Halozyme jobs - 1,118 jobs

The Position: The Opportunity We are seeking an exceptional Principal Scientist (Group Leader) to join our world-class Antibody Engineering Department, where we discover and engineer life-changing antibody drugs through pioneering science and technology. The successful candidate will lead a scientific team to enhance existing platforms and develop novel technologies to expand our pipeline of antibody-based drugs across therapeutic areas. You will focus on these areas Contribute to research at the interface between technology and biology Define important therapeutic problems in collaboration with Genentech's therapeutic areas Drive innovation to solve them through antibody engineering Our new Scientist/Group Lead will help shape the future of our antibody drug capabilities and will be expected to present their research externally and publish in peer-reviewed journals. The hire will work collaboratively in a multi-disciplinary team environment to design, validate, and advance next generation biologics that address major unmet medical needs into clinical development. We are seeking highly motivated and self-driven candidates with a passion for innovation, creativity, and commitment to translational science and drug development. Who You Are PhD in a biological science, complemented by postdoctoral training or 4+ years recent equivalent antibody engineering in academia, biotechnology and/or pharma. We encourage applications from candidates with extensive prior experience as well as those coming directly from exemplary postdoc careers. The successful candidate will have demonstrated a sustained record of productivity and substantive scientific contributions as determined by consistent high-impact publications, patent inventorship, and/or external presentations. Candidates need to be team-oriented, collegial, and have strong interpersonal and communication skills. Preferred Ideal applicants will excel in protein engineering methodologies and be well-versed in biology. Experience with engineering bi- or multi-specific antibody/protein formats is preferred. Experience with structure-based protein analysis is a plus. Research experience with antibodies is preferred but is not essential. Relocation benefits are available for this job posting. The expected salary range for this position based on the primary location of California is $143,200 to $265,900. 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 #LI-KC2 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 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

We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. 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 Kite and help create more tomorrows. The Senior Clinical Trials Management Associate is a primarily an in‑house sponsor position (though some travel is required) who will oversee multiple aspects of clinical trial conduct including study start‑up, document generation and review, tracking of sample enrollment of study participants, and management of vendors. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. The position will report to a Senior Clinical Trials Manager of Clinical Operations. Responsibilities Prepares and/or reviews study‑related or essential study start‑up documents as they relate to the supported clinical trials as delegated by the study manager (e.g., Clinical protocols, Informed Consent Forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form [CRFs], CRF Completion Guidelines and other relevant study plans and charters). Works with multiple contract research organizations to communicate detailed timelines and ensure that transferred obligations and performance expectations are met. Provides corrective instruction, as necessary, when performance expectations are not being met. Attends internal team and other meetings as required. Provides training, as necessary, at investigator meetings and other trial‑specific meetings such as site initiation visits and monthly teleconferences. Creates and reviews site feasibility assessments required for study participation. Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations. Proactively identifies potential study issues/risks and recommends/implements solutions; ensures issues are escalated as appropriate to Senior Manager. Prepares metrics and updates to key deliverables for management. Assists in the resolution of clinical trial queries and data review for interim analysis, primary analysis and final database locks. Prepares site newsletters and other correspondence related to clinical trial conduct (e.g., best practices and lessons learned, frequently asked questions) in collaboration with the study team. Assists in resolution of routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol. May lead less complex studies and/or manage components of more complex studies as a member of the study team. May participate in department initiatives or special projects, such as developing new tools or processes. Ability to coach less experienced colleagues in solving problems. Understands how decisions have an impact to the broader study goals. Other duties as assigned. Basic Qualifications BS/BA and 4+ years of related experience - OR - MS/MA and 2+ years of related experience Preferred Qualifications At least three years of clinical trial experience with oncology, hematology, cell therapy or related therapeutic area experience considered a plus. Multiple years of experience managing the work of external candidates. Must be willing to travel at least 25% (possibly more). Ability to manage time demands, incomplete information or unexpected events. Must display strong analytical and problem‑solving skills. Attention to detail required. Outstanding organizational skills with the ability to multi‑task and prioritize. Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment. Comfortable in a fast‑paced small company environment with minimal direction and able to adjust workload based upon changing priorities. Working knowledge of transplant patient care and apheresis collection a plus. Salary & Benefits Salary range: $115,260.00 - $149,160.00. The 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*. * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For additional benefits information, visit ****************************************************************** About Kite Pharma Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long‑term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit ******************* Sign up to follow @KitePharma on Twitter at *************************** Equal Employment Opportunity Statement Kite Pharma 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. Additional Notices Notice: Employee Polygraph Protection Act. Your rights under the Family and Medical Leave Act. Healthy work environment: Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. Application Instructions For current Kite Pharma employees and contractors: apply via the Internal Career Opportunities portal in Workday. Job Requisition ID R0049437 #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 in California seeks a Senior Manager, FP&A - Oncology Program Finance to support clinical spend and financial processes. The ideal candidate must have over 8 years of finance experience, strong analytical capabilities, and proficiency in Excel. This role involves partnership with Clinical Operations and leadership in financial analysis and reporting. A Master's degree or CPA is preferred, along with experience in the biotech sector. #J-18808-Ljbffr

