Sanofi US jobs in South San Francisco, CA - 76 jobs

Job Title: Area Business Manager - Allergy/ENT - Central Coast, CA About the job Sanofi focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Sanofi has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases, oncology, immunology and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Sanofi's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. The Area Business Manager (ABM) is responsible for engaging Allergists and ENTs, and other key customers within an assigned geography and presenting clinically focused selling messages to create and grow revenue and to consistently deliver product goals related to asthma, CRSwNP, atopic dermatitis, CSU and EOE indications. The ABM will demonstrate initiative, drive, independence, and take ownership for meeting and exceeding individual business goals. This will be accomplished by driving performance and delivering results in a compliant manner with a high degree of integrity strictly following all Sanofi US policies and in compliance with all policies and procedures governing the promotion of pharmaceutical/biological products in the US. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you'll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: Engage Allergy/Immunology/ENT customers within assigned geographical territory and deliver clinically focused message to introduce, launch, grow brand-share and revenue and to consistently deliver on product goals for asthma, CRSwNP, atopic dermatitis, CSU and EOE indications. Collaborate and coordinate with other key field-based stakeholders such as Regeneron Sales Professional counterparts, Medical Science Liaisons, Field Reimbursement and Market Access teammates, Thought Leader Liaisons, and others in their territory to proactively address customer needs, identify market dynamics and trends, develop strategies which support brand and corporate objectives, and ensure optimal account success within their assigned geography. Develop strong working relationships with immunology experts and all additional Allergy/ENT specialists in assigned geography as well as biologic coordinators, office staff and other important health care personnel and key patient advocacy support groups as directed. Drive results by identifying key opportunities and developing strategic business plans to generate product utilization and grow territory business. Plan, organize, and execute local promotional speaker programs and activities. Maximize budget allocated to the geographic territory to support execution of strategies and tactics and generate/grow the business. Participate and help lead initiatives to support sales success as assigned (e.g. participate in industry related congresses, local and regional meetings and medical conferences). Own business opportunities within respective geographic area, which includes coordination and calling upon large group practices and other key targets to drive overall product results. Establish relationship with thought leaders in assigned territory. Primary objective is to drive industry leading customer value. About You Basic Qualifications: Bachelor's degree from an accredited four-year college or university. Minimum 3 years of pharmaceutical, medical device or biotech Sales experience, OR relevant clinical experience. Demonstrated ability to learn and apply technical and scientific product-related information. Ability to travel to meetings/trainings/programs as necessary - additional travel may be required within the assigned territory. Proven success and positive track record of consistent sales performance in complex markets with diverse customer segments operating with a high degree of integrity within compliance guidelines. Ability to operate as a “team player” in cooperation with collaboration partners and internal colleagues to reach common goals. Valid Driver's License. Preferred Qualifications: 2 years selling sub-cutaneous self-injectable (or office administered IV) biologics. 2 years selling experience in asthma or other immunology disorders such as atopic dermatitis, psoriasis, multiple sclerosis, Crohn's disease, or ulcerative colitis strongly preferred. 2 years selling experience calling on Allergists and/or ENTs. Co-promotion experience preferred. Demonstrate advanced clinically based selling skills. Results oriented with a proven track record of success with product launches. Experience with in-servicing and training office staff, nurses and office managers. Demonstrate a passion and learning aptitude for science and is proactive in strengthening knowledge related to disease-state, treatment options and healthcare trends. Highly organized with strong account management skills. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Remote #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $125,250.00 - $208,750.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

A global biopharmaceutical company is looking for a Principal Scientist in Innovation Management. The role involves the development of upstream processes, oversight of biopharmaceutical production, and integration of digital tools in manufacturing. Candidates must have significant experience in biopharmaceutical manufacturing and possess strong leadership capabilities. This exciting opportunity advocates for collaboration, innovation, and a commitment to high-quality standards in a dynamic working environment. #J-18808-Ljbffr

Expertise in equipment and manufacturing process, capability to support multiple process areas 3+ years of leadership and project management skills; Lead executions of Manufacturing related engineering projects. Works on several different projects and prioritizes these projects with guidance Proficiency in all of the following fields equipment, process/materials, maintenance, project delivery Support investigations, owns CAPAs, and responsible or product impact assessment, and risk assessments related to manufacturing processes. Lead solving activities to resolve critical issues, planned and unplanned activities, and anticipate future engineering developments within maintenance/process area Designs studies, accomplishes experiments/protocols and perform data analysis. Develop and optimize processes within own area of process engineering . • Track, trend, and analyze in-process data using statistical process control (SPC) methods. Monitor and improve process performance. Share technical knowledge and expertise with personnel in AstraZeneca to aid technical developments within the organization. Recommend and implement transformation/ continuous improvement initiatives within site with focus on cost saving and improvement of quality and efficiency. Employ Good Engineering Practices to streamline project executions ;collaborates with multi-functional teams to solve problems Provide mentorship and coaching to junior engineers, interns, and manufacturing technicians Guide execution of processes (e.g., validation, qualification, operation, evaluation and troubleshooting of process deviations) within process engineering area. Participate in communications with relevant internal teams (e.g., regulatory) for management of change control. Guide and track compliance of own work and work of others with SHE and other applicable standards and regulations. Provide engineering solutions to manufacturing challenges and meet all safety, quality, supply and requirements. Develop contacts across a range of departments and external groups acting as engineering representative. Equipment Management Prepare equipment for qualification activities, including but not limited to: TOP preparation and review, initial testing and qualification readiness Handles production equipment. Maintain equipment maintenance strategies, and equipment lifecycle management Lead/ guide planning, managing, and monitoring of major manufacturing and maintenance plan projects from concepts to implementation Lead equipment specification, design, build, commissioning and qualification to meet technical/safety/ and business Essential Requirements: Bachelor's degree in Chemical or Mechanical Engineering Minimum of 3 years relevant experience. Breadth of experience to establish credibility with key stakeholders. Industry experience in a GMP environment Preferred Experience: 5 years of relevant experience Large Capital project management and execution experience Lean certification Experience with automatic process controls Root cause investigation training/ 6-simga TPM experience Experience with spray-drying technology Experience with equipment maintenance Experience with regulatory inspections and handling deviations Experience working within cross-functional teams. Has experience in change control, budget and project management, including a track record of driving continuous improvement initiatives. Project management track record of delivering projects Data Analysis tools (SQL, JMP, Minitab) , visual management tools (Powerbi, PowerApps) The annual base pay for this position ranges from $97,372 - $146,058. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 22-Dec-2025 Closing Date Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr

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. The Quality Assurance Floor Support Specialist is responsible for providing QA oversight to GMP operations. The role will provide QA support of the start-up and qualification of the Concord site. The QA Floor Support Specialist will demonstrate teamwork by collaborating cross functionally with various levels of the organization. As the project progresses, this role will transition to supporting and escalating issues from manufacturing to the site-based process team for one of the following manufacturing areas: * Formulation and Equipment Preparation Processes * Parenteral Filling (Pre-Filled Syringes) * Automated and Semi-automated Visual Inspection Responsibilities: * Support on-the-floor manufacturing activities with routine presence in the assigned manufacturing area. * Follow good documentation practices and compliance with site procedures. * Review and approve GMP documentation such as electronic batch records, logbooks, etc. * Support creation of Standard Operating Procedures and associated Forms, Tools and Training. * Troubleshoot and provide support to resolve equipment alarms and other issues in quality systems such as Veeva and MES. * Maintain open communications between cross functional teams and area leadership. * Support the execution of inspection readiness activities including support of site self-inspections. * Support project initiatives needed for the project and Quality function. * Communicate any compliance issues associated with the project or site to Quality Management. * Evaluate potential product quality impact for any GMP-related incident and support the investigation and assist with safety investigations. Basic Requirements: * High School diploma or equivalent * Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance * Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills * Strong attention to detail * Ability to work independently with minimal supervision * Proficiency with computer systems including Veeva, MES, Microsoft Programs * Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B paths or at R1 Level. Additional Preferences: * Associates or Bachelors degree in a science, engineering, computer, or pharmaceutical related field of study, preferred * Previous experience with GMP manufacturing equipment prep, formulation, filling, and visual inspection * Previous experience with Manufacturing Execution Systems (MES) or electronic batch records * Previous technical writing experience * Technical aptitude and ability to train and mentor other team members Additional Information: * Ability to work 12 hour shifts onsite on a rotating 2-2-3 schedule (not eligible for remote work) * Overtime and off-shift support may be required * May be required to respond to operational issues outside of core business hours and days * May be subject to post-offer physical and vision exam * Job is exposed to repetitive movements such as: Walking, Sitting, Bending, Twisting * Must have ability to lift 30lbs 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. 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), en Able (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 $28.84 - $46.54 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. #WeAreLilly

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. Responsibilities: During the project phase, Operators (Entry to Lead roles) will support start up activities required to bring the area into service. They will become the experts within their assigned area and educate their team in the proper operation of the facility. The Expert and Lead roles are expected to become the leaders for the equipment and process and will lead the training of new staff. After the project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by, running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Expert and Lead Operators will coordinate daily activities to meet capacity plans while developing their own and our team's capabilities. This position will require travel domestically (3-6 month short term assignments) to collaborate and learn from sites who produce our medicines currently. Key Objectives/Deliverables: * Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients. * Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals. * Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques. * Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor. * Responsible for administering technical training and ensuring all operators are trained to perform tasks. * Operate the equipment and perform activities as required to meet production schedule. * Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs) * Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. * Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls * Key liaison between operations and support functions. Basic Qualifications: * High School Diploma or GED * Ability to effectively communicate (electronically, written and verbal) * Flexibility - the ability to troubleshoot and triage challenges * Computer proficiency (desktop software, MS office). * Must pass a vision exam and be free of color blindness * Must be equivalent to 20/20 correctable close vision acuity Additional Skills/Preferences: * (Senior and Lead roles) Leadership and the ability to train / educate team members * Willingness to travel * Knowledge of current Good Manufacturing Practices (CGMPs) * Previous experience working in operations/pharmaceutical industry * Previous experience with Manufacturing Execution Systems and electronic batch release. * Knowledge of lean manufacturing principles Additional Information * Ability to wear safety equipment (glasses, shoes, gloves, etc) * Will transition to 12-hour day shift in the future (6am to 6pm on 2-2-3 schedule) This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the . For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. 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. 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), en Able (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 $17.30 - $38.08 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. #WeAreLilly

