Sterility Assurance Scientist - Advanced Therapies Manufacturing

Initial Therapeutics, Inc.; Lebanon (IN); On-site; USD 64,000 - 143,000; Full time

Job summary

An innovative company is constructing a cutting-edge facility in Indiana, focused on gene therapy manufacturing. This role offers a unique opportunity to contribute to the startup of a state-of-the-art site, emphasizing sterility assurance and environmental monitoring. Ideal candidates will possess a strong background in microbiology and experience in cGMP manufacturing. Join a team dedicated to improving lives through groundbreaking therapies and be part of a collaborative environment that values safety and quality. This is your chance to make a significant impact in the healthcare industry.

Benefits

401(k) Plan

Pension

Vacation Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Employee Assistance Program

Fitness Benefits

Employee Clubs and Activities

Qualifications

• 1+ year of experience in cGMP manufacturing and sterility assurance.
• Strong self-management and organizational skills are essential.

Responsibilities

• Develop and implement sterility assurance initiatives for gene therapy.
• Provide technical support for cleaning deviations and root cause analysis.

Skills

Microbiology

Environmental Monitoring

Sterility Assurance

Data Analysis

Problem Solving

Teamwork

Communication

Education

Bachelor in Microbiology

Bachelor in Biology

Bachelor in Biochemistry

Bachelor in Chemical Engineering

Job 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.

Company Overview

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 currently constructing a cutting edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply.

This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.

Job Description

Sterility Assurance – Technical Services/Manufacturing Scientist (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 gene therapy drug product and drug substance, 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.

Key Objectives/Deliverables

• Understand the scientific principles required for manufacturing gene therapy drug products, including the interaction of the chemistry, equipment, aseptic processes, sanitization, and sterilization.
• 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
• Provide technical support on cleaning deviations/events and assist in root cause analysis.
• 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
• Serve as cleaning/sterility assurance interface external to the LP2 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
• Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities

Basic Requirements:

• Bachelors in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
• 1+ year of experience supporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance validation, microbiology laboratory, TS/MS, quality assurance, etc.)

Additional Preferences:

• In depth knowledge of gene therapy 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

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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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

$64,500 - $143,000

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.

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