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

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. The primary responsibility of this position is to lead biotransformation activities in the Drug Metabolism Department and in collaboration with the Clinical group. The scientist will be the subject matter expert and provide strategy/guidance to project teams for advancement of candidate compounds. This job role will focus on metabolite profiling and characterization of those compounds in vitro and in vivo to understand metabolic pathways to support drug discovery and development. More broadly, the scientist is expected to integrate this information with absorption, distribution and excretion data for candidate compounds for a full understanding of their drug metabolism and pharmacokinetic (PK) behavior. This will include representation of the department on multidisciplinary project teams. Supervision and mentoring of other scientists and/or laboratory staff will be required. This role will be based in our headquarters in Foster City, CA. Essential Duties and Job Responsibilities: Work closely with internal and external resources to assure high quality and timely delivery of nonclinical and clinical biotransformation data for molecules in discovery and development, including 14C mass balance studies. Design and perform complex analyses to characterize biotransformation and disposition of candidate drugs. Serve as a drug metabolism and biotransformation subject matter expert for multiple dynamic cross-functional teams, to define strategies to achieve target product profiles, integrate in vitro and in vivo drug disposition data, interpretation, and give presentations to teams. Provide clear verbal communication of results and strategies at group, department, project team and management level. Write research reports and regulatory documents. Contribute to science through conference presentations and publication of new findings. Basic Qualifications: Bachelor's Degree and Twelve Years' Experience OR Masters' Degree and Ten Years' Experience OR PhD and Eight Years' Experience Preferred Qualifications: A highly motivated individual with PhD degree in life sciences with 8 - 10 years of post-doctoral and/or industry experience directly related to the Specific Responsibilities listed above (hands-on experience and deep knowledge of biotransformation and structure elucidation). Considered an expert in metabolic routes of biotransformation and metabolite identification demonstrated through presentation/publication. Comfortable working with and educating colleagues in drug metabolism, toxicology and clinical pharmacology departments, on strategies to understand drug metabolism and disposition. Demonstrates excellent scientific verbal and technical communication, and interpersonal skills. Must be organized, pay attention to details and have strong organizational and planning skills. Expertise and experience in one or more of the following areas: Lead design and execution of nonclinical and clinical radio- and non-radiolabeled ADME studies. Serve as an expert resource; to ensure radiochemical design, develop protocols and placement of studies. Provide oversight and integration of the data and data reports. Proactively manage resolution of data gaps. Ensure reports are written to communicate clear messages and are ready for regulatory submissions. State of the art bioanalysis by LC/MS, F-NMR and related techniques 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. 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 The primary responsibility of this position is to lead biotransformation activities in the Drug Metabolism Department and in collaboration with the Clinical group. The scientist will be the subject matter expert and provide strategy/guidance to project teams for advancement of candidate compounds. This job role will focus on metabolite profiling and characterization of those compounds in vitro and in vivo to understand metabolic pathways to support drug discovery and development. More broadly, the scientist is expected to integrate this information with absorption, distribution and excretion data for candidate compounds for a full understanding of their drug metabolism and pharmacokinetic (PK) behavior. This will include representation of the department on multidisciplinary project teams. Supervision and mentoring of other scientists and/or laboratory staff will be required. This role will be based in our headquarters in Foster City, CA. Essential Duties and Job Responsibilities: Work closely with internal and external resources to assure high quality and timely delivery of nonclinical and clinical biotransformation data for molecules in discovery and development, including 14C mass balance studies. Design and perform complex analyses to characterize biotransformation and disposition of candidate drugs. Serve as a drug metabolism and biotransformation subject matter expert for multiple dynamic cross-functional teams, to define strategies to achieve target product profiles, integrate in vitro and in vivo drug disposition data, interpretation, and give presentations to teams. Provide clear verbal communication of results and strategies at group, department, project team and management level. Write research reports and regulatory documents. Contribute to science through conference presentations and publication of new findings. Basic Qualifications: Bachelor's Degree and Twelve Years' Experience OR Masters' Degree and Ten Years' Experience OR PhD and Eight Years' Experience Preferred Qualifications: A highly motivated individual with PhD degree in life sciences with 8 - 10 years of post-doctoral and/or industry experience directly related to the Specific Responsibilities listed above (hands-on experience and deep knowledge of biotransformation and structure elucidation). Considered an expert in metabolic routes of biotransformation and metabolite identification demonstrated through presentation/publication. Comfortable working with and educating colleagues in drug metabolism, toxicology and clinical pharmacology departments, on strategies to understand drug metabolism and disposition. Demonstrates excellent scientific verbal and technical communication, and interpersonal skills. Must be organized, pay attention to details and have strong organizational and planning skills. Expertise and experience in one or more of the following areas: Lead design and execution of nonclinical and clinical radio- and non-radiolabeled ADME studies. Serve as an expert resource; to ensure radiochemical design, develop protocols and placement of studies. Provide oversight and integration of the data and data reports. Proactively manage resolution of data gaps. Ensure reports are written to communicate clear messages and are ready for regulatory submissions. State of the art bioanalysis by LC/MS, F-NMR and related techniques 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: $226,185.00 - $292,710.00. 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 R0045101 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

