Amgen jobs in Fremont, CA - 816 jobs

**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Grad Intern - R&D Pathology Lab** **What You Will Do** Let's do this. Let's change the world. During this program, you will work with the Pathology group in South San Francisco, CA to help develop and implement specialized tissue-based assays to support specific questions on target expression and preclinical model development. + Maintain accurate laboratory records and follow all laboratory safety and compliance guidelines. + Working with a mentor to perform immunohistochemistry (IHC) staining and contribute to assay optimization and validation. + Manage databases and input information, data, and records. + Utilize image analysis software to generate quantitative data. + Present internship findings at the conclusion of the program. **What We Expect of You** We are all different, yet we all use our unique contributions to serve patients. This research opportunity is for motivated candidates who have demonstrated a strong interest in research in the health sciences. **Basic Qualifications:** Amgen requires that all individuals applying for a grad internship at Amgen must meet the following criteria: + 18 years or older + Graduated with a bachelor's degree from an accredited college or university + Currently enrolled in an MBA program for an MBA internship OR a Master's program for a Master's internship OR a PharmD program for a PharmD internship OR Ph.D. for a PhD internship from an accredited college or university and completion of the first year of MBA OR Master's OR Pharm D OR Ph.D. program before the internship starts + Enrolled in an accredited college or university following the potential internship + Must not be employed at the time the internship starts + Student must be located in the United States for the duration of the [ **internship** **Preferred Qualifications:** + Degree concentration(s): Life Sciences, Biology or related field + Strong communication, both written and verbal + Hands-on experience with tissue-based assays, such as immunohistochemistry (IHC), or in situ hybridization (ISH). + Ability to work both independently and collaboratively in a multidisciplinary environment. **What You Can Expect of Us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The base pay range for this opportunity in the U.S. is $30-$40 per hour + Build a network of colleagues that will endure and grow throughout your time with us and beyond. + Bring your authentic self to the table and become the professional you're inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities. + Participate in executive and social networking events, as well as community volunteer projects. **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com -** **Please search for Keyword** **R-230336** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. **Sponsorship** Candidates must be authorized to work in the U.S. for the duration of this program. Sponsorship for future FTE roles is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. We are seeking a Director, HR Business Partner to partner with the U.S. Commercial organization. The Director will act as a strategic HRBP to Senior Business Leaders and Commercial Vice Presidents adopting a business-focused approach to translate objectives into actionable people plans, emphasizing organizational design, talent management, and capability building. The Director will be a member of the respective business leadership teams and the Global Commercial HRBP team to drive and implement workforce strategies that facilitate business success, promote an inclusive and high-performing culture, and embody Gilead's core behaviors and leadership accountabilities. This role reports to the Executive Director of Human Resources for Gilead U.S. Commercial. This is a hybrid/office based role located in Foster City, California. Specific job responsibilities Directs the planning, development, implementation, administration and budgeting for a portion of a large client group, or a specific geographic area. Challenges are unique and solutions may serve as a precedent for future decisions. Provides support directly to senior management and defines the HR strategy for the client group or groups supported. Advises company management on HR policy and program matters, making or recommending appropriate decisions, which may be significantly complex. Initiates discussions regarding organizational changes and presents each of the HR specialty functional areas (training, compensation, benefits, etc.) when working with management. Within client group, facilitates the management and development of the corporate culture and values, and leads employee and manager engagement initiatives to foster teamwork and enhance employee engagement. Viewed as subject matter expert and maintains contacts with external sources to stay apprised of current trends and new legislative changes. Accomplishes results as an individual contributor or through HR subordinates or specialist employees/CoE. May select, develop and evaluate HR staff to ensure the efficient operation of the function. Develops concepts, techniques, and standards for flawless execution on the delivery of HR services including talent acquisition, performance management, talent reviews, compensation planning, and project management. Develops new applications based on professional principles and theories. Provides analysis and recommendations about the reengineering and optimization of the organizational structure, roles, process and resource allocation, and facilitates change management. Designs, develops and implements communication strategy using various media. Ensures effective communication strategies are in place within the organization and builds two-way communication channels. Proactively questions the decisions of management that impact the long-term direction of the client group. Provides coaching support for site or client group leadership, building skills, knowledge, and competencies to achieve results and make employee-related decisions in a fast changing environment. May be responsible for representing client group or site with labor unions and/or works councils to ensure compliance with relevant labor laws and a favorable climate with employee representative groups. May require strong business knowledge as well as a sophisticated understanding of labor relations and union negotiation rules. Knowledge 12+ years of relevant experience in the HR field and a BA or BS degree, preferably with an emphasis in HR or Business or 10+ years of relevant experience in HR with a master's degree. Works under consultative direction toward long-range goals and objectives. Assignments are self-initiated with very little direct supervision. Excellent verbal, written, and interpersonal communication skills are required. Must possess excellent influencing skills. Requires a thorough knowledge and understanding of Human Resources legislation/employment law, principles, policies, and procedures. Must be able to develop solutions to a wide range of highly complex problems, which require an in depth degree of ingenuity, creativity, and innovativeness. May require experience and ability to manage staff. Must be able to exercise judgment and independently determine and take appropriate action within defined HR policies and procedures. Specific education and experience requirements. People Leader Accountabilities Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: $210,375.00 - $272,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the ‘Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. Job Requisition ID R0049454 Job Level Director #J-18808-Ljbffr

Abbott Laboratories is seeking an experienced commercial attorney for their Heart Failure Division in Pleasanton, CA. The role involves providing legal advice, handling complex agreements in the healthcare sector, and ensuring compliance with various regulations. Candidates should have a Juris Doctor and significant experience in related fields. This opportunity offers competitive compensation and benefits as part of a global leader in medical devices. #J-18808-Ljbffr

A leading biopharmaceutical company in California seeks an Associate Director of Sales Analytics & Operations. This role involves managing tasks supporting healthcare specialists and leading cross-functional projects. The ideal candidate has over 10 years of experience, excellent communication skills, and a background in data analysis. The position offers competitive compensation and is critical for driving business insights within the organization. #J-18808-Ljbffr

A leading biopharmaceutical company in Foster City is seeking an Associate Director/Principal Scientist to lead cell culture development for biologics programs. The ideal candidate will have significant experience in process development and team management, with a Ph.D. or relevant degree. This role involves optimizing processes, mentoring team members, and ensuring compliance with regulatory requirements. #J-18808-Ljbffr

* Lead, manage, develop, coach, and grow a high performing team that demonstrates strong market research competencies with healthcare providers and consumers and delivers results.* Lead market research strategy, planning, vendor contracts and manage the functional budget.* Engages with key US marketing and cross-functional stakeholders to develop and execute market research to shape the strategies and tactics critical to successfully meet business objectives.* Demonstrate experience generating superior customer market research insights, individually and through direct reports, to provide a competitive advantage.* Ensure team provides HIV Prevention expertise and consulting advice in areas of critical business need including identification of optimal pre- and post-launch brand strategies and marketing tactics.* Demonstrates broad cross functional leadership. Manage cross-functional collaboration processes to ensure development of insightful market research plans that systematically and holistically address brands' strategic objectives and tactical requirements.* Represent HIV Prevention Integrated Insights function at appropriate senior level meetings and make recommendations to advance the portfolio based on a sound knowledge of the marketplace.* Shares best practices across market research and brand marketing teams and fosters agility and continuous improvement within the group to address emerging and shifting priorities of the commercial business.* Direct activities to support the professional development of the HIV Prevention Market Research team and support recruitment and employee retention to achieve best in industry capabilities.* Ensure compliance with company policies, standards and procedures in every interaction. Enforce compliance with guidelines and policies on marketing research interactions with physicians.* Bachelor's Degree required, Masters/PhD preferred* Experience in Pharmaceutical, Biotech or related industry experience dependent on experience and education level.* Foundation of experience in HIV or virology therapy areas and experience with provider-administered (e.g. buy-and-bill) products is desired.* 10+ years of relevant experience in market research field* Demonstrated successful leadership, management, and development of teams responsible for market research. Strong judge of talent with the ability to make tough talent decisions.* Thorough understanding of pharmaceutical sales and marketing practices, product lifecycle management and regulatory environment.* Demonstrated ability to drive large cross-functional initiatives, as well as influence laterally and vertically.* Ability to manage multiple priorities based on changing business needs, as well as ability to work in a team-based, fast-paced environment.* Strong organizational, planning, communication and project management skills.* Strong understanding of primary qualitative and quantitative market research techniques and their optimal uses to inform business decisions.* Proven experience in storytelling and data visualization to communicate complicated analytics clearly for cross-functional stakeholders and senior management.* Persuasive written and verbal communication skills, ability to lead, influence, resolve conflict and drive consensus among diverse cross functional stakeholders. #J-18808-Ljbffr