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. Associate Territory Manager -Cardiometabolic Health - SANTA CLARA CA CMH2_171556 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. The Territory Manager will be accountable for account-based selling to health care providers (HCPs) who prescribe and influence the treatment for the disease states represented in the Lilly portfolio. This includes customers in multiple HCP specialties, as well as representatives in key hospital accounts. They will be viewed as a credible expert and resource supporting all medicines and appropriate brand patients. The Territory Manager will be accountable for driving results by embracing Lilly's suite of models: Lilly Selling Model, Lilly Competency Model and Account Management Model to meet the needs of customers through strong execution. Territory Managers will drive consistent ways of working within the Regional Healthcare Market. They will build relationships with key customers to drive utilization and adoption of our medicines for the right patients. Specific responsibilities include the following: BUSINESS OWNERSHIP • Promotes the full portfolio of priority products with multiple HCP specialties. • Understands the marketplace within the territory; evaluates and tailors the territory strategy to grow and own business outcomes. • Navigates the ever-changing healthcare environment and payer landscape to increase understanding of accounts and be able to impact key stakeholders to become trusted partners. • Utilizes appropriate business insight tools, data, and analytics to identify trends, priorities, opportunities, and potential obstacles. • Implements and adopts new technologies, including the integration of AI company-approved tools and other analytical capabilities to streamline customer interactions. • Identifies and advocates for new opportunities to enhance the customer experience. • Models a growth mindset to create positive experiences. SELLING SKILLS / CUSTOMER EXPERIENCE • Embraces and uses the company's selling, competency and account management models to elevate performance and drive results. • Demonstrates high learning agility to understand disease state, marketplace, clinical trials, and product label. • Promotes the BU portfolio by planning for and engaging in patient-centered dialogues with customers. EXECUTION / RESULTS • Promotes across BU-portfolio and across HCP specialties, driving consistent ways of working within the Regional Health Care Market to meet customers' needs. Appropriately, fully utilizes the Virtual Medical Hub. • Achieves targeted sales and execution metrics while adhering to company policies and procedures. • Owns the customer relationship for product promotion, on-label medical questions, and general market access. • Holds self-accountable for results and performance across all accounts, from individual HCPs to large health systems. • Builds and maintains relationships with both internal and external partners to foster trust and create collaborative success. BASIC QUALIFICATIONS • Bachelor's degree. • Professional certification or license required to perform this position if required by a specific state. • Valid US driver's license and acceptable driving record is required. • Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role. ADDITIONAL SKILLS / PREFERENCES • Demonstrated business ownership skills, selling/customer experience skills, and execution/results. • Account based selling experience. Ability to identify and engage staff members in accounts. • Strong learning agility, self-motivated, team focused, and emotionally intelligent. • Bilingual skills as aligned with territory and customer needs. • Residence within 30 miles of the territory boundary. 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. 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), en Able (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 $63,000 - $151,800 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. #WeAreLilly

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. Overview Lilly Catalyze360 is Lilly's comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars-Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly TuneLabs-Catalyze360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning. Lilly ExploR&D is a team of drug discovery and development experts who partner with biotechs from discovery through clinical proof-of-concept, putting Lilly's industry-leading capabilities behind their missions. We provide flexible support-from strategic consulting to full program execution-making it faster, easier, and more capital-efficient for innovators to transform bold science into life-changing medicines. Job Summary The ExploR&D Program Lead (EPL) serves as the single point of accountability for external collaboration projects within Lilly's ExploR&D organization. The role focuses on defining strategy, developing aggressive timelines and budgets, and leading cross-functional teams from Catalyze360 and Lilly Research Laboratories to deliver high-quality results on time and on budget. Reporting within the Catalyze-360 Project Management structure, the EPL leads diverse, cross-functional teams to deliver innovation by pioneering novel science and technologies that advance future medicines and transform R&D collaboration models. Key Responsibilities Team Leadership and Project Management Lead multiple collaboration teams comprised of ExploR&D personnel, LRL subject matter experts and external biotech collaborators. Create a high-performing team with a culture of trust, autonomy, agency, collaboration, and inclusion. Deliver projects ‘on time, on budget', and within scope from discovery/pre-clinical development through clinical proof-of-concept using contemporary project management tools and approaches. Scientific and Technical Leadership Identify and synthesize relevant, technical information from a variety of sources including scientific literature, internal and external subject matter experts, and experimental or trial data to address key questions and guide study design and program strategy. Provide and critically evaluate content within critical documents (e.g., Investigator Brochures, Risk Profiles, Study Protocols, Study Reports, Regulatory and Ethical filings and updates, Investigator updates, etc.). Serve as the ExploR&D scientific leader responsible for rationale, integration of cross-functional data, synthesis of the risk/benefit profile, strategic conclusions, and designs to drive data-driven decision making. Collaboration and Relationship Management: Serve as primary liaison between Lilly and external biotech collaborators, fostering strong relationships, transparent communication and ensuring alignment on project goals. Anticipate and resolve barriers to success by identifying potential roadblocks early, offering innovative solutions, and ensuring that collaboration programs are executed with excellence. Create a ‘partner of choice' experience accounting for partner's goals and priorities, optimizing strategic plans with the spirit of an entrepreneurial drug developer to enable stakeholder decision-making and value-creation. Operational Excellence and Process Improvement: Contribute to diligence and workplan development that optimize outcomes for Lilly and external collaborators. Drive operational excellence in program management by identifying and implementing process improvements that enhance the efficiency and effectiveness of external collaborations. Basic Qualifications/Requirements Education: Advanced graduate degree (PhD, PharmD, or Masters) in a health-related, scientific or engineering field Experience: 10+ years of work experience in the pharmaceutical industry including preclinical-translational sciences and/or clinical drug development across therapeutic modalities such as cell and gene, antibodies, peptides, oligonucleotides, vaccines, and small molecules. Additional Skills/Preferences Fluent Mandarin speaking and writing skills. Prior experience managing external collaborations with proven track record of overseeing complex, cross-functional and external partnering projects. Demonstrated ability to lead and influence teams in a matrixed environment, driving collaboration across diverse functions and geographies. Exceptional verbal and written communication skills, with ability to clearly articulate project goals, strategies, and results to both internal and external stakeholders. Demonstrated ability to anticipate challenges, diagnose root causes, and implement creative solutions that drive project success. Strong intuition for business, with a deep understanding of asset strategy, portfolio management, and the broader pharmaceutical landscape. Practical experience or certification in project management. Intellectual agility to quickly adapt to changing circumstances, learn from past experiences, and apply learnings to new situations. Strong ability to think with a portfolio-level mentality, ensuring that individual program decisions align with the overall goals of ExploR&D and Catalyze360. Additional Information Location: San Francisco, CA Travel up to 25% 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. 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), en Able (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 $187,500 - $275,000 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. #WeAreLilly

