Eli Lilly

Advisor– API/DS Network Contamination & Bioburden Control Strategy

Eli Lilly • $129K — $189K *
Kenosha, WI 53142In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
2 months ago
Job Overview by Ladders

Qualifications

  • 7+ years in Pharmaceutical Manufacturing focused on technical support for API processes.
  • Deep technical knowledge of contamination control and regulatory expectations.
  • Experience with QC procedures for bioburden, endotoxin, and environmental monitoring.
  • Strong data analysis and problem-solving skills with attention to detail.
  • Excellent communication skills, both written and oral.
  • Ability to advise on contamination control principles in a regulatory environment.

Responsibilities

  • Develop and manage contamination control strategies for various API production platforms.
  • Ensure compliance with regulatory expectations for contamination control measures.
  • Provide technical support during the startup of new API sites and expansions.
  • Support new product introductions and major process changes affecting contamination control.
  • Engage with external manufacturing for tech transfers and commercialization activities.
  • Mentor site SMEs to strengthen technical capabilities in contamination control.
  • Monitor performance metrics and report insights for continuous improvement.

Benefits

  • Comprehensive medical, dental, and vision benefits.
  • 401(k) plan with company matching contributions.
  • Generous vacation policy and flexible spending accounts.
  • Employee assistance program and wellness benefits.
  • Participation in employee resource groups and community involvement opportunities.
Full Job Description
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.  
Basic 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
Additional Preferences:
  • 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.
Education Requirements:
  • BS/MS/PhD in a biological science (or equivalent work experience) or engineering discipline (Microbiology-preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.).
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is $129,000 - $189,200 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.

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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