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

A leading biopharmaceutical company is seeking a Senior Director, HR Business Partner to shape talent strategies for their Commercial Organization in Santa Monica, CA. This role involves organizational development, advising leaders, and enhancing talent acquisition and development processes. The ideal candidate will have extensive experience in Human Resources, strong leadership competencies, and a commitment to inclusion and diversity. The position requires on-site presence three days a week. #J-18808-Ljbffr

Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site. In order to move forward, you will need to create an account. Your password must be eight characters long, contain at least one special character, one capital letter and a number. We look forward to discovering your talents. Welcome to an inspired career. At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team - we rise by lifting others up and believe in the power of working together for the collective win. That's why we need you-to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive. Join us as a Director, Transactions Counsel and you'll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people's lives. How you will make an impact The Director, Transactions Counsel, is part of the legal team supporting Halozyme's business and part of a collaborative team of lawyers that negotiate and draft agreements alongside their business peers. The Director, Transactions Counsel independently reviews, negotiates and prepares agreements and other documents for transactions and supports a wide range of general business agreements that support the operations of the business. In this role, you'll have the opportunity to: Collaboratively support the legal team in the execution of strategies and tactics required to achieve Halozyme business goals. Independently draft, review, and negotiate a wide range of general business agreements that support both the operations of the business. This includes, but is not limited to: Information Technology transactions, such as software license agreements, SaaS agreements, and other technology-related contracts that support R&D, regulatory, and commercial functions Operational and supply chain agreements, including GxP-compliant manufacturing agreements, equipment purchase and lease agreements, supplier/vendor contracts, and service and development agreements Cross-functional support, providing legal guidance for transactions that intersect with quality, regulatory, clinical, and commercial operations across both drug and device product lines. Attorney review of contracts manager work product Lead, influence, as well as work collaboratively in teams of multi-functional business and legal colleagues. Advise business colleagues on interactions with key supply chain and other commercial relationships, including advising on actual or potential disputes. Manage external transactional counsel supporting the business needs. Interface with current partners, vendors, law firms, and others as needed To succeed in this role, you'll need: J.D. degree or LL.M. degree from an ABA accredited law school, and admission to practice law in a jurisdiction in the U.S. with a minimum 5 years of direct legal experience supporting business-to-business manufacturing, supply and product sales operations, including negotiating and drafting complex commercial agreements. (An equivalent combination of education and experience may be considered) Strong understanding of the regulatory and operational landscape of the life sciences industry, excellent judgment, and the ability to manage complex transactions with minimal oversight. Experience and leadership in working alongside business colleagues and providing real-time guidance and advice on a range of business transactions. Experience in supporting commercial pharmaceutical products and/or clinical trial programs and negotiating and drafting agreements for such business operations is also preferred. Strong written and oral communication, as well as requisite interpersonal skills to work in a highly functioning, collaborative environment. Excellent analytical and drafting skills. In return, we offer you: Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching. Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement. A collaborative, innovative team that works as one to amplify your impact-on your career, the work you do and patients' lives. The most likely base pay range for this position is $180K- $252K per year. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual's exact level of compensation. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses, sales incentives, and equity awards. Halozyme, Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Accessibility and Reasonable Accommodations: Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or accommodation due to a disability, contact Human Resources at ******************. To view all our open positions, please visit our career page . Additionally, our benefit offerings can be found here .