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 Description: Receiving, storage, and shipping of raw materials and packaging components in support of the Lilly Concord manufacturing site. Ensure materials are available and on hand for weekly production operations and ensure inventory quantities are accurate. Requirement to handle and process materials in inventory system always following cGMP processes. The position reports to the Warehouse Supervisor. 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. Responsibilities: * Accurate receiving and storage of manufacturing components from outside vendors and other Lilly sites. Shipping of orders to internal and external Lilly customers. * Unloading / loading of materials at docks, receiving of materials, storage of material in appropriate storage zones, preparation and shipping to customer orders, order processing in warehouse inventory system, cycle counting. * Follow all safety requirements and procedures. Routinely inspects area for health and safety issues. Assist with implementation of countermeasures from safety incident investigations. Work with area Supervisor, Warehouse Specialists, and safety representatives to implement safety projects. * Follow all cGMP, and other regulatory requirements. Participate in quality initiatives and audits. Compliance to FDA, EMEA, DEA, OSHA, IDEM, EPA and other applicable regulations. * Meet appropriate goals for performance improvement as defined by area Leadership. * Execute inventory transactions in a timely fashion. * Provide key customers with raw materials and components on time and in full. * Maintain learning plan at 100% current. * Follow and execute policies and procedures impacting warehouse activities. * Maintain a safe work environment, working safely and accountable for supporting all HSE corporate and site goals. * Perform other duties as assigned by the supervisors. Basic Requirements (Education, Experience, Training): We have several levels open for Warehouse technicians which are based on the experience and education you bring. * Minimum education: High School Diploma or GED * Certified to operate assigned powered industrial trucks or ability to obtain certification within 3 months of employment start. Additional Preferences: * Ability to effectively communicate (electronically, written and verbal) * Flexibility - the ability to troubleshoot and triage challenges. * Ability to use Computer tools (desktop, MS Office) and electronic tools (Scan guns and tablets). * Ability to pick-up / move up to 50-pound containers. * Strong interpersonal and communication skills * Demonstrated ability to work as a team across various areas. * Solid understanding of quality and corporate policies * Exposure to SAP/EWM preferred. * Solid understanding of the importance of and basic requirements of regulatory agencies such as the FDA, EMEA, OSHA and EPA. * Demonstrated solid judgment and initiative. * Ability to use technology tools such as Scan guns, tablets and laptops strongly preferred. * Enthusiastic, positive attitude, flexible and willing to work overtime. * Proactive and self-motivated to support team initiatives and in solving business problems. * Ability to perform multiple tasks at the same time and make decisions regarding prioritization. * Previous experience with materials handling and inventory management systems. * Previous warehouse/logistics experience in a cGMP environment. Additional Information: * Ability to work overtime, weekends, and off shifts as needed. * Tasks may require handling hazardous materials following safety procedures. This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. 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. 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), en Able (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 $17.30 - $38.08 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. #WeAreLilly

A global biopharmaceutical company in California is seeking a Global Study Director to oversee groundbreaking clinical studies. You'll lead cross-functional teams, manage project deliverables, timelines, and ensure compliance with regulatory standards. The ideal candidate will have extensive experience in clinical trials, particularly in hematology and oncology, with strong project management skills. This role offers a competitive salary and benefits, emphasizing collaboration and innovation within a diverse workplace. #J-18808-Ljbffr

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. We are a leading biopharma company dedicated to advancing therapies that extend healthspan and combat age-related diseases. We are seeking a highly motivated scientist to join our research team to spearhead efforts focused on immune aging and rejuvenation. In this role, you will drive cutting-edge research to identify and develop novel interventions, using any modality that is appropriate for the indication, to restore immune homeostasis, mitigate inflammaging and improve organ function. This position offers the opportunity to pioneer transformative therapies to ameliorate prevalent and debilitating conditions in the aging population, with a focus grounded in Immunology. The individual will have the opportunity to build and manage a research team supporting immune-aging projects and to provide cross-functional leadership through larger collaborative efforts. Responsibilities * Design and execute preclinical studies to investigate mechanisms underlying immune senescence, including but not limited to age-related hematopoietic stem cell (HSC) dysfunction, telomere attrition, senescence-associated phenotypes, and T-cell exhaustion. * Develop rejuvenation/reprogramming strategies to revitalize hemopoietic and non-immune, parenchymal cells of interest in immune and age-related disorders. * Utilize advanced techniques in cytometry, 'omics and hi-dimensional datasets to identify targetable nodes for intervention. Use appropriate in vitro, in vivo and ex vivo models to assess immune aging phenotypes of interest. * Collaborate with stakeholders in Immunology and other therapeutic areas to cross-functionally lead and develop research findings into future clinical candidates. * Prepare and present research findings at internal meetings, scientific conferences, and in peer-reviewed publications. * Stay abreast of emerging advances in the field to inform strategic decisions and help assess external opportunities as needed. * Contribute to IP filings, and regulatory documentation as needed. * Recruit and train a small team to scale research efforts. Basic Qualifications/Requirements: * PhD in Immunology, Cell Biology, Developmental Biology, or a related field; Postdoctoral experience in aging biology or rejuvenation is required. * 5+ years of hands-on research experience in academia, biotech, or pharma, with a proven track record related to immune aging/senescence research. Additional Skills/Preferences: * Demonstrated expertise in molecular mechanisms of immune senescence, including inflammaging, stem cell exhaustion, and therapeutic interventions * Familiarity with landscape of immune aging research activities including but not limited to academic labs, biotechnology companies, and large pharma. * Strong publication record in high-impact journals with first- or senior-author contributions. * Proficiency in experimental design, data analysis and statistical methods. * Excellent communication skills, with the ability to convey complex scientific concepts to diverse audiences. * Experience with in vivo models of aging (e.g., progeroid mice, humanized models) and translational strategies for rejuvenation therapies. * Advanced knowledge of stem cell rejuvenation techniques, epigenetic reprogramming and delivery systems. * Prior experience leading a cross-functional team and/or managing others. * Understanding of the unique regulatory hurdles in regeneration and aging-related therapeutics. Additional Information: Travel: Estimated ~20% Work Environment: Position is based in South San Francisco, CA 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. 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), en Able (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 $163,500 - $281,600 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. #WeAreLilly

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. Quick Benefits Overview: * Medical, Dental, Vision, Prescription benefits are effective on your first day of employment * Paid vacation- starting annually at 120 hours (prorated based on start date) * Shift Bonus for Weekend hours * Sign-on bonus For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. Responsibilities: The focus of the Maintenance Technician - Night Shift is to provide maintenance expertise to service, repair, and maintain process and utility other pharmaceutical manufacturing equipment currently in service. The Maintenance Technician - Night Shift is expected to understand the needs and requirements of the customer (Operations); must be able to work effectively with customers, handle customer questions with tact and understanding while displaying good customer service. Key Objectives/Deliverables: * This role is expected to improve equipment uptime, line efficiency, and increase overall equipment effectiveness in a production environment by condition monitoring, troubleshooting, and assisting in engineering changes. * Must possess a good mechanical aptitude to troubleshoot and repair equipment while, following departmental rules and regulations. * Must be willing to work with safety as a primary focus and abide by applicable safety procedures and practices. * Troubleshoot the root causes of machine problems (e.g., excessive vibration or temperature, bearing failures, abnormal noises, and poor performance). * Perform repairs and overhaul equipment (e.g., gear boxes, pumps, blowers, fans and drives) to include disassembly, setting tolerances, aligning, resetting timing (e.g., air compressors, vacuum pumps) * Setup equipment to design specifications (e.g., timing, leveling, alignment) * Operate precision alignment equipment (e.g., Roma-align, lasers, etc.) * Must have the ability to quickly and accurately diagnose the root cause of a problem and implement the proper corrective actions to minimize downtime. * Must accurately document the actions taken to repair the equipment in the CMMS program. * Willing to assist in areas outside of their primary responsibility and learn other skills, as required Basic Qualifications: * High school diploma/GED * Minimum 2 Years of Maintenance * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position * Must satisfy background check and drug screening requirements. Additional Skills/Preferences: * Must be able to speak, read and write English at a sufficient level to communicate technical and business information effectively. * Must be able to effectively use business software programs, such as, Maximo, Microsoft Outlook, Microsoft Office Suite and other required software programs. * Must be able to effectively work in a team environment. * Physical considerations include the ability to work with or around equipment, climb ladders and stairs and use PPE (Personal Protective Equipment). He/she may be exposed to harsh weather conditions as part of the job. * Good, all-around hands-on experience with repair of equipment. * Use basic trouble shooting equipment such as multi-meters, calipers ect. Additional Information: * Overtime may be required during shutdowns, emergency situations, or periods of heavy workloads. * The Maintenance Technician - Night Shift will work in and around potentially dangerous and hazardous equipment, powders, liquids and gases. Safety is paramount for this position. * Night shift role. Will transition to a night shift 12-hr 2-2-3 schedule in the future. For the training period, it will be a day shift role. 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. 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), en Able (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 $21.27 - $41.25 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. #WeAreLilly

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 unites caring with discovery to create medicines that make life better for people around the world. Lilly is a Fortune 500 company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and technical organization from the ground up. The Principal Scientist/Engineer - Cleaning Validation/Sterilization Validation - Technical Services / Manufacturing Science (TS/MS) role is a technical position that develops and supports the validation of production equipment and systems and provides technical leadership regarding temperature mapping, cleaning and sterilization validation strategies. Primary objectives include the start-up and compliant manufacturing of products, particularly as it relates to development and implementation of validation strategies, including sterilization validation, cleaning validation, filter validation, and other related activities. The scope of the role includes device assembly, packaging, and syringe filling operations for commercially manufactured products targeted for transfer to the Concord site. Key Objectives / Deliverables: * Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. * Provide technical support for all start-up activities related to temperature mapping, cleaning and sterilization programs. * Development and execution of cleaning and sterilization strategies that focus on the validation of production equipment and systems (e.g., tanks, component/parts washer, autoclaves, filling isolators, etc). * Support periodic requalification activities for production equipment and systems. * Author and support the execution of validation protocols and reports. * Provide technical guidance to the Process Team for cleaning and sterilization processes. * Lead or provide technical support for root cause investigations related to cleaning, sterilization, and other related activities. * Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements. * Coordinate with cross-functional process teams for the implementation of projects identified to improve productivity, quality, or continuous improvement of cleaning and sterilization processes. * Participate or provide guidance for equipment cleaning and sterilization programs during internal and external audits, including regulatory inspections, as needed. * Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc. * 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 cleaning and sterilization interface external to the Concord 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. Minimum Requirements: * BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline * 3+ years experience supporting cGMP manufacturing (specifically within validation, engineering, technical services/MSAT, operations, quality assurance, etc.) Additional Preferences: * In depth knowledge of parenteral drug product manufacturing * Experience executing equipment qualification, cleaning validation, and sterilization validation * 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 Concord 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. 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), en Able (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. #WeAreLilly

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. 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: For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don't want to miss! Responsibilities: The Automation Technician - Night Shift is responsible for equipment performance, providing first-line support to production processes, as well as supporting area engineering initiatives, process improvements, project implementation, performing mechanical repairs and adjustments, and executing routine PMs. This position will require the development of expertise in production processes, commissioning, qualification, and validation requirements and equipment-specific code and/or control system technologies. The Automation Technician - Night Shift will help ensure that equipment is maintained in a qualified state, can be operated safely, and maintenance is properly performed on the systems. Key Objectives/Deliverables: * Assure that operational and maintenance procedures and practices reflect safety concerns. * Perform activities in accordance with cGMPs and applicable procedures. * Must possess a good mechanical aptitude to troubleshoot and repair equipment while, following departmental rules and regulations. * Troubleshoot the root causes of machine problems (e.g., excessive vibration or temperature, bearing failures, abnormal noises, and poor performance). * Identify opportunities to improve quality using equipment performance data and by assuring maintenance is performed appropriately. * Setup equipment to design specifications (e.g., timing, leveling, alignment) * Operate precision alignment equipment (e.g., Roma-align, lasers, etc.) * Must have the ability to quickly and accurately diagnose the root cause of a problem and implement the proper corrective actions to minimize downtime. * Must accurately document the actions taken to repair the equipment in the CMMS program. * Willing to assist in areas outside of their primary responsibility and learn other skills, as required * Experience in instrumentation, PLC and/or HMI programming. * Effectively communicate with all levels to ensure all projects and repairs are well planned and coordinated with minimal disruption to that area involved. * Working with the process team, including engineers and operations personnel, participating in and sometimes leading the development of equipment design, procedures, engineering studies, and maintenance practices that will enable the process to operate as required. * Seek out and identify opportunities to improve equipment operational effectiveness and reliability. * Must be able to effectively use business software programs, such as, Maximo, Microsoft Outlook, Microsoft Office Suite etc. * Provide technical support to engineering in: * Investigating and resolving issues that create production delays * Transferring knowledge of equipment capabilities and operational techniques to operators, engineering, and maintenance. * Implementing tools for operations and engineering to learn and work more proficiently. * Create maintenance action plans as needed to support maintenance and troubleshooting activities. * Participate in periodic reviews of equipment state. * Plan and execute small projects for process or equipment improvements or changes. Minimum Requirements: * High school diploma/GED * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position * Must satisfy background check and drug screening requirements. Additional Preferences: * Demonstrated ability to work safely in a participative environment. * Experience in a GMP manufacturing environment. * Studio 5000 and Factory talk view SE programming experience. * Demonstrated proficiency with Microsoft Word and Excel; proficient at typing and writing technical documents. * Demonstrated ability to work independently with strong organizational skills and attention to detail and ability to adapt to rapidly changing priorities * Demonstrated strong interpersonal skills and communications skills with a customer service attitude. * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. * Previous experience with highly automated equipment * Experience with B&R platform is a plus. * Knowledge of Parenteral / Packaging equipment and manufacturing operations * Experience with Maximo or similar computerized maintenance management system. Other Information: * Overtime may be required during shutdowns, emergency situations, or periods of heavy workloads. * The Automation Technician - Night Shift will work in and around potentially dangerous and hazardous equipment, powders, liquids and gases. Safety is paramount for this position. * Day Shift role currently. Will transition to a Night Shift 12-hr 2-2-3 schedule in the future. This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the . For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. 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. 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), en Able (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 $21.27 - $46.88 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. #WeAreLilly 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. 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), en Able (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 $21.27 - $41.25 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. #WeAreLilly

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. The Deviation Mentor plays a critical role within the Quality Assurance (QA) organization, providing expertise, guidance, and training for deviation and laboratory investigations. This position is responsible for strengthening investigation quality, supporting inspection readiness, and leading select complex investigations. Key Responsibilities Deviation Investigation Leadership * Guide and coach investigators in conducting high-quality deviation investigations, including root cause analysis, impact assessment, and technical documentation. * Support reviewers and approvers by providing subject matter expertise in investigation practices. * Lead complex or high‑risk investigations as needed. * Participate in or facilitate deviation review boards, ensuring thorough evaluations for both pre‑approval and post‑approval stages. * Contribute to deviation trending, monitoring, and reporting activities. * Design and deliver training programs focused on investigation skills and deviation management. * Develop and maintain site‑specific metrics related to deviations and investigations. Qualifications * Bachelor's or Master's degree in a scientific or technical discipline (e.g., Chemistry, Biology, Microbiology, Engineering). * 5+ years of experience in pharmaceutical manufacturing operations; parenteral experience preferred. * Strong technical writing and analytical problem‑solving capabilities. * Excellent communication skills with the ability to provide clear, constructive feedback. * Demonstrated ability to support collaboration, continuous improvement, and high‑quality documentation practices. * Solid understanding of cGMPs, quality systems, and regulatory expectations. Preferred Attributes * 7+ years of QA experience in pharmaceutical or medical device industries. * Experience with deviation management systems such as Veeva or TrackWise. * Proficiency in CAPA, change control, and product complaint processes. * Hands‑on experience supporting or preparing for regulatory inspections. * Exposure to parenteral product materials and processes. * Proven ability to influence and lead cross‑functional teams or project implementations. Additional Information * Some off‑hours or weekend coverage may be required to support 24/7 operations. * Travel up to 10%, primarily domestic. * Primary work location: Concord site (on‑site presence expected). 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. 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), en Able (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 $63,000 - $162,800 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. #WeAreLilly