A leading biopharmaceutical company in California is seeking a professional with strong marketing skills and an emphasis on HIV-related experience. The ideal candidate will work with external agencies and contribute to the development of impactful marketing programs. Applicants should have a bachelor's degree, extensive experience in marketing, and an ability to thrive in a fast-paced environment. The role entails collaboration, communication, and a sensitivity to the topics in the HIV market, with potential for domestic travel. #J-18808-Ljbffr

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. Advances in AI, data, and computational sciences are transforming drug discovery and development. Roche's Research and Early Development organisations at Genentech (gRED) and Pharma (pRED) have demonstrated how these technologies accelerate R&D, leveraging data and novel computational models to drive impact. Seamless data sharing and access to models across gRED and pRED are essential to maximising these opportunities. The new Computational Sciences Center of Excellence (CoE) is a strategic, unified group whose goal is to harness this transformative power of data and Artificial Intelligence to assist our scientists in both pRED and gRED to deliver more innovative and transformative medicines for patients worldwide. Opportunity At Roche\'s AI for Drug Discovery (AIDD) group (Prescient Design), we are revolutionizing drug discovery with cutting-edge machine learning techniques. We are seeking a highly motivated and skilled ML Infrastructure DevOps Engineer to join our growing team within Genentech Research and Early Development AI Drug Development (gRED AIDD). This role is crucial for building and maintaining the scalable and robust infrastructure that powers our machine learning initiatives. The ideal candidate will be proactive, user-facing, and possess a "get-it-done" attitude, while consistently adhering to corporate standards and best practices. Responsibilities Design, implement, and maintain scalable and reliable ML infrastructure on AWS. Automate deployment, monitoring, alerting, and operational tasks using tools like Terraform and Helm. Manage and optimize CI/CD pipelines and Git repositories for ML projects, ensuring efficient version control to support collaboration and deployment. Collaborate closely with ML engineers and data scientists to understand their infrastructure needs and provide solutions. Troubleshoot and resolve infrastructure-related issues in a timely manner. Implement and enforce security best practices for ML infrastructure. Document infrastructure designs, processes, and operational procedures. Contribute to initiatives independently as part of a team, delivering assigned outputs. Proactively identify issues and gaps, proposing ideas and suggestions for improvements. Who you are / Qualifications Proven experience in designing, deploying, and managing infrastructure on Amazon Web Services (AWS), including services such as EC2, S3, RDS, EKS, SageMaker, etc. Strong proficiency with Git and Git repository management. Hands-on experience with Terraform for infrastructure provisioning and management. Experience with Helm for deploying and managing applications on Kubernetes. Proficiency in scripting languages (e.g., Python, Bash) for automation. Excellent problem-solving skills and a strong ability to debug complex issues. Strong communication and interpersonal skills to effectively collaborate with cross-functional teams and user-facing interactions. Demonstrated ability to take initiative, anticipate needs, and drive projects to completion. Ability to thrive in a fast-paced environment and adapt to evolving requirements while adhering to corporate guidelines. Ability to write clean code with little syntax/convention feedback. Applies software engineering best practices (linting automation, unit testing, documentation, CI/CD). Familiarity with modern machine learning methods. Knowledge of and experience with high-performance computing, distributed systems, and cloud computing. Preferred Experience with MLOps platforms and tools. Familiarity with CI/CD pipelines for ML workflows. Knowledge of monitoring and logging tools (e.g., Prometheus, Grafana, ELK stack) Relocation benefits are available for this job posting. The expected salary range for this position based on the primary location of California is $147,600 - $274,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company\'s policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. #J-18808-Ljbffr

A leading biopharmaceutical company is seeking an experienced leader in global public affairs to drive strategies for expanding access to medicines, particularly in low- and middle-income countries. The role involves building partnerships, managing communications, and developing initiatives with patient communities and stakeholders. Strong communication skills, analytical capabilities, and proven leadership are essential. Candidates should possess a relevant bachelor's degree, with a master's or MBA preferred. This role requires travel 30-40% of the time. #J-18808-Ljbffr

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Menlo Park, CA location in the Structural Heart division. Structural Heart Business Mission: Why We Exist Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. What You'll Work On Market Sustaining Team - Manufacturing Engineers that support our market products. How we can improve products, occasionally dealing with field complaints. Independently, or lead a project team to identify fluid loss within a process and identify solution to reduce the fluid loss. Understand the business needs of the company and have a thorough understanding of customer needs as they relate to projects. Lead kaizens to identify root cause within manufacturing process. Work with team to develop corrective and preventative actions. Design and lead complex experiments, often with multiple variables, independently execute and/or direct others in the execution of project tasks by applying novel engineering theories, concepts and techniques. Conceptualize complete solutions, create or coordinate the design solutions for novel or complex problems; explore multiple alternatives. Serve as a subject matter expert (SME) or independent technical expert (ITE) on a project's technical matters; may interface with senior management, external firms or agencies, coordinating technical matters between organizations. Responsible for completing documentation in a timely manner and in accordance with business standards. Participate on cross‑functional teams to support organizational goals. Understand and comply with applicable EHS policies, procedures, rules and regulations. Responsible for implementing and maintaining effectiveness of the Quality System. Other tasks and duties as assigned. Required Qualifications Bachelor's Degree (±16 years) in Engineering or similar. Typically requires 5 years of relevant work experience preferred as a Manufacturing Engineer. Ability or aptitude to work on problems that are complex in scope. Demonstrated initiative and problem‑solving skills; critical‑thinking skills. Ability to use various types of databases and other computer software. Strong organizational and project management skills. Ability to quickly gain knowledge, understanding or skills and willingness to learn. Knowledge of Lean Six Sigma concepts is an asset. Compensation The base pay for this position is $90,000.00 - $180,000.00. In specific locations, the pay range may vary from the range posted. EEO Statement Abbott is an Equal Opportunity Employer, committed to employee diversity. Apply Now #J-18808-Ljbffr

A leading biopharmaceutical company is seeking a Principal Scientist in Analytical Ops in Foster City, California. The role involves leading analytical development, mentoring scientists, and ensuring product quality for biologics. Ideal candidates will have extensive experience in analytical method development and a strong background in regulatory compliance. The position offers an opportunity to work in a collaborative environment that supports innovation and patient-centric solutions. #J-18808-Ljbffr

* Bachelor's degree in Finance, Accounting, Business, or related field; advanced degree (MBA, MS) preferred.* 12+ years of relevant experience in FP&A, with increasing responsibility; experience in biotech/pharma or R&D finance strongly preferred.* Proven track record of supporting business partners and driving financial performance.* Experience with US GAAP, planning/ERP systems, and financial reporting.* People management experience a plus. #J-18808-Ljbffr

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a Fortune 500 company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and technical organization from the ground up. The Principal Scientist/Engineer - Cleaning Validation/Sterilization Validation - Technical Services / Manufacturing Science (TS/MS) role is a technical position that develops and supports the validation of production equipment and systems and provides technical leadership regarding temperature mapping, cleaning and sterilization validation strategies. Primary objectives include the start-up and compliant manufacturing of products, particularly as it relates to development and implementation of validation strategies, including sterilization validation, cleaning validation, filter validation, and other related activities. The scope of the role includes device assembly, packaging, and syringe filling operations for commercially manufactured products targeted for transfer to the Concord site. Key Objectives / Deliverables: * Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. * Provide technical support for all start-up activities related to temperature mapping, cleaning and sterilization programs. * Development and execution of cleaning and sterilization strategies that focus on the validation of production equipment and systems (e.g., tanks, component/parts washer, autoclaves, filling isolators, etc). * Support periodic requalification activities for production equipment and systems. * Author and support the execution of validation protocols and reports. * Provide technical guidance to the Process Team for cleaning and sterilization processes. * Lead or provide technical support for root cause investigations related to cleaning, sterilization, and other related activities. * Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements. * Coordinate with cross-functional process teams for the implementation of projects identified to improve productivity, quality, or continuous improvement of cleaning and sterilization processes. * Participate or provide guidance for equipment cleaning and sterilization programs during internal and external audits, including regulatory inspections, as needed. * Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc. * Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda. * Serve as cleaning and sterilization interface external to the Concord site. * Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives. * Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain. * Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities. Minimum Requirements: * BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline * 3+ years experience supporting cGMP manufacturing (specifically within validation, engineering, technical services/MSAT, operations, quality assurance, etc.) Additional Preferences: * In depth knowledge of parenteral drug product manufacturing * Experience executing equipment qualification, cleaning validation, and sterilization validation * Demonstrated successful leadership of cross-functional teams * Experience with data trending and analysis * Ability to analyze complex data and solve problems Other Information: * Role is Monday through Friday based. * Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). * Occasional extended hour and / or off-hour work may be required. * Position will be based out of Concord site with ability to travel to Indianapolis and other global Lilly sites as required Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Director, Device EngineeringUnited States - California - Foster City Manufacturing Operations & Supply Chain Regular At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Specific Job Responsibilities Build, lead, and inspire a high-performing team o f engineers, fostering a culture of collaboration, accountability, innovation, and continuous development within the device development function. Champion a systems-based approach to product development, ensuring that all combination products are treated as integrated systems encompassing drug, device, user interface, and delivery performance. Influence and collaborate effectively across the organization, including with clinical, regulatory, quality, commercial, and manufacturing teams, to align on product strategy, development priorities, and risk management. Reinforce and communicate the value proposition of drug-device combination products, advocating for user-centric design, differentiated delivery platforms, and the strategic role of devices in enhancing therapeutic outcomes. Ensure robust design control and risk management practices are followed across all device programs, in alignment with global regulatory requirements (e.g., FDA, EMA, ISO 13485, ISO 14971). Establish and maintain strong relationships with external partners and suppliers, ensuring alignment on technical requirements, timelines, and quality expectations. Required Education & Experience Bachelor's Degree and Twelve Years' Experience OR Masters' Degree and Ten Years' Experience OR PhD and Eight Years' Experience Preferred Experience Experience leading combination product development projects and managing device engineers . A Bachelor's Degree in Mechanical Engineering , Chemical Engineering, Biomedical Engineering, or a related scientific field and a minimum of ten (10) years of relevant industry OR a Master's Degree and a minimum of eight (8) years of relevant industry. Experience with the development and commercialization of combination products. Working knowledge of FDA, EMA, and cGMP standards for combination products. Strong verbal, written, and interpersonal communication skills . Able to write clear, concise, and error-free documents. Able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action. People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description We are seeking a dynamic and people-focused Director of Device Development to lead a team of engineers in the design and delivery of parenteral drug-device combination products, including prefilled syringes and autoinjectors. This role is centered on building a strong team culture, fostering cross-functional collaboration, and reinforcing the strategic value of combination products as integrated product systems. The ideal candidate will be a skilled leader who can influence across the organization, drive alignment, and champion the role of device innovation in enhancing patient outcomes. This is a high-impact leadership position with a strong emphasis on team development, organizational influence, and strategic execution. Specific Job Responsibilities Build, lead, and inspire a high-performing team o f engineers, fostering a culture of collaboration, accountability, innovation, and continuous development within the device development function. Champion a systems-based approach to product development, ensuring that all combination products are treated as integrated systems encompassing drug, device, user interface, and delivery performance. Influence and collaborate effectively across the organization, including with clinical, regulatory, quality, commercial, and manufacturing teams, to align on product strategy, development priorities, and risk management. Reinforce and communicate the value proposition of drug-device combination products, advocating for user-centric design, differentiated delivery platforms, and the strategic role of devices in enhancing therapeutic outcomes. Ensure robust design control and risk management practices are followed across all device programs, in alignment with global regulatory requirements (e.g., FDA, EMA, ISO 13485, ISO 14971). Establish and maintain strong relationships with external partners and suppliers, ensuring alignment on technical requirements, timelines, and quality expectations. Required Education & Experience Bachelor's Degree and Twelve Years' Experience OR Masters' Degree and Ten Years' Experience OR PhD and Eight Years' Experience Preferred Experience Experience leading combination product development projects and managing device engineers . A Bachelor's Degree in Mechanical Engineering , Chemical Engineering, Biomedical Engineering, or a related scientific field and a minimum of ten (10) years of relevant industry OR a Master's Degree and a minimum of eight (8) years of relevant industry. Experience with the development and commercialization of combination products. Working knowledge of FDA, EMA, and cGMP standards for combination products. Strong verbal, written, and interpersonal communication skills . Able to write clear, concise, and error-free documents. Able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action. People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem The salary range for this position is: $210,375.00 - $272,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. Share: Job Requisition ID R0045917 Full Time/Part Time Full-Time Job Level Director Click below to return to the Gilead Careers site Click below to see a list of upcoming events Click below to return to the Kite, a Gilead company Careers site #J-18808-Ljbffr

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. 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 * 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) NOTE: This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the . For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $17.30 - $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

A leading biotech company in California is seeking an Associate Director of Device Engineering to oversee the lifecycle of drug-device combination products. This role involves leading cross-functional teams, managing product development, and ensuring supply chain continuity. Ideal candidates will have a doctoral degree and extensive experience in medical device commercialization. The company offers competitive compensation and a full benefits package. #J-18808-Ljbffr

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Overview Lilly Catalyze360 is Lilly's comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars-Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly TuneLabs-Catalyze360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning. Lilly ExploR&D is a team of drug discovery and development experts who partner with biotechs from discovery through clinical proof-of-concept, putting Lilly's industry-leading capabilities behind their missions. We provide flexible support-from strategic consulting to full program execution-making it faster, easier, and more capital-efficient for innovators to transform bold science into life-changing medicines. Job Summary The ExploR&D Program Lead (EPL) serves as the single point of accountability for external collaboration projects within Lilly's ExploR&D organization. The role focuses on defining strategy, developing aggressive timelines and budgets, and leading cross-functional teams from Catalyze360 and Lilly Research Laboratories to deliver high-quality results on time and on budget. Reporting within the Catalyze-360 Project Management structure, the EPL leads diverse, cross-functional teams to deliver innovation by pioneering novel science and technologies that advance future medicines and transform R&D collaboration models. Key Responsibilities Team Leadership and Project Management Lead multiple collaboration teams comprised of ExploR&D personnel, LRL subject matter experts and external biotech collaborators. Create a high-performing team with a culture of trust, autonomy, agency, collaboration, and inclusion. Deliver projects ‘on time, on budget', and within scope from discovery/pre-clinical development through clinical proof-of-concept using contemporary project management tools and approaches. Scientific and Technical Leadership Identify and synthesize relevant, technical information from a variety of sources including scientific literature, internal and external subject matter experts, and experimental or trial data to address key questions and guide study design and program strategy. Provide and critically evaluate content within critical documents (e.g., Investigator Brochures, Risk Profiles, Study Protocols, Study Reports, Regulatory and Ethical filings and updates, Investigator updates, etc.). Serve as the ExploR&D scientific leader responsible for rationale, integration of cross-functional data, synthesis of the risk/benefit profile, strategic conclusions, and designs to drive data-driven decision making. Collaboration and Relationship Management: Serve as primary liaison between Lilly and external biotech collaborators, fostering strong relationships, transparent communication and ensuring alignment on project goals. Anticipate and resolve barriers to success by identifying potential roadblocks early, offering innovative solutions, and ensuring that collaboration programs are executed with excellence. Create a ‘partner of choice' experience accounting for partner's goals and priorities, optimizing strategic plans with the spirit of an entrepreneurial drug developer to enable stakeholder decision-making and value-creation. Operational Excellence and Process Improvement: Contribute to diligence and workplan development that optimize outcomes for Lilly and external collaborators. Drive operational excellence in program management by identifying and implementing process improvements that enhance the efficiency and effectiveness of external collaborations. Basic Qualifications/Requirements Education: Advanced graduate degree (PhD, PharmD, or Masters) in a health-related, scientific or engineering field Experience: 10+ years of work experience in the pharmaceutical industry including preclinical-translational sciences and/or clinical drug development across therapeutic modalities such as cell and gene, antibodies, peptides, oligonucleotides, vaccines, and small molecules. Additional Skills/Preferences Fluent Mandarin speaking and writing skills. Prior experience managing external collaborations with proven track record of overseeing complex, cross-functional and external partnering projects. Demonstrated ability to lead and influence teams in a matrixed environment, driving collaboration across diverse functions and geographies. Exceptional verbal and written communication skills, with ability to clearly articulate project goals, strategies, and results to both internal and external stakeholders. Demonstrated ability to anticipate challenges, diagnose root causes, and implement creative solutions that drive project success. Strong intuition for business, with a deep understanding of asset strategy, portfolio management, and the broader pharmaceutical landscape. Practical experience or certification in project management. Intellectual agility to quickly adapt to changing circumstances, learn from past experiences, and apply learnings to new situations. Strong ability to think with a portfolio-level mentality, ensuring that individual program decisions align with the overall goals of ExploR&D and Catalyze360. Additional Information Location: San Francisco, CA Travel up to 25% Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $187,500 - $275,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The Deviation Mentor is a key member of the Quality Assurance (QA) team, responsible for teaching, mentoring, and guiding deviation and laboratory investigations. This role oversees the training program related to deviation investigations, participates in deviation assessments (pre-approval and post-approval), and may lead complex investigations. The Deviation Mentor also collaborates in regulatory inspections, site inspection readiness, and issue resolution. In addition, this role will serve as the site steward for One Quality Management System (One QMS) during the project phase. Key Responsibilities: Deviation Investigation & Guidance * Provide expert guidance to lead investigators on deviation investigations, including root cause analysis, quality impact evaluations, and technical writing. * Assist and advise deviation reviewers and approvers on issue investigation matters. * Lead complex investigations and act as a technical reviewer for deviations and analytical investigations. * Lead or participate in deviation review boards, ensuring thorough pre-approval and post-approval reviews. * Support the development and review of deviation trend reports. * Design and deliver training programs related to deviations and investigations. * Develop site-specific deviation and investigation metrics. One QMS Responsibilities * Manage the transition of the Quality Management System (QMS) from TrackWise to Veeva for the Concord site. * Collaborate with the global QMS I3 team to align site deliverables and timelines. * Present progress reports on QMS I3 implementation to site leadership, including key actions and timelines. * Act as the Power User and Site Instructor for the QMS I3 Veeva system, covering deviations, change controls, and CAPA. * Author and review documentation as a Subject Matter Expert for the Concord site's QMS I3 implementation. Qualifications: * Bachelor's or Master's degree in a scientific or technical field (e.g., chemistry, biology, microbiology, engineering). * 5+ years of experience in pharmaceutical manufacturing operations with preference for parenteral manufacturing * Strong technical writing, critical thinking, and organizational skills. * Exceptional communication and interpersonal skills, with a proven ability to provide constructive, actionable feedback to enhance technical document clarity and quality. * Demonstrated talent for fostering a collaborative environment where open dialogue and positive critique drive continuous improvement in deviation writing practices. * Good knowledge of cGMP, regulatory standards, and quality system requirements. Preferred Attributes: * 7+ years in QA roles within the pharmaceutical or medical device industry. * Experience with GMP systems, including Deviation Management and Document Control systems. * Advanced technical proficiency in deviation management, CAPA, change control, and product complaint handling. * Regulatory inspection experience, including readiness and execution * Familiarity with TrackWise, Veeva, and parenteral product materials. * Proven ability to lead global or local project implementations and influence cross-functional teams. Other Information: * Occasional off-hours or weekend support for 24/7 manufacturing operations. * Travel: Up to 10%. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $162,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **R&D Pharmacokinetics and Drug Metabolism - Grad Intern** **What You Will Do** Let's do this. Let's change the world. During this program, you will apply principles of pharmacokinetics/pharmacodynamics (PK/PD), translational pharmacology, and mechanistic modeling to inform decisions in early drug discovery projects. Specifically, you will: + Collaborate with scientists across disciplines to identify key questions in early drug discovery projects and design strategies to address them. + Integrate knowledge of target biology, translational pharmacology, modality-specific pharmacokinetics, and modeling and simulation to guide project strategy and chemical matter optimization. + Document methodologies, assumptions, risks, and actionable recommendations in written reports and communicate findings to cross-functional teams. + Contribute to the development, refinement, and automation of quantitative tools and standardized workflows that drive decision-making in drug discovery. **What We Expect of You** We are all different, yet we all use our unique contributions to serve patients. We seek a collaborative and driven scientist with these qualifications: **Basic Qualifications:** Amgen requires that all individuals applying for a grad internship at Amgen must meet the following criteria: + 18 years or older + Graduated with a bachelor's degree from an accredited college or university + Currently enrolled in an MBA program for an MBA internship OR a Master's program for a Master's internship OR a PharmD program for a PharmD internship OR Ph.D. for a PhD internship from an accredited college or university and completion of the first year of MBA OR Master's OR Pharm D OR Ph.D. program before the internship starts + Enrolled in an accredited college or university following the potential internship + Must not be employed at the time the internship starts + Student must be located in the United States for the duration of the internship **Preferred Qualifications:** + Currently pursuing a PhD in pharmacokinetics, pharmaceutical sciences, chemical or biomedical engineering, or a related discipline. + Demonstrated experience with PK/PD, QSP, or PBPK modeling or other computational modeling and data analysis methods. + Familiarity with basic data science concepts and Python scripting to enhance and modularize analyses and promote reproducible workflows. + Familiarity with the drug discovery and development process, particularly in preclinical or translational settings. + Strong written and verbal communication skills, with the ability to collaborate effectively across multidisciplinary teams. **What You Can Expect of Us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The base pay range for this opportunity in the U.S. is $30-$40 per hour + Build a network of colleagues that will endure and grow throughout your time with us and beyond. + Bring your authentic self to the table and become the professional you're inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities. + Participate in executive and social networking events, as well as community volunteer projects. **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com -** **Please search for Keyword** **R-231131** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. **Sponsorship** Candidates must be authorized to work in the U.S. for the duration of this program. Sponsorship for future FTE roles is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.