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. Director, Talent Management About the role The Director, Talent Management will lead in developing tools and approaches to support our Talent Management strategy, specifically related to identification and assessment of both talent and the role and/or capability needs for the future. This role will work with the Talent, Development and Inclusion team, HR Business partners, People partners, HR Shared Services, and business leaders to develop innovative approaches, as well as clear discipline and practices to support talent development. The Director, Talent Management will partner in defining what we mean by talent and the role of talent in an AI-enabled workforce, inclusive ways to identify talent and targeted approaches to develop talent, depending on the segment. The role will also partner to ensure we are aligning Talent to Value and diagnosing key talent requirements across the business to inform development focus and opportunities. This role reports to the Global Head of Talent and Growth and is based in Foster City, California. Responsibilities Leads the team responsible for end-to-end yearly talent cycle with a focus on building a system and processes that enable high-performance, learning, growth, and engaged employees. Ensures the continuous improvement and innovation of talent systems, programs, and processes incorporating stakeholder feedback. Leads in the design, execution, and monitoring of the identification, assessment, and development approaches and solutions to improve the depth and capabilities of Gilead's global talent. Manages the talent review, succession planning, and performance process from start-of-year goal setting to end-of-year conversations including the analysis of results and data. Monitors the subsequent assessment and development activities that support the organization in developing an adequate pool of talent. Ensures approach to strengthens management's ability to identify and assess talent and support development planning. Diagnoses critical needs across talent segments and develops innovative approaches to support accelerated development. Partners with HR Business Partners, and People Partners to embed Talent to Value practices and ensure oversight of Value Creating roles. Supports in identifying critical challenges to support and enable success in the role. Works across the Talent, Development and Inclusion COE to ensure talent identification, assessment and development practices are integrated and supported. Monitors the development of key talent and coordinates with HR Business Partners and People partners to have development plans in place and achieved while ensuring readiness for next likely assignment. Takes a key role in the coaching and development planning for key leadership talent. Partners with Talent Acquisition to ensure proactive planning and prioritization for pipelining where key gaps are identified in succession planning and/ or where key roles require. Continually monitors bench strength and ensures plans are in place to address gaps. Expertise 12+ years with BS/BA; 10+ Years with MS/MA or MBA Progressive experience in talent management and/or human capital experience people / leadership development (in either an HR internal role or HR consulting role working directly in Human Capital or Leadership/ talent management consulting) Experience advising and guiding leaders and managers in talent and leadership practices in a global environment. Expertise in designing, integrating, and operationalizing talent management/development across a global organization. Leadership Capabilities Demonstrated ability to build relationships and influence across a matrixed, global organization, responding quickly to change and adapting/operating in ambiguous environment. Ability to leverage data and insights to diagnose, define focus and align opportunities. Takes a proactive, long-term perspective in design and developing approaches to deliver outcomes for the business. Seeks diverse perspectives, experiences and insight; creates an environment of trust and openness. Has a customer focused approach and embeds into mindset, practice and methodology. Excellent oral and written communication skills; able to simplify and integrate complex concepts and ideas. Demonstrates development focus by seeking feedback and acting on it and providing feedback to others. 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. As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 ****************** for assistance. For more information about equal employment opportunity protections, please view the EEO is the Law poster. #J-18808-Ljbffr

A leading biotech company in Foster City is searching for a Senior Scientist with extensive experience in analyzing omics data such as RNA-Seq and WES. The ideal candidate will have a PhD and 8+ years of experience in the pharmaceutical or biotech industry, strong statistics knowledge, and excellent communication skills. Responsibilities include synthesizing scientific questions into research efforts and empowering teams to achieve organizational objectives. Join a dynamic team that values diversity and supports professional growth. #J-18808-Ljbffr

