#LI-Remote The Associate Director, Access & Reimbursement, NPS (Novartis Patient Support) Cardiovascular, San Jose, CA is a remote & field-based role that covers the following, but not limited to: Fresno, Salinas, Stockton, Tracy, Clovis, San Mateo, Palo Alto & San Jose, CA. Associate must reside within territory, or within a reasonable daily commuting distance of 60 miles from territory border.
The Associate Director, Access & Reimbursement (ADAR) is a field-based role that proactively provides in person (or virtual as needed) education to defined accounts within their assigned geographies on a wide range of access and reimbursement topics and needs (see below) in support of aligned product(s) strategy. ADARs primarily focus on accounts with increased process and workflow complexity, typically including centralized and decentralized systems of care, integrated delivery networks, academic medical institutions, large multi-provider specialty practices, and alternate sites of care.
ADARs will serve as the patient access and reimbursement lead in business-to-business conversations with account executives. The ADAR role is responsible for managing the pull-through of access and reimbursement strategy and downstream operations within their aligned accounts. ADARs are expected to have deep expertise in communicating requirements and addressing barriers associated with local payer policy coverage, multi-channel acquisition pathways, billing and coding education (as needed), claims processing, reimbursement, and integration of manufacturer support programs into a range of account workflows. ADAR will continually need to demonstrate a keen ability to problem solve and manage multiple projects.
ADARs partner closely with other Novartis Pharmaceuticals Corporation (NPC) field associates, including Customer Engagement (Sales) and Market Access, representing NPC with the highest integrity in accordance with NPC Values and Behaviors. ADARs will also be required to coordinate and communicate cross-functionally within NPC (e.g., Patient Support Center, Customer Engagement, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management, and other applicable third party affiliates).
Job Description
Key Responsibilities:
Interact with large, complex accounts to support patient access within their aligned therapeutic area product(s), proactively provide face-to-face education on programs to providers and staff in order to support integration of those products into office processes and workflows.
Address customer questions for issues related to NPC policies on therapeutic area products ordering, payment, inventorying, and product returns & replacement in offices.
Work with key members of therapeutic area offices (e.g., executives, providers, administrators, billing and coding staff, claims departments, revenue cycle managers) in order to appropriately support patient access to products.
Ability to analyze problems and offer solutions. Understand specifics and support questions associated with patient reimbursement and provide support on reimbursement issues with third party payers at the provider-level. Analyze account reimbursement issues (as needed). Identifies trends at a local, regional and national level and partner with purpose internally and externally to support patient access to Novartis medicines
Supports pull through on local coverage decisions to enable meaningful patient access within the system. Proactively communicate policy changes or issues that could potentially affect other departments.
Accountable for informing customers on NVS-sponsored patient support programs to help enable patients starting and staying on therapy (i.e., Co-pay).
Maintain expertise in regional and local access landscape, anticipating changes in the healthcare landscape, and act as their aligned therapeutic area product(s) reimbursement expert (as needed).
Interface with Patient Support Center (hub) and Access & Reimbursement Managers on important matters related to patient case management, including tracking cases, issue resolution, reimbursement support, and appropriate office staff education.
Collaborate with aligned cross-functional associates within NPC (see above) to share insights on customer needs and barriers for their aligned therapeutic area product(s) related to access and reimbursement.
Maintain a deep understanding of NPC policies and requirements and perform all responsibilities with integrity and in a manner consistent with company guidance and prescribed Values and Behaviors. Handle Patient Identifiable Information (PII) appropriately (understand and ensure compliance with HIPAA and other privacy laws and regulations and internal Company compliance guidelines).
Responsible for identifying and reporting adverse events via the established Novartis systems as per applicable processes.
Buy and Bill Specific
Assess access situation within the assigned geography and develop appropriate Plan of Action (POA). Communicate POA to appropriate personnel.
Responsible for educating HCPs using approved materials regarding acquisition pathways for Novartis products. Educate on buy-and-bill end-to-end processes, workflows, and facility pull-through in complex accounts, including scenarios of centralized and decentralized acquisition, and use of alternative channels such as white bagging, clear bagging, brown bagging, and alternate site of care for administration.
Educates relevant stakeholders on logistics related to ordering, payment, inventory, and product returns & replacement.
Analyze reimbursement issues, anticipating changes in the healthcare landscape, and act as the designated reimbursement expert for offices and field teams.
Accountable for engagement with non-prescribers in regards to Novartis medicines, for example pharmacy, system leadership, financial counselors, office administrators, revenue cycle managers, etc.
What You'll Bring to the Role:
Education: Bachelor's Degree required. Business and/or biological science education preferred. Advanced degree preferred.
Essential Requirements:
5+ Years of experience in pharmaceuticals / biotech industry focused in Patient Services, Market Access, Sales, and/or account management. With 2 of those years being in a Patient Services practice support role for a specialty product(s).
Experience working with highly complex practices and/or health systems to establish access and acquisition pathways.
Strategic account management experience using a proactive approach to anticipate access hurdles impacting accounts and patient access.
Deep expertise and experience integrating manufacturer-sponsored patient support programs.
Experience with specialty products acquired through Specialty Pharmacy networks
Knowledge of reimbursement pathways (specialty pharmacy, buy-and-bill, retail)
Possess a strong understanding of Commercial payers, Medicare plans and state Medicaid in geographic region.
Must live within assigned territory.
Ability to travel and cover geography, at least 50% travel required, based on geography and territory / targeting make up.
Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated.
Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role.
The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.
Desirable Requirements
Experience leading and delivering presentations to C-level account executives.
Strong ability to work cross functionally with such functions as Field Sales, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management and applicable third-party affiliates.
Expertise in therapeutic area practice dynamics and common reimbursement and product program support-related needs.
Strong capabilities in the areas of customer focus, collaboration, business acumen, communication, and presentation skills.
This position requires significant use of a company provided vehicle and maintaining good driving record
This is a field-based customer engaging position
Control business expenses related to field activities (i.e. travel, customer meetings) and provide timely expense reports to manager.
Compensation Summary:
The salary for this position is expected to range between $160,300 and $297,700 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.
COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to **********************************
For Field Roles with a Dedicated Training Period:
The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$160,300.00 - $297,700.00
Skills Desired
Access And Reimbursement Strategy, Agility, Analytical Skill, Analytical Thinking, Cross-Functional Collaboration, Customer-Centric Mindset, Employee Development, Finance, Go-To-Market Strategy, Healthcare Sector Understanding, Health Economics, Health Policy, Health Technology Assessment (HTA), Innovation, Inspirational Leadership, Market Access Strategy, Negotiation Skills, People Management, Process Management, Public Affairs, Real World Evidence (RWE), Regulatory Compliance, Risk Management, Value Propositions, Waterfall Model
$96k-120k yearly est. Auto-Apply 49d ago
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A leading biotechnology company is seeking a Senior Medical Science Liaison focused on Nephrology programs. This role entails establishing relationships with healthcare professionals, executing the medical affairs strategy, and delivering scientific information. Candidates should have a minimum of 3-4 years in a similar position, an advanced life sciences degree, and strong communication skills. The position offers a competitive salary and robust benefits, reflecting the company's commitment to employee growth and well-being.
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Global Study Director, Cell Therapy Trials
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San Jose, CA job
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.
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$126k-161k yearly est. 6d ago
Senior Engineer, Process Engineering
Astrazeneca 4.6
Redwood City, CA job
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.
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A global healthcare company seeks a Director of Product Brand Marketing for their Robotics & Digital Solutions organization. The position, based in Santa Clara, CA or Cincinnati, OH, involves leading the development of a brand narrative and multi-channel communication strategy for the Ottava Surgical Robotics Portfolio. The ideal candidate has a Bachelor's degree, extensive experience in brand management, and a proven ability in cross-functional collaboration, along with strong communication and leadership skills. This role may require travel and offers a competitive salary.
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$120k-153k yearly est. 3d ago
ExploR&D Clinical Program Lead
Eli Lilly and Company 4.6
San Francisco, CA job
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
$187.5k-275k yearly Auto-Apply 60d+ ago
Operator, Device Assembly and Packaging - Night Shift
Eli Lilly and Company 4.6
Concord, CA job
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.
Operator, Medical Device Assembly and Packaging - Night Shift
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 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. Our 35,000 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 and embody our company values of Integrity, Excellence, and Respect for People
Position Overview
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.
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
* (Lead role) Assist Supervisor in development and performance evaluations of shift operators. Act as backup for Supervisor.
* 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).
Additional Skills/Preferences:
* (Senior and Lead roles) Leadership and the ability to train / educate team members
* 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)
* Ability to work 12-hour shifts on days (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.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources (Lilly_Recruiting_************************** ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups includes Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
#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
$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
$35k-42k yearly est. Auto-Apply 60d+ ago
Principal Scientist, Biopharma Innovation & Digitalization
Boehringer Ingelheim GmbH 4.6
Fremont, CA job
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.
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$134k-180k yearly est. 3d ago
Associate - Quality Assurance - Deviation Mentor
Eli Lilly and Company 4.6
Concord, CA job
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.
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$63k-162.8k yearly Auto-Apply 4d ago
Head of Clinical Engineering, Robotics & Digital Solutions
Johnson & Johnson 4.7
Santa Clara, CA job
A leading healthcare solutions company in Santa Clara seeks a Head of Clinical Engineering for its Robotics and Digital Solutions group. This role requires an experienced leader who will build a high-performing team and influence technical strategies in the MedTech field. The ideal candidate has significant clinical/technical experience, strong leadership abilities, and a passion for enhancing healthcare through innovation. The position offers a competitive salary and opportunities for professional growth.
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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.
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$66k-171.6k yearly Auto-Apply 60d+ ago
Associate Director, Statistics
Allergan 4.8
San Francisco, CA job
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
TheAssociate Director, Statistics - Oncology provides statistical leadership for clinical development and life‑cycle management strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs (GMA). The Associate Director works in partnership with experts in multiple disciplines to advance medicines to our patients.
This role will work a hybrid schedule in one of the AbbVie locations:
Lake County, IL
South San Francisco, CA
Responsibilities
Provide statistical support for one or more clinical development projects through own efforts or those of a team. Lead/develop statistical strategy for project development and regulatory submission.
Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans.
Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, and GMA, etc.) to create development strategies for assigned projects.
Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately.
Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.
Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing collaborators. Build external scientific connections which foster professional development and promote the reputation of the Statistics Department.
Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software to ensure compliance with SOPs and regulatory requirements.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
Qualifications
MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly related field.
High degree of technical competence and excellent communication skills, both oral and written.
Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others.
Able to manage project timeline and quality of deliverables.
Able to build strong relationship with peers and cross‑functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo.
Have strong leadership skills and experience in working/managing cross‑cultural or overseas teams.
Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life‑cycle management in the regulated environment.
(SSG) Experience leading safety‑related projects (eg, ISS, benefit‑risk assessment, signal detection).
(GMA Stat) Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Knowledge of methodologies for confounding control and bias minimization in observational studies preferred.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short‑term incentive programs.
This job is eligible to participate in our long‑term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit *************************************************************************
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************
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$146k-190k yearly est. 5d ago
Director - Immunology Research
Eli Lilly and Company 4.6
San Francisco, CA job
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.
Purpose
Lilly TuneLab is an AI-powered drug discovery platform that provides biotech companies with access to machine learning models trained on Lilly's extensive proprietary pharmaceutical research data. Through federated learning, the platform enables Lilly to build models on broad, diverse datasets from across the biotech ecosystem while preserving partner data privacy and competitive advantages. This collaborative approach accelerates drug discovery by creating continuously improving AI models that benefit both Lilly and our biotech partners.
The Machine Learning Scientist/Sr Scientist, Federated Benchmarking & Validation Engineering plays an essential role within the TuneLab platform, responsible for identifying, assessing, and implementing cutting-edge algorithmic solutions that leverage diverse datasets while ensuring data privacy and security for our biotech partners. This position requires comprehensive knowledge in small molecule drug development, ADME/Tox, antibody engineering, and/or genetic medicine, combined with expertise in data science and statistical analysis to develop sophisticated models utilizing federated learning. This position will be instrumental in advancing both Lilly's pipeline and our partners' drug discovery efforts by designing critical algorithms and workflows that expedite the creation of transformative therapies.
