Job Summary:

The Technical Services Associate-I will assist with and/or execute process and product improvement studies supporting commercial product lifecycle management activities for pharmaceutical products. Working collaboratively with multiple teams, the position will have the chance to make a significant impact by improving existing products, addressing manufacturing issues, evaluating new technologies and ingredients, seeking cost savings, and assisting with the development and transfer of products and processes.

Job Responsibilities

• Carries out responsibilities in accordance with Avevas policies, procedures, and safety rules in accordance with local, state and federal laws.
• Provides support, coordinates, and executes experimental studies supporting improvements or modifications to commercial products and/or processes.
• Interfaces with R&D, Production, Analytical Development / QC, Quality Assurance, Engineering and Regulatory departments to carry out project objectives.
• Assists with troubleshooting process problems and assists in process optimization.
• Assists with the investigation of process failures and discrepancies to assess impact upon product quality and validation status.
• Evaluates and implements cost-saving initiatives, including implementation of alternative raw materials, supplies, and procedures.
• Prepares specifications for alternative raw materials and components.
• Supports improvements in manufacturing and control systems including corrective and preventative actions (CAPA).
• Supports technology transfer initiatives within the company or with external facilities.
• Assists with or leads drafting of protocols to establish product and process specifications and procedures.
• Prepares final reports and assures they are approved through proper channels.
• Assists the R&D department with the development and scale-up of manufacturing processes.
• Assists with or leads the preparation of manufacturing batch records (MBRs) and supporting documents.
• Provides supervision of manfactruing activities supporting R&D/Tech Services projects, such as supervising beldning, coating, and packaging operations.
• Performs related duties as assigned.