process, scale-up, equipment understanding, and statistical evaluations. Thorough hands-on support of bulk manufacturing, driving production performance KPIs, proactively championing new technologies, and leading troubleshooting investigations - all with a high sense of urgency and high level of technical confidence with full GMP compliance.
Roles And Responsibilities
- Continuous oversight with a hands-on mentality on product performance, periodic reviews with senior leadership, and timely authorship of product baseline reports
- Leading investigations of process deviations with a high sense of urgency to quantify the potential impact on product quality
- Authoring and issuing Batch manufacturing records and technical protocols
- Technical support for new product introductions until validation
- Applying sound and critical reasoning to troubleshoot complex process challenges
- Tracking and trending of product and process data, statistical evaluation of data
- Creating and delivering effective and persuasive presentations on complex topics to upper management.
- Actively drive plant performance, with a special focus on cost improvement programs (CIP)
- Function as SME during Inspections and Audits
Qualifications
- A third level qualification in Chemistry or related Science, preferably a bachelors degree
- 5 years relevant experience in a pharmaceutical manufacturing plant and/or training; or equivalent combination of education and experience.
- Good understanding of 21CFR / cGMP documentation and electronic systems requirements.
- Good relationship building skill with the ability to align individuals and teams to achieve business objectives
- Experience in managing through metrics