What are the responsibilities and job description for the Engineering Manager for Production Operations position at ARx, LLC?
About the Role
The Engineering Manager for Production Operations at ARx, LLC is responsible for providing technical oversight to production of developmental, scale-up, and validation materials. This role involves developing modified and new processes for producing specialized drug delivery therapeutic products, working in close collaboration with cross-functional teams to accomplish successful outcomes, and performing a variety of engineering tasks in chemical processing, coating, and slitting/finishing areas in compliance with 21 CFR 211 Regulatory standards.
The successful candidate will have excellent engineering principles, concepts, and methodology expertise, as well as experience in cGMP manufacturing environments. This role requires strong communication and leadership skills, as well as the ability to work effectively in a team environment.
Key Responsibilities
- Develop modified and new processes for producing specialized drug delivery therapeutic products
- Work in close collaboration with cross-functional teams to accomplish 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 in compliance with 21 CFR 211 Regulatory standards
Requirements
- Bachelor's degree in an Engineering discipline (Chemical preferred)
- Minimum of five years' experience in cGMP manufacturing environment
- Supervision experience required, manufacturing supervision experience preferred
- Excellent ability to effectively organize thoughts, information, and data; articulate and convey them (oral and written) concisely and clearly to others
What We Offer
- Opportunity to work in a dynamic and fast-paced environment
- Collaborative team atmosphere
- Competitive salary and benefits package
The Engineering Manager for Production Operations at ARx, LLC is responsible for providing technical oversight to production of developmental, scale-up, and validation materials. This role involves developing modified and new processes for producing specialized drug delivery therapeutic products, working in close collaboration with cross-functional teams to accomplish successful outcomes, and performing a variety of engineering tasks in chemical processing, coating, and slitting/finishing areas in compliance with 21 CFR 211 Regulatory standards.
The successful candidate will have excellent engineering principles, concepts, and methodology expertise, as well as experience in cGMP manufacturing environments. This role requires strong communication and leadership skills, as well as the ability to work effectively in a team environment.
Key Responsibilities
- Develop modified and new processes for producing specialized drug delivery therapeutic products
- Work in close collaboration with cross-functional teams to accomplish 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 in compliance with 21 CFR 211 Regulatory standards
Requirements
- Bachelor's degree in an Engineering discipline (Chemical preferred)
- Minimum of five years' experience in cGMP manufacturing environment
- Supervision experience required, manufacturing supervision experience preferred
- Excellent ability to effectively organize thoughts, information, and data; articulate and convey them (oral and written) concisely and clearly to others
What We Offer
- Opportunity to work in a dynamic and fast-paced environment
- Collaborative team atmosphere
- Competitive salary and benefits package