Post job

Myriad Genetics jobs in South San Francisco, CA - 757 jobs

  • Computational Scientist II - Scientific Affairs

    Myriad Genetics & Laboratories 4.7company rating

    Myriad Genetics & Laboratories job in South San Francisco, CA

    As a Computational Scientist in Scientific Affairs, you will work at the interface of product development and evidence generation to advance the performance, clinical adoption, and patient access of Myriad's products. You will use your computational biology expertise, in collaboration with internal R&D and clinical teams, to carry out studies using Myriad's Precise MRD, as well as other existing or nascent technologies/products. Your focus on quality and innovation will be critical to Myriad's successful partnerships with leading academic centers and biopharma companies and will help our products reach their full potential. Location: Remote (Bay Area/ South San Francisco preference) Minimum- Midpoint compensation (for Bay Area): $132,625.00 - $165,750.00 Responsibility * Analyze data from research and biopharma studies, present results to internal stakeholders and to external partners, and ensure successful completion of the studies. * Develop custom analysis algorithms and pipelines with good testing and documentation practices. * Distill learnings from research and clinical data to identify areas of improvement in our assays, and as appropriate, actively implement those improvements. * Author and review scientific manuscripts, abstracts, and conference presentations to communicate key findings and innovations from Myriad's research efforts. * Use technical expertise to stay current with advancements in genomics, bioinformatics, and oncology, ensuring Myriad remains at the forefront of diagnostic innovation. Qualifications * PhD with 2+ years of industry experience in applying genomic technologies for clinical applications or product development. * Proficient computational skills in Python and use of software-engineering best practices; familiarity with R for statistical analysis and data visualization is a plus. * Demonstrated experience developing analysis methods, algorithms, and pipelines, particularly with next generation sequencing (NGS) data. * Demonstrated critical scientific thought, independent problem solving and excellent technical communication skills. * Working knowledge of nucleic acid chemistry and genetics. * Preferred experience in R&D with non-invasive technologies, oncology, and regulated clinical diagnostic products (CLIA, FDA). EEO We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.
    $132.6k-165.8k yearly Auto-Apply 26d ago
  • Job icon imageJob icon image 2

    Looking for a job?

    Let Zippia find it for you.

  • Sr Computational Scientist

    Myriad Genetics & Laboratories 4.7company rating

    Myriad Genetics & Laboratories job in San Francisco, CA

    The Sr Computational Scientist builds and maintains the underlying assays and analytical pipelines, working closely with molecular biologists and software engineers. Contributions include validating product updates, developing statistical analysis methods, and sharing methods in the form of simple re-usable software. Location: Hybrid South San Francisco RESPONSIBILITIES * Make critical contributions to awesome products in a cutting-edge clinical genomics laboratory. * Use rigorous data science and modern software best practices to create efficient, reliable, and optimized bioinformatics pipelines. * Lead project teams that build, validate, and future-proof new products and product features. * Work closely with talent molecular biologists, software engineers, automation engineers, and data scientists. * Characterize data resulting from novel molecular assays and guide molecular protocol development from a statistical perspective. * Mentor junior scientists and research associates, guiding the overall path and success of key projects. * Author posters and publications demonstrating the scientific prowess of our products and algorithms that power the products. * Work with legal staff to secure intellectual property rights for inventions pertaining to our products. * Communicate results to stakeholders across the organization. QUALIFICATIONS * PhD in Computational Biology, Statistics, Molecular Biology, Genetics, Computer Science, Systems Biology, Biophysics, Physics, or a related discipline. * 5+ years of experience developing methods to analyze large, noisy real-world data sets (in the context of molecular biology and/or human genetics, a plus). * Experience leading multi-departmental projects and mentoring junior scientists and research associates. * Experience developing custom analysis methods and algorithms and analysis pipelines. * Experience working with CLIA-validated assays and authoring CLIA validation plans, Illumina Next Generation Sequencing (NGS), and other sequencing platforms. * Strong computation skills, fluency in Python and a workflow definition language, and knowledge of software engineering best practices. * Multiple peer-reviewed publications. * Experience with modern medical genetics data sets preferred. * Working knowledge of nucleic acid chemistry and genetics preferred. * A sense of humility coupled with deep compassion, impeccable integrity, and an eagerness to be part of a caring and supportive team. Applicant must be a (i) U.S. citizen or national, (ii) U.S. lawful, permanent resident (aka green card holder) Minimum $176,000 and Midpoint $220,000 in the Bay Area. We take geographic location into account when determining base salary to ensure equitable and competitive compensation. Ready to make a difference in the world of genomics? Apply now or share with someone who'd be a great fit! ABOUT US Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: maintaining leadership in an expanding hereditary cancer market, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: *************** #ComputationalBiology #Bioinformatics #GenomicsJobs #ClinicalGenomics #NGSJobs #MolecularBiology #DataScienceJobs #BiotechCareers #SeniorScientist #PythonJobs #StatisticalAnalysis #PrecisionMedicine #HiringNow #TechJobs #ScientificJobs #LI-KO1 EEO We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs. Myriad Genetics is an inclusive work environment and welcomes all applicants. If you need assistance submitting your application due to a disability, you can request an accommodation by contacting *********************.
    $176k-220k yearly Auto-Apply 29d ago
  • Assoc Director, Manufacturing Operational Readiness

