Principal Scientist, TSMS Contamination Control Strategy - ADN RAMP Team

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.Organization Overview:At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.Position Brand Description:The Lilly Scientist - API/Dry Product Network is rapidly expanding to meet the demand for new products, and several new greenfield sites are under construction and will be starting up in the coming years. The new sites are staffed based on full-scale, steady state production, however additional surge capacity is needed to support the site start-up and help quickly ramp to full capacity rates.The Scientist - ADN RAMP (Rapid Access to Medicines for Patients) team is a cross-functional team that will bring deep manufacturing expertise and will support each site start-up through Operational Excellence knowledge, rapid troubleshooting and problem-solving capability, and surge capacity resources. This unique opportunity will enable team members to work at our new sites, create a larger Lilly network, build and use their technical skills, and learn leadership skills through formal training and on-the-ground experiences. This team will also build strategies to help other new Lilly sites to start up faster, helping to accelerate Lilly’s vision of serving more patients.Success in this challenging role will require supporting the sites through startup, through direct technical execution, coaching next employees, and strong collaboration – and development of the local technical and operational teams to be ready for full operation.The team will directly report through their respective functions but will be coordinated by the Ramp Team Sr. Director.Key Objectives/Deliverables :Responsible for the development, implementation and establishing ongoing monitoring of the Contamination Control Strategy (CCS) for new site facilities including but not limited to:Facility /Utility Controls:

In collaboration with the New Site CCS team, design, implement, support validation of and maintenanceofroutine and Batch Specific environmental monitoring (EM) programs.

Where necessary, design, implement, support validationof Clean Utilities microbiological monitoring programs.

Support aseptic qualification /requalification programs.

Liaise with engineering on the New Facility design requirements to support CCS such as but not limited to pressurization cascades, area classification, material, personnel and equipment flows.

Material controls:

Provide microbiological control strategy support for Raw Materials.

Provide the Microbiological Controls to support the Resin Management programs where necessary.

Liaise with Quality Assurance to ensure microbiological controls are considered in the application of Vendor Management such as but not limited to approval of GMP Service providers, risk assessment of GMP Consumables and approval of new raw materials.

Equipment Controls:

Liaise with cleaning validation group on microbial requirements for cleaning validation.

Provide Microbiological support to C&Q such as but not limited to commissioning and qualification of cGMP autoclaves and Parts Washers (SOP and COP studies) and steam in place (SIP) systems in Biotech facilities.

Provide Microbiological support for process support qualification (PSQ) studies such media challenges, Media and Buffer Hold Time Studies and resin lifetime studies.

Liaise with Engineering on filtration requirements to support product specific elements of contamination control strategy.

Product Controls:

Ensure implementation of the microbiological requirements for the integrated product control strategy.

Provide direction on handling of non-conforming results.

Support Microbiological trend analysis and metrics reporting as required.

Member of the deviation response team for management of suspect Microbiological Contamination events.

Provide microbiological support for procedural and batch record updates as required.

Stay current with Industry trends and updates to applicable guidelines such as ISO standards and GMP requirements within area of responsibility.

Coach and mentor site CCS teams on implementation and maintenance of all CCS programs.

Basic Requirements:

BSc Microbiology, Biochemistry or related science field with 8-10 years’ experiencein pharmaceuticalmanufacturing.

MScMicrobiology, Biochemistryor science-related fieldwith minimum 5 years appropriate industry experience.

Additional Skills/ Preferences :

Deep technical interest and understanding of Contamination Control Strategy.

Excellent verbal and written communications skills.

Strong analytical and problem-solving skills.

Collaborative skills with operations, process engineering, QCL and other process team members.

Technical knowledge of microbial and viral product control.

Ability to coach others.

Ability to influence without authority.

Ability to clarify and simplify complex issues.

Strong trust building with peers and leaders.

Willing to work off-shift hours as needed to support project milestones and training of new employees.

Other Information:The Scientist - ADN RAMP team will support multiple new API/Dry Products sites in various locations (US and OUS). Significant travel may be required to current startup sites in order to meet business needs, along with potential short-term assignments across the network (can include international relocations). Candidates must be mobile and flexible.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 - $167,200Full-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.#WeAreLilly