- 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
- Provide technical support for all start-up activities (e.g., tech transfer, process validation)
- Provide technical support for non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability
- 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.
- Ensure that an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps
- Support and/or own the technical agenda for the product or validation process
- Lead risk management activities as it pertains to products
- Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability
- 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
- Drive the stability strategy for RTP products
- Serve as technical interface external to the RTP site
- Provide Audit support, as needed
- Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives
- Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain
- Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities Basic Requirements:
- BS or MS in engineering, or other related scientific discipline
- Minimum 3 years experience Additional Preferences:
- Knowledge of CMC aspects of drug product manufacturing
- Experience supporting cGMP manufacturing operations
- Strong interpersonal and teamwork skills
- Strong self-management and organizational skills
- Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
- Experience in TS/MS, MSAT, Operations, particularly in the areas of device assembly and packaging
- Technical Transfer experience, including equipment qualification and process validation
- Demonstrated successful leadership of cross-functional teams
- Previous experience with deviation and change management systems, including Trackwise
- 5-7 years of experience preferred. Additional Information:
- Role is Monday through Friday based
- Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.)
- 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 Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly -
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Scientist/Engineer - Technical Services Manufacturing Science - Device Assembly - Durham, United States - Eli Lilly and Company
Description
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 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.
Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up.
The Device Assembly Senior/Principal Scientist – Technical Services / Manufacturing Science (TS/MS) role is a technical position that develops and implements a technical agenda and is responsible for providing technical leadership for commercial TS/MS activities within Lilly-RTP site. This role will initially focus on the delivery of the Device Assembly operations but may also engage in support of packaging operations.
Primary objectives include the start-up and compliant manufacturing of RTP products, including implementation of the process control and validation strategy. The scope of the role includes device assembly and packaging for commercially manufactured products targeted for transfer to the RTP site.
While this role is not expected to be the technical expert on all products and platforms, it is expected to be the expert in regulatory, internal, and other requirements. A key part of this role is ensuring that there is consistency in approach / processes throughout the product lifecycle, from tech transfer to regulatory submission and beyond to routine manufacturing.
Responsibilities:
