Adverum Biotechnologies jobs - 731 jobs

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 Gilead Sciences is seeking a highly motivated, adaptable, and experienced Program and Project Management leader to start up a new state-of-the-art Single-Use DS Biologics Manufacturing facility in Foster City and integrate this facility with existing Foster City cGMP Manufacturing activities. As the Foster City Manufacturing Operational Readiness Program Lead, you will design, build and manage the multi-year cross-functional program of activities and workstreams involved in transitioning Gilead's new Foster City biologics manufacturing facility from capital project into routine cGMP production. You will help ensure that the systems, people, and processes are in place to support clinical manufacturing and future commercial launches. This is a unique opportunity to shape the future of Foster City Manufacturing for Gilead and make a lasting impact on global health. Job Responsibilities Coordinate the creation of an Operational Readiness Program and reinforce a sense of purpose and ownership among all team members. Structure distribution of responsibilities across multiple workstreams within the program, drive prioritization and sequencing of workstreams, and partner with the Capital Project team to align operational and project timelines, deliverables, and resources. Evaluate industry best practices and select an appropriate program and project delivery model that supports the dynamic nature of a new facility startup and integrates with Gilead's existing governance and delivery frameworks. Select and manage the tools, standards, business processes, documentation, metrics, and communications associated with the Operational Readiness Program. Partner with IT and key stakeholders to pilot and implement innovative digital solutions for the Operational Readiness Program and Foster City Manufacturing. Organize, prioritize, sequence, and track workstreams, activities, and resources necessary for Foster City Manufacturing to support startup and Engineering project deliverables. Work with the Foster City Manufacturing Leadership Team, the Global Manufacturing organization, and senior leaders across PDM to develop a comprehensive Foster City Manufacturing site strategy document and own the portfolio of projects to achieve the site's long-term ambitions. Actively participate in defining and communicating the Foster City Manufacturing mission and vision in alignment with Gilead's corporate values. Act as a change agent to foster an inclusive and high performing organization with a culture of curiosity, continuous improvement, and innovation. Operate with an Enterprise-First mindset and a willingness to adapt and flex across functional boundaries as needed to achieve mission critical tasks. Minimum Required Education, Years of Experience and Qualifications Bachelor's degree in engineering, life sciences, or related field, and 10+ years of experience in biotech/pharma manufacturing or process development with a minimum of 2 years direct or matrixed people leadership experience. OR Masters' Degree and Eight Years' Experience in biotech/pharma manufacturing or process development with direct or matrixed people leadership experience 5+ years of project and portfolio management experience utilizing both traditional and agile project delivery methodologies. Strong understanding of cGMP compliance. Strong business and financial acumen. Proven experience successfully managing cross-functional teams and complex project timelines with significant components of uncertainty. Demonstrated ability to thrive in a dynamic environment and collaborate across diverse technical areas. Experience with Biologics Drug Substance manufacturing equipment and processes, Single-Use Technologies, and cGMP facility qualification and startup preferred. 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. #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

