What are the responsibilities and job description for the Chemical Engineering Manager position at ARx, LLC?
About the Position:
We are seeking an experienced Chemical Engineering Manager to join our team at ARx, LLC. In this role, you will be responsible for overseeing the development, scaling up, and validation of processes used for producing specialty drug delivery products in compliance with 21 CFR 211 and other relevant regulatory requirements.
Key Responsibilities:
- Oversee the development, scaling up, and validation of processes used for producing specialty drug delivery products.
- Work closely with cross-functional teams, including R&D, Quality, Operations, Marketing, and Clients, to achieve successful outcomes.
- Perform a variety of engineering tasks, including preparation of experimental and validation protocols, and execution thereof in chemical processing, coating, and slitting/finishing areas.
- Design and conduct experiments, collect data, and perform data analysis and interpretation using statistical tools (SPC, ANOVA, Regression, etc.).
- Generate reports and make decisions based on statistical data interpretation.
- Lead problem-solving efforts and take initiative to make changes through change control procedures.
Requirements:
- Bachelor's degree in an Engineering discipline (Chemical preferred); other technical degrees will be considered depending on complement of relevant experience & capabilities.
- Minimum of five (5) years experience in cGMP manufacturing environment.
- Supervision experience required, manufacturing supervision experience preferred.
