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Scientist/Engineer - Technical Services Manufacturing Science - Device Assembly
Company | BioSpace |
Address | Durham, NC, United States |
Employment type | FULL_TIME |
Salary | |
Category | Internet News |
Expires | 2023-07-17 |
Posted at | 10 months ago |
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
- Provide technical support for all start-up activities (e.g., tech transfer, process validation)
- Serve as technical interface external to the RTP site
- Ensure that an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps
- Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities
- Provide Audit support, as needed
- Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda
- Provide technical support for non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability
- Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives
- Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc.
- Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain
- Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems
- Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability
- Lead risk management activities as it pertains to products
- Support and/or own the technical agenda for the product or validation process
- Drive the stability strategy for RTP products
- Minimum 3 years experience
- BS or MS in engineering, or other related scientific discipline
- Technical Transfer experience, including equipment qualification and process validation
- Demonstrated successful leadership of cross-functional teams
- 5-7 years of experience preferred.
- Experience in TS/MS, MSAT, Operations, particularly in the areas of device assembly and packaging
- Experience supporting cGMP manufacturing operations
- Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
- Previous experience with deviation and change management systems, including Trackwise
- Knowledge of CMC aspects of drug product manufacturing
- Strong self-management and organizational skills
- Strong interpersonal and teamwork skills
- Occasional extended hour and / or off-hour work may be required
- Position will be based out of RTP site with ability to travel to Indianapolis and other global Lilly sites as required
- Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.)
- Role is Monday through Friday based
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