Sterility Assurance Scientist Full-time NEW

Scientist/Engineer – Sterility Assurance – Technical Services/Manufacturing Science (TS/MS)

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 Scientist/Engineer – Sterility Assurance – Technical Services/Manufacturing Science (TS/MS) role is a technical position that develops and implements the site's sterility assurance related initiatives and provides technical leadership with regard to sterility assurance & environmental monitoring strategies.

Primary objectives include the start-up and compliant manufacturing of RTP products, particularly as it relates to development and implementation of sterility assurance strategies, including environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, and sterility assurance risk management. The scope of the role includes syringe filling operations for commercially manufactured products targeted for transfer to the RTP site.

Responsibilities:

• Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems
• Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination
• Assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk
• Provide technical support for all start-up activities related to sterility assurance programs (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.)
• Ensure site's environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level
• Provide technical guidance to the Process Team for sterility assurance programs
• Lead or provide technical support for root cause investigations related to sterility assurance programs
• Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements
• Perform periodic review of environmental monitoring data
• Lead or support risk assessments related to sterility assurance programs
• Create, execute, review, and/or approve technical documents related to sterility assurance programs
• Create, execute, and/or evaluate change controls related to sterility assurance programs
• Continually educate self and others to drive improvements and to remain current with regulatory expectations and industry trends
• Participate in continuous improvement projects to improve quality performance at the site
• Participate or provide guidance for sterility assurance programs during internal and external audits, including regulatory inspections, 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
• Serve as sterility assurance interface external to the RTP site
• 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 Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
• Experience supporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services/MSAT, quality assurance, etc.)

Additional Preferences:

• In depth knowledge of parenteral drug product manufacturing
• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills
• Strong oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
• Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations
• Demonstrated successful leadership of cross-functional teams
• Experience with data trending and analysis
• Ability to analyze complex data and solve problems

Other 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

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 – $171,600.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.