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. Responsibilities: The Scientist - TSMS PAR will initially focus on the delivery of parenteral operations, specifically regarding technical transfer and process validation. TSMS PAR Scientists will support one of either formulation, filling, or visual inspection (VI), although may support multiple areas during start-up phase. Upon the start of commercial production, this role's objectives include maintaining the validated state of applicable processes, establishing and monitoring metrics/methods to ensure a state of capability and control, harmonization of control strategies across process teams, evaluate process improvement, and serving as an escalation point for day-to-day operations issues. The role will also author and execute protocols as well as conduct root cause investigations. The principal role is a position that develops and implements a technical agenda and is responsible for providing technical leadership for the Parenteral Process Team. The principal role expected to serve as a mentor within the TSMS team and engage in upstream and external to site activities related to parenteral manufacturing. Key Objectives/Deliverables: * Support the assigned Process Team (formulation, filling, or VI) as TSMS representative. • (Associate/Senior) Serve as floor-level support and technical interface for manufacturing components, equipment, and operations for the TSMS team. * Represent Concord TSMS team for internal and external communications on a regular basis * Lead risk management activities as it pertains to product/process * Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues * Prepare and Review or approve, as required, relevant technical documents such as: Annual Product Reviews, Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, PFMEAs, etc. * Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability * Identify opportunities and lead technical projects to improve process control and/or productivity * Serve as interface with upstream suppliers and parenteral product networks * Drive stability strategy for Concord products * Provide Audit support as needed * Identify opportunities and participate in projects to improve process control and/or productivity Basic Qualifications: * Bachelor's degree or higher an engineering, packaging science, or related field Additional Skills/Preferences: * Pharmaceutical and/or medical device manufacturing experience * Root Cause Investigation Experience * Proficiency with computer systems including Microsoft Office products, Veeva Vault, TrackWise, electronic batch records, and SAP * Demonstrated successful leadership of cross-functional teams * Strong interpersonal and teamwork skills * Strong self-management and organizational skills Additional Information: * Role is Monday through Friday. 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. 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. 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), en Able (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. #WeAreLilly

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 entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: * Assess differences in current sterility assurance programs across the sites and drive harmonization * Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. * Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. * Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. * Building, maintaining, and growing capability across the organization in the sterility assurance space * Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. * Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. * Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. * Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. * Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. * Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: * BS Degree required. * MS/PhD in a biological science preferred. * 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. * 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. * Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) * 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 mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance * Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space * Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance * Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. * Strong capability to influence personnel and management across the organization * Close interaction with quality to enable internal audits that identify risks * Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: * Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. 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). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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. 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. 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), en Able (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 $133,500 - $246,400 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. #WeAreLilly

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. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, 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 HVAC Engineer is the site Subject Matter Expert (SME) for site HVAC (GMP and non GMP) and the ancillary systems associated within the facilities. During the project phase, the HVAC Engineer will be a key player in the cross functional project team in charge of the construction, commissioning, qualification, start-up and operational readiness of all HVAC systems. During the day-to-day operation, the HVAC Engineer will be responsible for effectively, reliably, and cost effectively operating the site's HVAC (GMP and non-GMP) and ancillary systems associated within the facilities, maintaining all these systems in a state of compliance, in-control, and fit for use, capable of meeting all site needs. The HVAC Engineer will also be responsible for driving continuous improvement initiatives and local capital investment. Responsibilities * Be the SME with a deep technical expertise in all systems under his/her responsibility (GMP and non-GMP HVAC and ancillary systems associated within their facilities), understanding their applications in pharmaceutical manufacturing, understanding flow charts and process parameters, and awareness of industry trends. * Ensure the assigned processes are in alignment with the Industry and Lilly Standards * Support risk assessment exercises using the different tools available (e.g. FMEA) * Participate as required in teams, committees, or other groups and/or individually to achieve the departmental, site and/or company goals Initial project asset delivery phase and future local capital investment: * Lead or participate in projects/changes for all the systems under his/her responsibility including Design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects. * Develop the proper documentation (URs, Specification, test cases, etc..) to demonstrate that systems are properly installed, qualified and started up and that remains in a controlled state * Contribute to the process resource assessment, capital plans, expense budgets, and prioritize appropriate Daily Support to operations: * Monitor utility systems and maintain KPI's to assure that they are operating properly, in compliance with requirements. * Provide written instructions for the proper way to operate and maintain the equipment and process to assure that the system operates within the controlled parameters * Implement efficient and effective maintenance and reliability techniques, * Apply problem solving skills by leading equipment failures troubleshooting, demonstrating RCA lead investigator proficiency and guide operations personnel in the resolution of process issues. * Provide customer consultation and notifications on issues that involve utilities areas assigned * Assure that all necessary items are identified on the proper tracking systems, and make sure that items are completed by the required date * Provide technical assistance as necessary to maintenance, and operations personnel * Support internal and external inspections and investigations (including Quality and HSE) * Maintain efficient communications with appropriate site customer groups * Proficiency with the Trackwise and CAPA systems Basic Requirements: * Education Requirements: Bachelor's degree in Engineering (prefer ME, EE, Chem E). * Technical experience of HVAC and Utilities Additional Preferences: * Demonstrated office software skills (Word, Excel, PowerPoint, Outlook, UMS, data historian) and collaboration sites * Excellent interpersonal, written and verbal communication skills * Knowledge of cGMP * Demonstrated high level of understanding of engineering concepts, 1st principles, and engineering functional standards * Strong technical aptitude and ability to train and mentor others * Previous start up experience * Engineering experience in the pharmaceutical industry * Previous equipment commissioning experience * Engineering experience with manufacturing plant utilities * Project management experience * Experience with maintenance and computerized maintenance management systems (CMMS) * Previous experience with deviation and change management systems including Trackwise 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. 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), en Able (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. #WeAreLilly