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life‑changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient‑focused and science‑driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. The Medical Science Liaison (MSL) is a member of a field‑based team of scientists who function as an extension of the US Medical Affairs organization. MSLs are responsible for developing and enhancing professional relationships with medical thought leaders involved in various phases of product development. MSLs provide medical information through scientific exchange, and clinical/scientific support for Jazz Pharmaceuticals and the Medical Affairs department. This is a field‑based position covering Maine, Vermont, New Hampshire, Massachusetts, Rhode Island, Connecticut, New York State (minus NYC), Eastern Pennsylvania (Philadelphia territory), and requires professionals with established personal and scientific credibility to interact with thought leaders and academic centres of excellence. Essential Functions KOL Development and Field Engagement Identify and develop peer‑to‑peer relationships with key opinion leaders (KOLs) and healthcare providers within the therapeutic area. Develop and execute territory plans in alignment with US Medical Affairs plans. Identify and communicate key clinical and research issues and insights from KOLs to appropriate departments. Participate in medical education for healthcare professionals (HCPs) through on‑site presentations at healthcare institutions, investigator meetings, national conferences, advisory boards, or regional meetings. Provide scientific support for additional activities such as medical congress staffing, advisory boards, and sales training initiatives. Positions Self as Scientific Expert Maintains an up to date and high‑level knowledge of the therapy area, Jazz products, new and emerging areas of research, therapeutic issues and trends, and competitive landscape. Establishes reputation as a trustworthy and knowledgeable source of scientific and medical information for the healthcare community. Supports development of Jazz Pharmaceuticals positioning as the scientific authority in the therapeutic area. Attends appropriate scientific congresses to stay abreast of developments and to support Regional, National and local KOL activities and Jazz interests. Acquires a broad understanding of local and national protocols and standards of clinical practice and trends in disease management in the US. Provide clinical presentations and information in response to unsolicited questions (as appropriate) in academic, community, and healthcare provider settings in both group and one‑on‑one situations. Communicates emerging data and the clinical experience with our products through scientific exchange and peer‑to‑peer interactions discussing benefits and risks in an objective manner. Provide support for data generation activities (company‑sponsored studies, collaboration studies, ISTs). Provide scientific support for additional activities such as medical congress staffing, advisory boards, and sales training initiatives. Medical Affairs Planning and Plan Execution Contributes to the development of the US Medical Plan and provides input into local strategies and tactics. Works in a collaborative manner with cross‑functional colleagues to ensure a Key Account Management approach. Works collaboratively with cross‑functional colleagues‑including Commercial, Clinical Development, and Market Access‑to ensure a coordinated Key Account Management approach that aligns scientific engagement with broader organisational objectives. Interacts with HCPs as a scientific resource to support activities aligned with the Medical Plan including advisory boards, speaker development and clinical trials. Responsible for maintaining Company standards and Jazz Values Behaves ethically and with integrity at all times. Acts as an ambassador to enhance Jazz Pharmaceuticals' image as an advocate of medical advancement by using knowledge of product, disease state and pipeline products to engage healthcare providers in meaningful scientific exchange of information. Documents and forwards reports of adverse events and product complaints according to Jazz's policy to ensure safe and effective use of Jazz Pharmaceuticals' products. Adheres to the relevant national and local Codes of Practice. Maintains and actively executes a personal development plan aligned with role expectations and career growth objectives. Prepares timely reporting according to the company needs. Required Knowledge, Skills, and Abilities Required Ability to communicate complex scientific and medical information effectively across diverse audiences, adapting content and delivery to match their level of expertise. Clear and concise communication and presentation skills. Excellent planning and organisation skills, with high‑level attention to detail and accuracy. Strong strategic mindset. Highly self‑motivated and ability to work autonomously. Ability to learn quickly, be flexible and results‑focused in a rapidly changing environment. Excellent negotiation skills. Demonstrated skills in inter‑personal relationship building, networking, collaboration and teamwork. Proven track record of effective collaboration with commercial teams, ensuring alignment while maintaining scientific integrity and compliance. Strong capabilities working with digital platforms and tools required. Excellent command of spoken English. Preferred Demonstrated success supporting product launches in a field medical capacity. Experience managing multiple molecules or therapeutic areas simultaneously, with proven ability to prioritise and adapt in a dynamic environment. Track record of effective clinical trial site support, including driving patient recruitment and engagement with investigators. Understanding of regulatory requirements for field‑based personnel. Required/Preferred Education and Licenses Advanced degree (PharmD, MD, PhD or equivalent) with a minimum of 3 years' experience in Oncology or Rare Disease is required. License (RN, NP, CNP, PA or equivalent) with a minimum of a Master's Degree (or equivalent) and a minimum of 5 years' experience in Oncology or Rare Disease clinical practice is required. A minimum of 2 years of experience as an MSL or comparable industry or clinical role is required. Experience in neuro‑oncology is strongly preferred. Experience as a Medical Science Liaison with a strong track record of success is strongly preferred. This is a field position, and applicants must be willing to travel 60‑70% of the time. Valid driver's licence and live within 60 miles of a major airport. Description of Physical Demands Frequent travel between meeting sites. Frequently operating a computer, printer, telephone and other similar office machinery. Description of Work Environment Frequent interactions with external contacts in their office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes. Frequent computer laptop or tablet use, not usually at a workstation. Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands. Frequent public contact requiring appropriate business apparel. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $154,400.00 - $231,600.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz. Click apply for full job details. #J-18808-Ljbffr