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    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
    $130k-167k yearly est. 4d ago
  • Senior Oncology Bioinformatics Scientist

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    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
    $88k-133k yearly est. 2d ago
  • Cell Culture Process Development Lead - Pivotal & Commercial

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    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
    $92k-120k yearly est. 4d ago
  • Senior Corporate Counsel, Contracts

    Exelixis, Inc. 4.9company rating

    Alameda, CA job

    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
    $222k-316k yearly 5d ago
  • Executive Director, Oncology BD & Evaluation

    Exelixis, Inc. 4.9company rating

    Alameda, CA job

    A leading biopharma company is looking for a Senior Business Development Search & Evaluation Director in Alameda, CA. This role involves sourcing and evaluating partnerships in oncology, building relationships in biopharma and academia, and leading due diligence. Ideal candidates will have extensive experience in oncology, relationship management, and negotiation skills, along with a strong educational background in life sciences. The position offers a competitive salary and comprehensive benefits. #J-18808-Ljbffr
    $197k-279k yearly est. 1d ago
  • Director, Global External Manufacturing, OSD

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    * 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
    $133k-182k yearly est. 5d ago
  • Director, Cloud Platform & Automation

    Exelixis, Inc. 4.9company rating

    Alameda, CA job

    A leading biotech company located in California is seeking a Director of Cloud Engineering. This role involves leading cloud product management initiatives, overseeing AWS infrastructure, and driving product strategies that align with the company's mission to innovate medicines. The ideal candidate will possess significant experience in IT leadership, ideally within a biopharma context, and have a proven track record in AWS and product management methodologies. Competitive compensation and a collaborative work environment are offered. #J-18808-Ljbffr
    $200k-274k yearly est. 4d ago
  • Senior Staff Engineer, Client Technology (Intune/SCCM)

    Exelixis, Inc. 4.9company rating

    Alameda, CA job

    A leading biotech company is seeking a Senior Staff Engineer - Client Technology positioned in Alameda, California. This senior role involves overseeing IT platforms, driving product strategy, and delivering scalable solutions. Candidates should have extensive experience in technical leadership, strong scripting skills, and the ability to coordinate cross-functional initiatives. A competitive compensation package includes a salary range of $149,000 - $212,000 and comprehensive employee benefits. #J-18808-Ljbffr
    $149k-212k yearly 5d ago
  • Associate Director/Principal Scientist

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    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
    $116k-163k yearly est. 4d ago
  • Director, Comparator Sourcing, Global Clinical Supply Chain (GCSC)

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    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
    $158k-212k yearly est. 5d ago
  • Lab Supervisor (A2)

    Myriad Genetics 4.7company rating

    Myriad Genetics job in South San Francisco, CA

    Myriad Genetics is a trailblazing genetic testing company that has helped millions of patients make critical healthcare decisions. Myriad Women's Health is a leader in genetic screening. Our tests provide actionable information, empowering women and their families to make critical and timely healthcare decisions. Our laboratory in South San Francisco specializes in molecular prenatal screening of expectant mothers and fathers. Utilizing our highly automated liquid handling platform, our energetic team of dedicated scientists and engineers work together to ensure our industry leading assays produce high quality, life changing results for our patients in a timely manner. If you are motivated and dedicated to improving yourself and your community and would like the opportunity to positively impact people's lives worldwide, we would like for you to join our dynamic and growing team. The Supv CLIA Lab guides, mentors, and directs our laboratory staff comprised of licensed and non-licensed individuals. The Supv CLIA Lab collaborates with laboratory management and fellow supervisors to ensure adequate laboratory staffing and efficient workflows. This position works to develop current team members and identify external talent to build up and strengthen our high performing team in a fun, supportive, diverse, and developmentally focused environment. While mostly a leadership role, the Supv CLIA Lab spends some time in the lab working with our highly automated testing platform to process patient samples. Shift: Sunday-Wednesday 11:00am-9:30pm Responsibility Each employee's specific job responsibilities are uniquely defined by their individual training plan and assigned duties, but are generally defined as follows: Conduct daily supervision and oversight of laboratory staff and operation. Provide feedback and mentorship to direct reports. Monitor the training of laboratory personnel. Perform competency evaluations of laboratory personnel. Provide new employee orientation to new laboratory personnel. Assign laboratory responsibilities to personnel to ensure all tasks are properly performed. Work with our engineering team to troubleshoot instrument issues. Ensure all procedure deviations or instrumentation malfunctions and associated corrections are properly documented. Identify and report problems that may adversely affect test performance or reporting of test results. Ensure adherence to the laboratory's quality control policies. Assist with maintenance and updating of standard operation procedures. Communicate needs from the lab with employees from other departments. Work with the leadership team to assure compliance with applicable regulations. Process patient samples using our automated platform using independent judgement with minimal supervision. Perform setup, teardown, and preventative maintenance on laboratory equipment. Qualifications Meets minimum regulatory education, licensure, and experience requirements: Valid Clinical Laboratory Scientist (CLS) license or Clinical Genetics Molecular Biology Scientist (CGMBS) license issued by the State of California. Bachelor's, master's, or doctoral degree in medical technology or a chemical, biological, or clinical laboratory science. The following years of licensed experience in a high complexity testing clinical laboratory: Bachelor's: 4 years (6 years preferred) Master's: 2 years (4 years preferred) Doctoral: 2 years Experience in a clinical laboratory supervisory or leadership role preferred. The ability to accurately pipette. Strong analytical skills. Excellent verbal and written communication skills. Demonstrated proficiency in computer skills, such as word processing, statistical analysis, and laboratory information systems. A strong understanding of good laboratory practices and regulatory compliance. The ability to adapt and be flexible in a fast-paced and evolving work environment. Preferred: Prior experience with polymerase chain reaction (PCR)-based and/or next-generation sequencing (NGS) methods. Physical Requirements Lifting Requirements - light work or exerting up to 20 pounds of force frequently. Physical Requirements - stationary positioning, moving, operating, ascending/descending, communicating, and observing. Use of equipment and tools necessary to perform essential job functions. EEO We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.
    $61k-77k yearly est. Auto-Apply 20d ago
  • Global Trade Compliance Director - Lead & Expand Program

    Exelixis, Inc. 4.9company rating

    Alameda, CA job

    A leading biopharmaceutical company in California seeks a Director, Global Trade Compliance to oversee its trade compliance and logistics. The role involves leading compliance efforts, managing customs and global logistics, developing policies, and conducting training. Candidates should hold a relevant degree with extensive experience in trade compliance, and possess strong communication and leadership skills. Competitive compensation and comprehensive benefits are offered. #J-18808-Ljbffr
    $149k-199k yearly est. 3d ago
  • Research Associate I

    Myriad Genetics 4.7company rating

    Myriad Genetics job in South San Francisco, CA

    Job Schedule: Full time Responsibilities Conduct and/or support research experiments under the supervision of a Scientist. Conduct lab experiments/research to support and/or advance products, services and technology from initial feasibility through final protocol optimization, application testing and stability studies. Method development and preparing SOPs as needed. Procure chemicals, materials, and reagents. Handle and prepare chemicals and biochemical reagents to perform experiments and develop methods and procedures. Dispose of chemical/biological waste properly; maintain records as appropriate. Calibrate and maintain scientific instruments and laboratory equipment. Maintain an organized, detailed, and accurate record of all experimental procedures and data. Data analysis including excel, tableau, flow cytometry, and image analysis. Provide project status reports. Review literature and apply advanced knowledge. Qualifications BS or higher degree in Biology, Chemistry, or related science with 0-10 years of experience in a research environment (preference for at least 3 years). Experience must include performing experiments in areas such as Next Generation Sequencing (NGS), RT-qPCR, fluorescence spectroscopy, biomolecule conjugation, immunoassays, data analysis, and image analysis. Demonstrated ability to plan, execute, analyze, and document research experiments. Proficient in the use and maintenance of instrumentation for chemical and spectroscopic analysis, such as fluorescence spectroscopy, flow cytometry, UV-VIS, etc. Organized, flexible, and able to multitask in an environment with aggressive timelines. Ability to make experimental observations with a great attention to detail. Ability to pipette is required. Familiarity with liquid handling systems recommended, but not required. Strong written and verbal communication skills. Position requires frequent communication in the form of verbal updates, reports, technical meetings, and presentations. #LI-LP1 About UsMyriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: maintaining leadership in an expanding hereditary cancer market, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: ************** . WE ARE AN EQUAL OPPORTUNITY EMPLOYER. Applicants and employees are considered for positions and are evaluated without regard to mental or physical disability, race, color, religion, gender,national origin, age, genetic information, military or veteran status, sexual orientation, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved. Please answer all questions completely. Please do not provide any information not specifically requested on this Employment Application form. Apply Here: ************************************************** PI182320066 Additional Information All your information will be kept confidential according to EEO guidelines.
    $51k-64k yearly est. 60d+ ago
  • Head of Statistical Programming Standards and Infrastructure

    Exelixis, Inc. 4.9company rating

    Alameda, CA job

    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
    $136k-174k yearly est. 2d ago
  • Senior IT Product Lead: SAP Platform & Enterprise Solutions

    Exelixis, Inc. 4.9company rating

    Alameda, CA job

    A leading biotech company is seeking a Senior Director of IT Product Management to oversee a portfolio of digital products. This role demands strategic thinking, strong leadership, and expertise in enterprise applications within the life science sector. Responsibilities include driving product strategy, ensuring compliance with regulatory standards, and enhancing user experience. The ideal candidate will have extensive experience in IT leadership and product management. #J-18808-Ljbffr
    $145k-195k yearly est. 5d ago
  • Executive Director, Clinical Data Acquisition

    Exelixis, Inc. 4.9company rating

    Alameda, CA job

    Executive Director, Clinical Data Acquisition page is loaded## Executive Director, Clinical Data Acquisitionlocations: Alameda, CAtime type: Full timeposted on: Posted 30+ Days Agojob requisition id: JR6341**SUMMARY/JOB PURPOSE** **(Basic purpose of the job):**The Executive Director, Clinical Data Acquisition (CDA) is accountable for managing a team focused on the strategic and operational leadership of quality data collection activities across all clinical studies Phase I to IV. This includes, but is not limited to, the development and maintenance of policies, procedures, and data standards, maximizing usage of Electronic Data Capture (EDC) systems to ensure timely and high quality data collection, and proactive management of external vendors delivering clinical data using controlled, compliant, and secure methods. The Executive Director, CDA is accountable for the hiring, training, development, and management of employees within the departmental scope, to meet current and future business needs.This incumbent must be capable of representing Clinical Data Management (CDM) and Data Science & Biometrics (DSB) in a leadership capacity. The role requires strong partnership and close collaboration with senior functional and matrix leaders across the R&D organization to ensure the successful, efficient, high quality, and compliant work delivery supporting the company portfolio.**ESSENTIAL DUTIES/RESPONSIBILITIES:*** Responsible for defining, and driving, the vision for optimized data collection that capitalizes on the latest technologies, is compliant with global regulatory requirements & guidances, and results in timely high quality clinical data generation.* Ensure end-to-end management of all CDA activities including, but not limited to, company data standards, eCRF development, external data transfers/integration and reconciliation, and appropriately ensuring validation of clinical data systems and data repositories.* Provide day-to-day leadership of the CDA team (employees, contractors, functional service providers) to instill a work ethic focused on proactive engagement and thought partnership with other roles in CDM and DSB, Information Technology, Strategic Sourcing & Procurement, Development Operations, Clinical Development, Global Patient Safety, and beyond.* Maintain oversight of record retention strategies for clinical data and associated documentation in accordance with all applicable global regulations, company policies & procedures, and study-specific needs. This includes, but is not limited to, archival of clinical data at investigational sites, decommissioning of EDC systems, and contemporaneous storage of documentation in study-specific and/or system-specific document repositories (e.g. eTMF).* At the study and portfolio level, proactively drive quality, efficiency, and innovation to ensure data collection deliverables are met within the established timelines, budget, and quality/compliance standards (e.g. providing input to protocol design, database design, and validation, and data management plans, including data review strategies and data quality assurance).* Establish, and/or provide leadership in, governance structures working with relevant vendors including, but not limited to, data management vendor(s), sample management vendor(s), to ensure effective quality oversight of vendor deliverables and relationships supporting the company portfolio.* Lead data standardization initiatives to ensure data collection methods comply with regulatory requirements, industry standards (e.g. CDISC), company policies & procedures, portfolio-level standards, and the practical needs of individual studies.* Develop and implement a continuous process improvement strategy by monitoring key performance indicators, metrics, quality, and timeliness of study deliverables across the portfolio.* Drives cross-functional senior leadership engagement to develop and deliver solutions for new service capabilities.* Contribute to the development of departmental and study budgets, proactively managing budget, including accurate forecasting and cost accruals.* Proactively identify and troubleshoot operational problems, issues, and obstacles, that help study teams to remove barriers to execution.* Support study teams during submission, inspection, and other regulatory-related activities including, but not limited to, developing oversight processes, creating storyboards, presenting issues and mitigations.* Strong customer focus and belief in Exelixis values; creating a positive value-based work environment for the CDA team. Able to lead, inspire and influence team/organization through rapidly changing business challenges.* Stay current with regulatory and industry advances through cultivation of a wide external network. Able to represent Exelixis in data management, data strategy and other related capacities. Helps establish and maintain Exelixis CDM as an industry leader.* May perform day-to-day tactical responsibilities to ensure successful execution of clinical studies across the company portfolio.**SUPERVISORY RESPONSIBILITIES:*** Directly and indirectly supervises employees.* Responsible for the growth and development of all CDA employees.* May indirectly supervise employee(s) through a dotted line structure.**EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:****Education:*** BS/BA degree in related discipline and a minimum of 18 years of related experience; or,* MS/MA degree in related discipline and a minimum of 16 years of related experience; or,* PhD in related discipline and a minimum of 15 years of related experience; or,* Equivalent combination of education and experience.* May require certification in assigned area.**Experience:*** Typically requires a minimum of 18 years of related experience and/or a combination of experience and education/training.* Experience in Biotech/Pharmaceutical industry required.* Experience in Oncology clinical trials is preferred.* Experience leading major change initiatives is preferred.* Demonstrated experience leading global data management and/or technical teams is required.* Experience participating in regulatory submissions and inspections is required.* A minimum of 12 years of line management experience is required.**Knowledge, Skills and Abilities:*** Has extensive experience in relevant industry/profession.* Excellent understanding of clinical development, quality and regulatory standards (e.g.CDISC) and policies relevant to data management (e.g. GCP, ICH).* Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.* Develops technical and/or business solutions to complex problems.* Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.* Guides the successful completion of major programs, projects and/or functions.* Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.* Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.* Has complete understanding and wide application of technical principles, theories, concepts and techniques.* Has extensive knowledge of other related disciplines.* Applies strong analytical and business communication skills.* Ability to identify, author, maintain and train staff on key data management SOPs and work-practice guidelines.* Knowledge of Good Clinical Practices (GCP) is essential.* Demonstrated success managing data management activities performed by external vendors.* Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.* #J-18808-Ljbffr
    $197k-279k yearly est. 1d ago
  • SVP and GM of ICR/GPS

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    * 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
    $180k-263k yearly est. 4d ago
  • Senior Director, IT Product Management - SAP Platform

    Exelixis, Inc. 4.9company rating

    Alameda, CA job

    **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
    $157k-211k yearly est. 5d ago

Learn more about Myriad Genetics jobs

Most common locations at Myriad Genetics