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 For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. Position Description Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site. If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity! During the project phase, the Parenteral (PAR) Operators (Entry to Expert roles) will support start up activities required to bring the area into service which may include formulation, aseptic isolator barrier filling, and visual inspection. They will become the experts within their assigned area and educate their team in the proper operation of the facility. After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Operators will support daily activities to meet capacity plans while developing their own and our team's capabilities. As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles. Key Values / Objectives Integrity * Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients. * Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals. * Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques. Excellence * Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor. * Responsible for administering technical training and ensuring all operators are trained to perform tasks. * Operate the equipment and perform activities as required to meet production schedule. * Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs) * Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. Respect for People * Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas. * Key liaison between operations and support functions. Basic Qualifications/Requirements: Time Commitments and Work Authorization * Minimum education: High School Diploma or GED * A valid drivers license * Must Pass a "fitness for duty" physical exam * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. * Must pass a vision exam and be free of color blindness * Must be equivalent to 20/20 correctable close vision acuity * Must be able to work a 2-2-3 schedule Additional skills/preferences: Experience with, completion of, or understanding of: * We have several levels open for Operator which are based on the experience and education you bring. * Ability to work overtime as required * Ability to wear safety equipment (glasses, shoes, gloves, etc) * Ability to work and gown in a cleanroom (Grade C, ISO 8) environment. * Ability to participate in professional development opportunities (team coursework such as classes through RCCC) * Ability to effectively communicate (electronically, written and verbal) * Flexibility - the ability to troubleshoot and triage challenges * Computer proficiency (desktop software, MS office). * Leadership and the ability to train / educate team members * STEM degree or certifications * Aseptic filling, single use assemblies, isolator technology. * Automated, semi-automated, and/or manual inspection. * Knowledge of current Good Manufacturing Practices (CGMPs) * Experience in operations or manufacturing environments. * Pharmaceutical, medical device or food processing industries * Manufacturing Execution Systems and electronic batch release. * Continuous improvement (Lean, Six Sigma methodologies) * Highly automated equipment (inspection, packaging, filling, assembly, etc) * SAP, Electronic Batch Records 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. 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), en Able (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 $17.30 - $34.38 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. #WeAreLilly

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 Lilly Catalyze360 is a comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars-Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly TuneLab-Catalyze360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning. Job Summary The Manager of IT Contracts & Business Operations is responsible for negotiating fee-for-service IT contracts across the Lilly Catalyze360 organization. This role requires a proactive, self-driven individual with deep expertise in AI technologies and IT infrastructure and services who can navigate technical complexity while securing favorable commercial terms. The ideal candidate stays current on emerging AI/ML and other IT trends, understands their practical business applications, and can translate that knowledge into well-structured agreements that protect Lilly's interests while enabling innovation. This individual will provide contract matter expertise for IT engagements and collaborate with legal, finance, and technical stakeholders to structure agreements that balance business needs, risk mitigation, and cost optimization. The role has potential to expand into managing Business Operations IT pilots and systems implementations as well. Key Responsibilities Negotiate complex contracts for a variety of Catalyze360 IT needs, including IT professional services, software license, software development, service level, SaaS/PaaS/IaaS, and AI/ML agreements as well as associated change orders Serve as the primary interface between Business Operations and IT/business stakeholders, translating technical requirements into contractual terms and managing vendor relationships to ensure alignment with business objectives Collaborate cross functionally with IT/business, legal, finance, and other stakeholders to structure IT agreements that balance business needs, risk mitigation, and cost optimization Identify and mitigate business risks throughout the contracting process, including protecting sensitive confidential information and privacy Manage multiple concurrent IT contract negotiations while monitoring performance and vendor compliance Potential to oversee implementation, configuration, and ongoing management of Contract Lifecycle Management (CLM) and other systems to optimize contracting processes and ensure compliance Potential to structure and oversee Business Operations pilot programs and promote adoption of successful pilot solutions Minimum Requirements Education: Bachelor's degree from an accredited college or university Experience: 3+ years of experience with a variety of IT contract negotiations (including IT professional services, software license, software development, service level, and SaaS agreements) in the biotechnology/ pharmaceutical or other regulated industry Work Authorization: Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role. Additional Skills/Preferences Experience Demonstrated experience negotiating contracts for AI/ML applications across drug discovery and development Prior experience designing and coordinating pilot programs, proof-of-concept initiatives, or technology evaluations Experience with Contract Lifecycle Management (CLM) system implementation and optimization Skills Strong understanding of and fluency with IT architecture, cloud infrastructure, software development lifecycle, and enterprise technology solutions Advanced expertise in Intellectual Property frameworks for AI/ML efforts Deep understanding of IT security requirements, compliance frameworks including privacy regulations, and data governance in regulated industries Ability to work through competing priorities with speed and agility in a highly collaborative environment with diverse stakeholders Excellent communication skills with ability to engage diverse stakeholders including technical, legal, and finance team members Strong analytical and problem-solving capabilities with strategic thinking and an entrepreneurial mindset Additional Information Travel up to 10% US as needed for stakeholder engagement and vendor meetings. 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. 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), en Able (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 $69,000 - $165,000 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. #WeAreLilly