Senior Corporate Counsel, Contracts page is loaded## Senior Corporate Counsel, Contractslocations: Alameda, CAtime type: Full timeposted on: Posted Todayjob requisition id: JR6460**SUMMARY/JOB PURPOSE:**The Senior Corporate Counsel, Contracts takes a supporting role in setting the material terms of the many business transactions undertaken by the company, the drafting and negotiation of definitive and ancillary agreements reflecting those terms, and the organization of processes necessary and helpful for Exelixis to transact efficiently and effectively. This function also plays a transactional oversight role, working with Legal and operational colleagues to help ensure that the company's R&D activities and transactions are carried out with efficiency and reflect an appreciation for an appropriate level of business and legal risk.**ESSENTIAL DUTIES AND RESPONSIBILITIES:*** Drafts, reviews, and negotiates a wide range of contracts with a very high degree of independence in support of the Research and Development organizations (which may include confidentiality agreements, collaboration agreements, licensing agreements, consulting agreements, materials transfer agreements, simple and complex clinical trial agreements, clinical advisory board agreements, and various vendor services agreements, and manufacturing agreements for cGMP drug supply).* Acts as a legal point person for ongoing agreements in support of R&D efforts.* Reviews redlines, supervises negotiations and provides general guidance to junior attorneys and contracts managers.* Assists with maintaining up-to-date form agreements consistent with industry standards and applicable laws.* Identifies and defines operational and legal risks and is able to communicate those risks to appropriate internal decision-makers for discussion and resolution.* Cultivates strong and highly effective cross-functional relationships and communication with internal colleagues to effectively address legal and business questions.* Effectively represents the company.* Handles miscellaneous legal tasks on an as-needed basis.**SUPERVISORY RESPONSIBILITIES:*** No supervisory responsibilities but may provide direction to other individuals.**EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:****Education:*** BS/BA degree, preferably in life sciences or a related field; an advanced life science degree is preferred.* JD degree is required and a minimum of six to eight years of relevant experience.* Must be admitted to practice law, preferably in California.**Experience:*** Experience as an attorney in a law firm or in-house legal environment in biotechnology or pharmaceutical industry.* Complex contract drafting and negotiation experience required, including a significant volume of contracts in support of drug Research & Development activities.**Knowledge/Skills:*** Possesses clear and concise verbal and written communication skills and must have excellent interpersonal communication skills.* Strong computer skills (e.g., Microsoft Office Suite (Word, Excel, PowerPoint, etc.), document management systems, and redlining software).* Must be detail-oriented and have strong organizational skills.* Ability to handle multiple tasks simultaneously, with the ability to re-prioritize on short time frames. Can quickly separate the mission-critical from the nice-to-haves and the trivial.* Ability to make complex decisions based on the data available; drives to the finish on all projects.* Acts responsibly and conscientiously.* Works under pressure to meet specific deadlines.* Works well both independently and in a team environment; addresses differences fairly and equitably; treats everyone as a preferred internal client.* Dedicated to quality, reliability, and highest professional standards in all work tasks.* Must be a self-starter and quick learner.* Must have good judgment.**WORKING CONDITIONS:*** Primarily working indoors, in an office environment#LI-HG1*If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!*### ### Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $222,000 - $316,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.### **DISCLAIMER** The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.***We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.***Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial. As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission. Cancer is our cause. Make it yours, too. #J-18808-Ljbffr

* Performs as a leader within Global External Manufacturing to execute the network strategy. Responsible for tactical manufacturing strategy, execution of the business with external manufacturing organizations, and management of supplier performance* Partner in development of department strategy aligned with corporate and PDM goals into functional/departmental objectives to realize the targeted outcomes* Proactively and effectively leads collaboration with functions within and external to PDM to achieve corporate, cross functional, and departmental goals* In collaboration with Technical Development Organization, defines the technical requirements and actively partners with Global Supply Chain in selection of CMOs, and influences overall performance of the network CMOs to achieve Gilead's strategic and tactical business outcomes, including Key Performance Indicators* Proactively partners with Technical Development and internal Gilead manufacturing sites for successful technology transfer and validation of new or existing processes/products to the identified CMO(s)* Leads the regular, tactical management of CMOs to ensure Gilead's products are manufactured in accordance with the registered process and approved Master Production Record* Enables timely resolution of complex issues associated with manufacturing and/or compliance, including handling of deviations, complaints, out-of-specification investigations, Material Review Board associated investigations, finished product trending, and change control* Fosters and facilitates continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability* May represent Gilead as a liaison between the company and various governmental agencies as required* Demonstrated track record in oral solid dosage drug product manufacturing and supply chain execution in the pharmaceutical industry* Expertise in supply risk management, possessing in-depth knowledge of industry and system best practices* Experience and/or working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP). Solid knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance* Solid understanding of the contract manufacturing organization (CMO) landscape; knowledge of CMO capabilities and limitations for worldwide drug product manufacturing is a plus* Ability to travel internationally, including overnight, up to 10% of the time is required* Exceptional verbal and written communication skills, including ability to interact effectively with senior management* Demonstrated ability to understand and resolve complex situations* Proven leadership capability to contribute to the success of PDM and Gilead* 12+ years of progressively responsible experience in a pharmaceutical/biotech organization and a BA or BS degree in science or engineering, an advanced degree in science, engineering, or business is desirable* An MBA degree can be substituted for 10 years of relevant experience, a Ph.D. degree can be substituted for 8 years of relevant experience #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

Director, Comparator Sourcing, Global Clinical Supply Chain (GCSC) Director, Comparator Sourcing, Global Clinical Supply Chain (GCSC) United States - New Jersey - Parsippany, United States - California - Foster City Manufacturing Operations & Supply Chain Regular The Director, Comparator Sourcing, Global Clinical Supply Chain ( GCSC) is responsible for providing leadership over the comparator sourcing strategy and timely delivery management. This Director, Comparator Sourcing, GCSC will effectively manage relationships with vendors and Procurement as needed and acts as the point escalation for the planning organization on issues for comparator provision. As a key contributing member of the GCSC Leadership Team (GCSC LT), you will ensure strategic alignment to Gilead's development portfolio and strategic goals as well as build strong relationships with Gilead functional leadership (including and not limited to Clinical Supply Planning and Management (CSPM), Clinical Operation, Regulatory, Quality and the rest of PDM) to ensure alignment of the organizations and prompt resolution of critical issues. You are considered an expert, with working knowledge of supply chain best practices and experience working with a GxP environment. The Director, Comparator Sourcing, GCSC has a strong cross-functional, multi-cultural awareness and communication skills to lead in a fast-paced, global company. Focus Areas: Oversees the collaboration with CSPM and other cross-functional teams to understand the comparator requirements for clinical studies. Develops efficient, effective and compliant sourcing strategies to deliver the comparators on time in full. The sourcing strategies are measured based on maximizing supply efficiency, minimizing waste while identifying risks and developing as well as communicating risk mitigation plans. Partners with Procurement, Quality and Regulatory for the identification, qualification and management of comparator sourcing vendors in support of Gilead's portfolio. Builds an infrastructure for the collection of comparator information, ensuring resident expertise is established for types of comparators on the market, including pack sizing. Ensures on time responses between the vendors, Procurement and CSPM in support of delivery for the required comparators on time. Ensures support is provided to CSPM and other key stakeholders in providing supporting documentations for the comparators - e.g. SmPC, product specs, etc. Ensures tracking of target of delivery to CMOs support release activities. Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure - e.g. time of environment (TOE), temperature excursions, etc. Responsible for informing and/or escalating market recalls, withdrawals and safety alerts as related to sourced comparators. Builds strategic relationships with internal functional groups and ensures alignment. Participates or leads process improvement initiatives cross functionally with stakeholders contributing to global/regional initiatives or programs. Participates in CD&OP reviews, presents comparator supply delivery performance and facilitates related discussions as required. Ensures robust systems and processes are in place to enable execution of operational and logistical tasks in a GxP compliant manner. Collaborates and authors department policies and procedures. Basic Qualifications: Advanced scientific degree (i.e., PhD) and 8+ years of supply chain experience in the biotech/pharmaceutical industry OR Master's Degree and 10+ years of supply chain experience in the biotech/pharmaceutical industry OR Bachelor's Degree and 12+ years of supply chain experience in the biotech/pharmaceutical industry Preferred Qualifications: Bachelor's degree in Supply Chain, Business, Science, or Engineering discipline. Master's degree and/or professional qualifications in Supply Chain Management desired. 12+ years progressive experience in supply chain, preferably within biotech, pharmaceutical, CRO industry with 5+ years in comparator sourcing. Experience working in a global, complex supply chain organization within the biopharma industry. Experience building and leading teams from multi-disciplinary departments. Strong ability to collaborate and build strategic relationships with internal stakeholders - Clinical Operations, Quality, Regulatory, CMC, etc. Demonstrates advanced knowledge of global clinical trials and the drug development process. Experience in vendor oversight and managing external partnerships and relations. Experience with comparator sourcing. Understanding of IRT system functionality and forecast modeling. Awareness of comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, ICH/GDP, GCP, 21 CFR Part 11 and EU CTR Annex VI, etc.). Experience in deviation investigation and CAPA implementation. Ability to work effectively in cross-functional and multi-cultural teams. Gilead Core Values Integrity (Doing What's Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) Share: Job Requisition ID R0045026 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 a US Medical Senior Director to drive evidence generation strategies and lead medical oversight for clinical trials. The ideal candidate has an MD and at least five years of experience in medical affairs within the biopharmaceutical industry. Responsibilities include strategic planning, study oversight, and cross-functional collaboration to enhance cancer therapies. #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

United States - California - Foster City Manufacturing Operations & Supply Chain Regular KEY RESPONSIBILITIES Reporting to th e Senior Director , Pharmaceutical Development and Manufacturing (PDM) Operations Management , the Director , PDM Infrastructure will lead the team responsible for the key non-GMP systems that have an outsized impact on how we store, find and access non-GMP information in PDM. SharePoint ( G.Share ) and PDM apps like the PDM Team Rostering application ( G.Force ) will the initial areas of focus. PDM has generated a great deal of important non-GMP information ; being able to find and access such information easily and consistently across PDM will improve efficiency and speed . Success in this role depends on ongoing solicitation of feedback from PDM stakeholders and continuous improvement . FOCUS AREA S Lead the G.Share Sites and G.Share Business Apps teams Assess and prioritize current non-GMP infrastructure for knowledge sharing and identify areas for continuous improvement Serve as a member of the PDM Operations Management Leadership Team , connecting work that the PDM Infrastructure team does with the broader PDM Operations Management strategy Implement strategy and plan for enabling more efficient and consistent access to non-GMP information across PDM , making it easier and more efficient for PDM staff to get their work done Work effectively with partners in I T, with clearly defined roles & responsibilities. This role is not a technical systems role; it is the business side of information infrastructure and access BASIC QUALIFICATIONS: A degree in life sciences or a relevant business area with 12+ years of varied post-graduation experience in Pharmaceuticals, Biosciences or a related industry. Or MS with 10+ years of relevant experience. Or PhD with 8+ years of relevant experience. Strong business acumen, with demonstrated capability to translate information infrastructure to improved efficiency Strong experience with SharePoint and web-based information storage and access Demonstrated capability to navigate and lead in a highly networked environment and experienced with the required elevated level of influencing skills. Elevated communication skills, both written and oral. Strong presenter capable of engaging with, and facilitating conversations with, the senior leaders in the organization. Negotiation and conflict resolution skills. Experience developing, implementing, and executing strategic plans and objectives for departments, especially in a highly networked environment. Solid understanding of current industry trends. Experience leading a non-technical team that interfaces with technical teams Leadership qualities of the successful candidate include the following: collaboration, accountability, cross-functional engagement and influence, program management, strategic vision, goal setting and performance management. PREFERRED QUALIFICATIONS: Demonstrated capacity to understand complex problems and to implement solutions that are as simple as possible. Experience with knowledge management 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. Job Requisition ID R0046747 Full Time/Part Time Full-Time Job Level Director #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

* Depth of experience in the pharmaceutical/biotechnology industry, having held leadership roles in the US and outside the US.* Previous full P&L responsibility and financial success as a GM (or GM-equivalent) across large market(s) and cluster(s)/region(s).* Expertise in global product strategic planning, tactical marketing, commercial policies and practices, new product planning, portfolio management and lifecycle management* Proven general management, with enterprise mindset and strong people leadership: ability to lead change, inspire followership, motivate, and develop a team, possessing excellent interpersonal skills to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures and disciplines.* Global mindset and experience, including experience in emerging markets and passion for resource-limited countries. Globally aligned and locally relevant decision-making. Ability to navigate the matrix and influence/negotiate from a lower priority position.* Track record of successfully working with the relevant government/public agency and health authorities* A ‘leader of leaders' with previous experience leading a global team, preferably in complex and matrixed environments. Demonstrated ability to structure and oversee large-scale, complex partnerships. Lead & drive competitive fitness and overall accountability within geographically and culturally diverse cross-functional workforce.* Direct experience in strategic planning and strategic marketing in HIV, Hepatitis, CV, and/or Oncology products is preferred* Travel Requirement: 30-40%* The preferred location for this position is Foster City, CA; Stockley Park, UK is a secondary however less-preferred option.* >18 years' experience in the pharmaceutical/biotechnology industry* Minimum of 7 years' experience with full responsibility for P&L and proven financial success as a GM (or GM-equivalent) across large, global market and/or cluster.* Bachelors/Advanced degree 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 a 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. #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

Adverum is a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the capabilities of its proprietary intravitreal platform, Adverum is developing durable, single-administration therapies, designed to be delivered in physicians' offices, to eliminate the need for frequent ocular injections to treat these diseases. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. Additionally, by overcoming the challenges associated with current treatment paradigms for debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe. Note to Recruiters and Agencies All recruiter and agency inquiries must go through Adverum's internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered property of Adverum. Agencies must be expressly engaged by Adverum's Talent Acquisition team for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future. At Adverum, we're always excited to meet people who share our mission. If you don't see a role that fits today, share your details-we're always looking to connect with those who believe that great science starts with great people. At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space that allows for everyone in our Adverum Community to not only feel safe but also encouraged to speak, learn from each other, grow in their professions, and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation.

A leading biotechnology firm in Alameda seeks a Director of Statistical Programming Standards & Infrastructure to lead development of programming standards and tools across studies. The role demands extensive experience in statistical programming, collaboration with various teams, and solid understanding of regulatory compliance. Candidates should possess a BS/BA and have a proven track record in enhancing efficiency in programming workflows. Competitive compensation package offered, including bonuses and comprehensive benefits. #J-18808-Ljbffr

A biotechnology company is seeking a Medical Science Liaison to develop peer relationships with thought leaders and provide scientific support. This field-based position covers multiple states and requires expertise in medical communication and oncology. Candidates must possess an advanced degree and relevant experience in medical science, along with the ability to travel frequently. The role involves leading educational initiatives and supporting product launches, ensuring alignment with the medical affairs strategy. #J-18808-Ljbffr

**SUMMARY/JOB PURPOSE (Basic purpose of the job):**The Senior Director IT Product Management, SAP Platform, will oversee and lead a portfolio of digital products critical to Exelixis's success and ambition to launch innovative medicines for patients. This role is pivotal in defining and driving the strategy, development, and operational excellence of our Enterprise Resource Planning ecosystem, ensuring alignment with business objectives and a strong focus on user experience and value delivery. Operating within a product-centric model, the Senior Director will be responsible for defining product roadmaps, fostering cross-functional collaboration, and leading agile product teams to deliver innovative and impactful digital solutions that accelerate drug discovery, development, and commercialization.**ESSENTIAL DUTIES/RESPONSIBILITIES:**Champion a user-centric design approach, leveraging user research, usability testing, and feedback loops to continuously improve the user experience and effectiveness of enterprise solutions across multiple enterprise products and business functions.Define and enforce all enterprise applications, feature releases and processes comply with relevant regulatory requirements (e.g., GxP, HIPAA, GDPR, SOX) and internal quality and security standards.Ensure that all product releases meet rigorous quality standards and compliance requirements. Partner with quality and compliance leaders to re-define and update standards as needed.**SUPERVISORY RESPONSIBILITIES:** **EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:** **Education:** Bachelor's degree in related discipline and 15 years of related experience; or Master's degree in mathematics or statistics or engineering and 13 years of related experience.PhD degree in a related discipline and 12 years of related experience; or Equivalent combination of education and experience. **Experience/The Ideal Candidate will have:** Minimum of 10 years of experience supporting Enterprise IT enabling business functions.Minimum of 12+ years of progressive experience in IT, with at least 8+ years in a leadership role focused on enterprise applications or product management within the life science or pharmaceutical industry.Proven experience in leading product development teams in an agile/product-centric operating model is essential. Experience managing and implementing supply and demand planning solutions (e.g. Kinaxis) Experience with integration platforms, such as CPI (Cloud Platform Integration), Integration Suite or other similar middleware Experience with regulatory frameworks and compliance in a SOX and GxP environment including IT General Controls (ITGC) and Segregation of Duties (SoD).**Knowledge / Skills:** Exceptional leadership and team-building skills, with the ability to inspire and motivate diverse teams. Strong strategic thinking and problem-solving abilities, with a data-driven approach to decision-making. Excellent communication, presentation, and interpersonal skills, with the ability to influence and collaborate effectively at all levels of the organization. Solid technical acumen with the ability to understand complex IT architectures and development processes. Ability to manage multiple priorities in a fast-paced, dynamic environment. Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial. As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission. Cancer is our cause. Make it yours, too. #J-18808-Ljbffr