A leading biopharmaceutical company in Santa Monica seeks an Associate Director of Omnichannel Marketing. The role involves developing marketing strategies, overseeing campaigns, and ensuring a great customer experience. Ideal candidates will have 7+ years in marketing and a strong background in omnichannel approaches. Benefits, including competitive salary and stock incentives, highlight the commitment to employee well-being. #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

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

* 15+ years pharmaceutical industry experience including expertise in marketing strategy and tactics and commercial policies and practices* Proven record of leading product launch and brand growth* Knowledge and experience in rare disease or liver disease preferred* Proven experience with pharmaceutical regulatory requirements (OPDP) and impact on development of marketing materials in accelerated approval* Excellent interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines.* Proven strategic capabilities with ability to conceive, develop and implement multidimensional marketing and business plans* Demonstrated excellence in project management and effectively managing multiple projects/priorities* Strong communication skills with experience presenting before executive staff* Firm command of financial management with an understanding of revenue forecasting and expense budget planning and tracking.* Experience managing cross-functional teams or work groups as well as direct reports* Sales/market research experience is preferable, though not required* MBA preferred, Bachelor's degree in marketing or related fields required #J-18808-Ljbffr

A leading biopharmaceutical company in Santa Monica is seeking a Senior Clinical Trials Management Associate to oversee clinical trial operations. The role requires at least 4 years of experience in clinical trials, with a strong preference for candidates experienced in oncology or hematology. Responsibilities include managing clinical trial conduct, communication with contract research organizations, and providing training for trial staff. The position offers competitive salary and benefits, including health insurance and paid time off. #J-18808-Ljbffr

United States - California - Foster City Process/Product Development & Operations Regular The Associate Director/ Principal Scientist , Cell Culture Process Development (Pivotal & Commercial), will be responsible for leading aspects of cell culture development including commercial process development and process characterization for multiple biologics programs during pivotal phases (phases II/III and post-launch). In addition, this role is also expected to lead projects for cell culture process technology development, platform process evolution, and to support cell culture-related regulatory documentation. Key Responsibilities Optimize and characterize cell culture processes to supply pivotal trials and enable commercialization for monoclonal antibodies, multi‑specifics, and novel modalities. Lead and/or support entire lifecycle of pivotal activities including process risk assessment, process characterization, preparation of all supporting documentation/reports toward BLA submission, provide support to ensure successful process performance qualifications (PPQ), and author relevant sections of BLA. Lead and/or support technology transfer and investigation activities in partnership with the global manufacturing sciences and technologies (MSAT) group. Design experiments and perform hands‑on cell culture operations in shake flasks, ambr15, ambr250, bench‑scale bioreactors, and novel cell culture platforms. May provide support to pilot plant operation for up to 500 L single‑use bioreactor. Perform statistical analyses and appropriate modeling to assess process parameter criticality, identify acceptable ranges, and contribute to integrated control strategy. Author and review GMP and non‑GMP technical documents (reports, regulatory submissions/responses, batch records, SOPs etc.), present in group/cross‑functional meetings. Participate and work cross‑functionally within and outside of biologics technical development to achieve common goals. Explore, develop, and implement novel cell culture technologies to meet business needs. Manage direct and indirect reports and mentor junior group members while working in a flexible and agile environment. Some travel may be required to support technology transfers and provide oversight at external manufacturing facilities. Adhere to department budget and all training, compliance and safety requirements. Remain current on trends and new technology advancements across the Biopharmaceutical industry. Hire, mentor and develop team members within the organization to help build and grow a world‑class biologics cell‑culture process development organization. Qualifications Ph.D. with 5+ years OR M.S. with 8+ years OR B.S. with 10+ in a relevant scientific discipline (biology, bioengineering, chemical engineering, biochemical engineering). Experience leading pivotal stage cell culture process development/characterization and implementation in GMP facilities. Experience in building high‑performing teams through strategic coaching and feedback. Hands‑on laboratory operations experience including shake flask, high‑throughput bioreactor, bench scale bioreactor, and pilot scale cultures. Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving. Demonstrated ability to collaborate and influence cross‑functionally. Experience in cell culture media development, and/or employing modeling techniques for upstream process development and optimization is preferred. Experience in statistics, design‑of‑experiments, and data analysis (e.g. JMP, Spotfire). Working knowledge of lab automation, data management, data science, knowledge management and data protection. Experience with viral vaccines is a plus. Passion for inclusion: knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way he/she/they work. #J-18808-Ljbffr