This role centers on constructing robust validation frameworks for federated models, creating privacy-preserving test sets across partner datasets, establishing standardized benchmarks against public datasets, and ensuring model reproducibility and generalization in diverse deployment scenarios.
Key Responsibilities
* Federated Test Set Design: Architect and implement privacy-preserving protocols for constructing representative test sets across distributed partner datasets, ensuring statistical validity while maintaining data isolation.
* Benchmark Suite Development: Create comprehensive benchmark suites covering small molecules (ADMET, solubility, permeability), antibodies (affinity, stability, immunogenicity), and RNA therapeutics (stability, delivery, off-target effects).
* Cross-Domain Validation: Develop validation strategies that assess model generalization across different experimental protocols, cell lines, species, and therapeutic indications while respecting partner data boundaries.
* Public Dataset Integration: Systematically benchmark federated models against public datasets (ChEMBL, PubChem, PDB, Therapeutic Antibody Database) to establish performance baselines and identify gaps.
* Validation Frameworks: Implement time-split or proper scaffold-split validation protocols that assess model performance on prospective data, simulating real-world deployment scenarios and detecting concept drift.
* Reproducibility Infrastructure: Build robust MLOps pipelines ensuring complete reproducibility of federated experiments, including versioning of data snapshots, model checkpoints, and hyperparameter configurations.
* Statistical Rigor: Design statistically powered validation studies accounting for multiple testing, hierarchical data structures, and non-independent observations common in drug discovery datasets.
* Performance Profiling: Develop comprehensive performance profiling across diverse molecular scaffolds, target classes, and property ranges, identifying systematic biases and failure modes.
* Platform Integration: Collaborate with engineering teams to integrate validation frameworks with the TuneLab federated learning platform built on NVIDIA FLARE, ensuring scalable and automated testing across partner networks.
Basic Qualifications
* PhD in Computational Biology, Bioinformatics, Cheminformatics, Computer Science, Statistics, or related field from an accredited college or university
* Minimum of 2 years of experience in the biopharmaceutical industry or related fields, with demonstrated expertise in drug discovery and early development
* Strong foundation in experimental design, statistical validation, and hypothesis testing
* Experience with ML model validation, cross-validation strategies, and performance metrics
* Proficiency in data engineering, pipeline development, and automation
Additional Preferences
* Experience with federated learning platforms and distributed computing
* Knowledge of regulatory requirements for AI/ML in pharmaceutical development
* Expertise in ADMET assay development and validation
* Understanding of antibody engineering and characterization methods
* Familiarity with RNA therapeutic design and delivery systems
* Experience with clinical biomarker validation and translational research
* Proficiency in workflow orchestration tools (Airflow, Kubeflow, Prefect)
* Strong knowledge of containerization and cloud computing (Docker, Kubernetes)
* Publications on model validation, benchmarking, or reproducibility
* Experience with GxP compliance and quality management systems
* Exceptional attention to detail and commitment to scientific rigor
* Strong technical writing skills for regulatory documentation
* Portfolio mindset balancing rigorous validation with rapid deployment for partner value
This role is based at a Lilly site in Indianapolis, South San Francisco, or Boston with up to 10% travel (attendance expected at key industry conferences). Relocation is provided.
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
$151,500 - $244,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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$151.5k-244.2k yearly Auto-Apply 60d+ ago
Director, Parenteral Sterility Assurance
Eli Lilly and Company 4.6
Concord, CA job
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
$133.5k-220k yearly Auto-Apply 60d+ ago
Automation Technician - Night Shift
Eli Lilly and Company 4.6
Concord, CA job
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
$63k-80k yearly est. Auto-Apply 60d+ ago
Operator, Aseptic Filling (Night Shift)
Eli Lilly and Company 4.6
Concord, CA job
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
$38k-44k yearly est. Auto-Apply 60d+ ago
Manager, Catalyze360 IT Contracts & Business Operations
Eli Lilly and Company 4.6
San Francisco, CA job
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
$69k-165k yearly Auto-Apply 14d ago
Scientist - TS/MS Parenteral
Eli Lilly and Company 4.6
Concord, CA job
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