Advisor– API/DS Network Contamination & Bioburden Control Strategy

Eli Lilly and Company • Indianapolis, IN

36d

About The Position

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. Position Brand Description: The purpose of this central TSMS position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Contamination Control Strategies across the Lilly API Network. This position includes direct network oversight of facility-based contamination control strategies across an increasingly diverse array of manufacturing platforms. The position directly influences peers and Lilly facilities within the API Network as well as outsourced services through direct support of API-external manufacturing who drive commercialization of Lilly products at sites external to Lilly. The position will ensure control strategies are in-line with technical, quality and regulatory guidance applicable for the applicable platform, as well as align with business needs. This role also aids and enables building technical capability at Lilly sites to ensure the necessary capabilities are developed and in place to meet business objectives. Finally, this role involves direct engagement with small and large molecule Lilly PR&D, responsible for API process/product development, viral safety strategies etc.. Key Objectives/Deliverables Develop deep technical understanding of contamination control requirements across a diverse array API production platforms. Ensure contamination controls are applied commensurate with modality-specific risk factors (e.g., for chemically-derived crude synthesis and API purification, microbial-derived biologics, well-characterised biologics produced in mammalian cell culture and advanced therapeutic medicinal products). Understand and influence the application of industry and regulatory expectations pertaining to all elements of contamination control including platform specific control strategies (including viral safety where applicable), facility and equipment control requirements (closures, cleaning, steam etc.), production practices, process monitoring requirements,environmental control and monitoring, and other product protection control related systems. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. Provide technical support to new API/DS sites and site expansions during design and start-up activities to ensure CCS programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. Provide network support to Lilly sites during new product introductions/commercialization and for major process changes impacting contamination control at Lilly sites. Provide direct support API External Manufacturing for API/DS tech transfers, commercialization/ manufacturing at our contract manufacturing organisations. Support regulatory applications and submissions, including marketing authorization review/approvals, as required, and support during Q&A. Provide oversight across the product portfolio to ensure consistency and that new emerging regulatory trends are addressed. Provide mentoring leadership to site SMEs to help build capability, particularly at the newer sites or existing sites where deep technical expertise is lacking. Work closely with global molecule stewards, site stewards and cross-functional SMEs to drive control strategy development and for alignment within product platforms. Provide technical support for significant network investigations to help determine root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across other sites. Support Central TS/MS Contamination and Adventitious Agent Control initiatives and programs including global quality standard development, CCS workstreams, new site and site expansion startup, KPI development, and new regulation assessment. Monitor performance metrics, report and provide insights to inform decision making to drive further improvements. Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Contamination and Bioburden Control Strategies.

Requirements

• 7+ years’ experience in Pharmaceutical Manufacturing with a focus on technical support of synthesis/fermentation/cell culture and purification stages of API, Drug Substance– front line manufacturing support (clinical/commercial) development of contamination control elements for manufacturing stages/systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment.
• Deep technical understanding of contamination control requirements and regulatory expectations for API manufacturing.
• Knowledge of QC procedures for bioburden, endotoxin, adventitious agents, environmental monitoring.
• Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities.
• Strong written and oral communication skills
• Ability to consult site scientists and engineers and Quality Control in contamination control principles, applications and applied pharmaceutical microbiology.
• Understanding of cGMP’s, policies, procedures, and guidelines relating to bioburden-controlled manufacturing or sterility assurance.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals
• Clear understanding of all cGMPs, polices, procedures, guidelines, and ensuring a fair/equitable/safe work environment.
• Approximately 25% travel
• BS/MS/PhD in a biological science (or equivalent work experience) or engineering discipline (Microbiology-preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.).

Nice To Haves

• Additional relevant industrial experience in any of the following associated commercial pharmaceutical manufacturing platforms Peptide/Oligonucleotide, Monoclonal Antibody, small molecule, cell banking, and ATMP Manufacturing.
• Direct experience supporting regulatory affairs and site Quality inspections.
• Experience providing CCS related oversight of new and existing facilities including inspection readiness and preparation, root cause analysis, CAPA, and Quality Risk Management.
• Strong capability to influence personnel and management across the organization.
• Close interaction with quality to enable internal audits that identify risks.

Responsibilities

• Develop deep technical understanding of contamination control requirements across a diverse array API production platforms.
• Ensure contamination controls are applied commensurate with modality-specific risk factors (e.g., for chemically-derived crude synthesis and API purification, microbial-derived biologics, well-characterised biologics produced in mammalian cell culture and advanced therapeutic medicinal products).
• Understand and influence the application of industry and regulatory expectations pertaining to all elements of contamination control including platform specific control strategies (including viral safety where applicable), facility and equipment control requirements (closures, cleaning, steam etc.), production practices, process monitoring requirements,environmental control and monitoring, and other product protection control related systems.
• Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
• Provide technical support to new API/DS sites and site expansions during design and start-up activities to ensure CCS programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability.
• Provide network support to Lilly sites during new product introductions/commercialization and for major process changes impacting contamination control at Lilly sites.
• Provide direct support API External Manufacturing for API/DS tech transfers, commercialization/ manufacturing at our contract manufacturing organisations.
• Support regulatory applications and submissions, including marketing authorization review/approvals, as required, and support during Q&A.
• Provide oversight across the product portfolio to ensure consistency and that new emerging regulatory trends are addressed.
• Provide mentoring leadership to site SMEs to help build capability, particularly at the newer sites or existing sites where deep technical expertise is lacking.
• Work closely with global molecule stewards, site stewards and cross-functional SMEs to drive control strategy development and for alignment within product platforms.
• Provide technical support for significant network investigations to help determine root cause and implement appropriate corrective actions.
• Share best practices / learnings / CAPAs across other sites.
• Support Central TS/MS Contamination and Adventitious Agent Control initiatives and programs including global quality standard development, CCS workstreams, new site and site expansion startup, KPI development, and new regulation assessment.
• Monitor performance metrics, report and provide insights to inform decision making to drive further improvements.
• Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Contamination and Bioburden Control Strategies.

Benefits

• employees also will be eligible for a company bonus (depending, in part, on company and individual performance)
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level