Our client, in the life sciences industry, is seeking a remote Director, Technical Operations. This position is responsible for initiating, coordinating, and completing technical projects as assigned. These projects may involve but are not limited to: validating a manufacturing process, scale-up/transferring a new product/process into production or to a contract manufacturing site, troubleshooting a given process or product, evaluating a new or existing raw material, and performing equipment/system qualifications.

 

Key Responsibilities and Essential Functions:

• Responsible for scale-up and transfer of products/processes to contract manufacturing sites.
• Validates products/processes in-house or at contract sites to meet project timelines.
• As required, evaluate new or existing raw materials to support the manufacture of commercial/experimental products.
• Optimizes new or existing processes to enhance process efficiency and product quality.
• Troubleshoots product and process problems both in-house and at contract sites.
• Reviews documentation related to commercial product manufacture (manufacturing records, specifications, DMFs, etc.) and provides pertinent and timely comments.
• Completes departmental documentation (reports, forms, SOPs, etc.) in a timely manner, as required.
• Performs physical testing on raw materials/finished products, as necessary, to meet the objectives of an experimental plan.
• Works as Technical Operations representative on cross-functional teams, collaborating with clinical affairs, regulatory affairs, project management, scientists, and outside experts.
• Manages cross-functional project teams as required.

 

Qualifications:

• B.S. or M.S. in the Sciences or Engineering or scientific equivalent required.
• Minimum of 10 years of industry experience.
• Must understand cGMP regulations.
• Familiarity with sustained-release products and/or the solid dosage form manufacturing is a plus.
• Must understand the principles of process and cleaning validation and bulk pharmaceutical excipient guidelines.
• Must work independently and demonstrate a track record in managing multiple activities effectively.
• Must be capable of identifying and solving problems and inefficiencies.
• Must demonstrate excellent written and verbal communication skills.
• Must have computer skills including Microsoft Word and Excel.

Posted On: Wednesday, August 17, 2022