- Supports the project team with respect to scaling up processes, new equipment and procedures, equipment and process validation, and manufacturing of development, stability, and process qualification batches.
- Assigned projects will have a limited scope.
- Assists in preparing the manufacturing site for the manufacture of new products.
- Communicates as necessary with the various plant departments, other support departments, project team members, and other internal customers.
- Prepares master batch records and protocols for the manufacture of development, stability, and process performance qualification batches.
- Works with management to translate development findings into manufacturing processes. Technically assesses manufacturing processes by risk analysis method(s) and uses results to design robust manufacturing processes.
- Provides technical assessment of changes in manufacturing through appropriate review of documentation and testing results.
- Executes necessary investigative studies to address product deviations and changes to a manufacturing process.
- Supports product life cycle through execution of continued process verification reports.
- Assesses feasibility of simple research and design concepts related to modernizing a product/product family or enhancing knowledge of a product/product family which includes but not limited to compatibility studies for tubing, vials, and stoppers, thermal cycling studies, light studies, and studies which support product insert.
- Technical reviewer for tables and basic protocols and final reports.
- Perform any other tasks/duties as assigned by management.
- Bachelor's degree in a physical science or engineering or master's degree in business administration.
- At least ten years of pharmaceutical manufacturing and sterile product transfer experience.
- Ability to work independently or in collaboration with others.
- In-depth understanding and application of project management principles, concepts, practices, and standards.
- Proficient in current Good Manufacturing Practices and other applicable FDA, USDA and EU regulations.
- Excellent written and verbal communication skills.
- Solid organizational skills including attention to detail and multitasking skills.
- Proficient in MS Excel, MS Word, MS Project, and MS PowerPoint.
- Must be willing to travel regionally and/or nationally throughout the U.S.
- Job assignments may require temporary relocation up to 12 months or more.
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Description
Job Description
Job DescriptionTechnology Transfer Project Manager – On-Demand Staff Augmentation
The Technology Transfer Project Manager is responsible for assisting with the transfer and implementation of defined processes for new and/or modified products from one manufacturing site to another manufacturing site. This person is responsible for maintaining the product life cycle which includes development, stability, process performance qualification and cleaning validation/verification.
Responsibilities:
Requirements:
