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Research And Development Scientist jobs at Gilead Sciences - 170 jobs

  • Principal Scientist, Quality Control Lead, Small Molecules

    Gilead Sciences, Inc. 4.5company rating

    Research and development scientist job at Gilead Sciences

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life‑changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description The Principal Scientist, Quality Control (QC) Lead will be responsible for the strategic oversight and operational execution of cGMP analytical testing in support of small molecule clinical development programs. The role provides leadership for assigned programs across a range of QC activities, ensuring that testing, documentation, and data integrity standards meet regulatory requirements and project deliverables. Key Responsibilities Define, implement, and continuously improve the QC strategy for small molecule clinical development programs in alignment with overall CMC and quality objectives. Serve as the point of contact for overall QC activities including method validation and transfer, reference materials, specifications, cGMP release testing, stability strategy and testing, and supervision of testing at external contract testing laboratories. Develop and maintain phase‑appropriate QC strategies and processes to support manufacturing and regulatory submissions. Manage and approve specifications, collaborating cross‑functionally to establish scientifically sound and phase‑appropriate specifications aligned with analytical capability, process understanding, and clinical and regulatory expectations. Represent QC on cross‑functional product development teams, providing technical input and direction for analytical and quality decisions. Identify and drive opportunities for improvement in QC testing, workflows, data management, and compliance processes. Proactively identify and elevate potential QC risks, and communicate QC activities, risks, and issues to relevant stakeholders. Oversee and ensure compliant execution of QC testing for raw materials, intermediates, drug substance, and drug product. Ensure timely creation, review, and approval of QC documentation including test methods, protocols, reports, CoAs, and quality records. Provide QC oversight to contract testing laboratories, coordinating testing activities for on‑time delivery and confirming compliance with cGMP and data integrity expectations. Direct and oversee timely resolution of QC testing related investigations with comprehensive root‑cause analysis, risk assessment, and effective CAPAs. Ensure QC operations comply with cGMP, FDA, EMA, ICH, and other applicable regulations. Drive excellence in data integrity, documentation practices, and traceability across QC activities. Serve as a QC subject‑matter expert to draft and review CMC sections and supporting documents for regulatory filings and responses to questions (RTQs). Partner closely with Analytical Development, Manufacturing, Quality Assurance, Regulatory, and Supply Chain to ensure seamless coordination of analytical strategy and QC testing support throughout the product lifecycle. Support technology transfer and method implementation at internal and external laboratories. Provide QC input into product development and regulatory submission documentation. Basic Qualifications PhD or PharmD in a related field with 5+ years of experience. Master's Degree with 8+ years of experience. Bachelor's Degree with 10+ years of experience. Associate's Degree with 12+ years of experience. High School Degree with 14+ years of experience. Preferred Qualifications 10+ years of hands‑on and leadership experience in small molecule pharmaceutical analytical testing and quality control. Prior experience establishing analytical specifications and authoring CMC sections of regulatory submissions. Deep understanding of regulatory and phase‑appropriate QC expectations for clinical development. Demonstrated experience managing testing activities at external testing laboratories. Excellent scientific judgment, communication, cross‑functional collaboration, and influencing skills. Demonstrated ability to organize, plan, and execute multiple tasks with flexibility for changing priorities and plans. Must think critically and creatively and be able to work independently to determine appropriate strategy and resources for resolution of problems. Knowledge of medical devices and combination products. Salary and Benefits The salary range for this position is $195,670.00 - $253,220.00. Compensation varies by experience, qualifications, and geography. The position may also be eligible for a discretionary annual bonus, stock‑based long‑term incentives, paid time off, and a benefits package including 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 ****************************************************************** Equal Employment Opportunity 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, gender identity and expression, veteran status, and other prohibited grounds specified in applicable federal, state, and local laws. #J-18808-Ljbffr
    $195.7k-253.2k yearly 4d ago
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  • Principal Scientist, Protein Therapeutics

    Gilead Sciences, Inc. 4.5company rating

    Research and development scientist job at Gilead Sciences

    Ph.D. in biochemistry, structural biology or a related field with 6+ years (postdoctoral training preferred) **OR** M.S. with 8+ years (16+ years preferred) **OR** B.S. with 10+ years (18+ years preferred) of additional experience in an academic or industrial setting and a record of accomplishments in the form of high impact publications or patents* Extensive experience advancing protein therapeutics from discovery to development and stays abreast with emerging protein engineering platforms and technologies* Expertise in structure-based protein engineering and design of multispecifics, immunocytokines, Fc engineering, and fusion proteins* Skilled practitioner in antibody engineering, including humanization, sequence liability remediation, and/or biophysical property improvement* Project leadership experience in Research across multiple therapeutic areas, with deep understanding of hit-to-lead selection through preclinical development of therapeutic candidates* Presentation and high impact publication record with demonstrable protein engineering expertise* Proficient in various molecular biology and/or library building techniques (e.g. PCR fragment assembly, vector design, site-directed mutagenesis, Gibson assembly, and/or Golden gate cloning), as well as hands-on experience (preferred) with mammalian cell culture, protein expression, purification, and characterization; in vitro and in vivo antibody discovery approaches is a plus* Experience with computational design tools preferred (e.g. Rosetta, MOE, or DiscoveryStudio)* Team player with strong collaboration, communication, organizational skills, and excellent problem-solving skills #J-18808-Ljbffr
    $126k-178k yearly est. 2d ago
  • Senior Machine Learning Scientist, BRAID (Clinical Sciences ML)

    Genentech 4.5company rating

    San Francisco, CA jobs

    A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. Advances in AI, data, and computational sciences are transforming drug discovery and development. Roche's Research and Early Development organisations at Genentech (gRED) and Pharma (pRED) have demonstrated how these technologies accelerate R&D, leveraging data and novel computational models to drive impact. Seamless data sharing and access to models across gRED and pRED are essential to maximising these opportunities. The new Computational Sciences Center of Excellence (CoE) is a strategic, unified group whose goal is to harness the transformative power of data and Artificial Intelligence (AI) to assist our scientists in both pRED and gRED to deliver more innovative and transformative medicines for patients worldwide. The Opportunity Genentech is seeking an exceptional Senior Machine Learning Scientist to join the BRAID (Biology Research | AI Development) team within our Computational Sciences organization. This role will focus on developing novel machine learning methods to transform clinical trial design and translational medicine, with a strong emphasis on foundation models for clinical genomics and real-world data. You will work at the intersection of machine learning, omics (DNA, RNA), and EHR data, advancing algorithms that integrate biological and clinical modalities to improve patient stratification, target selection, and treatment outcomes. The ideal candidate will possess in-depth expertise in modern machine learning approaches (e.g., transformer-based models, generative modeling, representation learning) and a track record of impactful research in clinical genomics or multimodal biomedical data analysis. A passion for interdisciplinary collaboration and a commitment to open scientific communication are essential. In this role, you will Design and implement novel machine learning algorithms tailored to the complexities of clinical trial data (e.g., sequence models for patient omics data). Collaborate with cross-functional teams including biologists, clinicians, data scientists, and other stakeholders to integrate machine learning solutions into clinical decision-making. Work closely with biologists, clinicians, and translational scientists to develop clinically meaningful AI tools that integrate molecular signatures, patient trajectories, and trial outcomes. Analyze large-scale datasets including whole transcriptome, whole exome, and real-world clinical data to derive insights into disease progression, treatment response, and patient stratification. Maintain awareness of current research trends in machine learning for biomedicine and contribute to scientific leadership in this space. Publish research in top-tier ML and computational biology conferences and journals. Who you are Educational Background: Ph.D. in Computer Science, Machine Learning, Statistics, Mathematics, Physics, or a related field. Experience: Proven track record of developing and applying advanced ML models in a research or industry setting. Technical Skills: Proficiency in scientific programming languages such as Python as well as MLOps workflows (e.g., code version control, high-performance compute infrastructures, and machine learning experiment monitoring workflows). Strong experience with ML frameworks such as PyTorch, JAX, or TensorFlow. Solid foundation in probabilistic modeling, deep learning, and representation learning. Soft Skills: Excellent communication, collaboration, and problem-solving skills. Publications: Strong publication record in ML, bioinformatics, or computational biology venues (e.g., NeurIPS, ICML, ICLR, RECOMB, Bioinformatics). Preferred Prior experience developing foundation models for omics or EHR data, including pretraining or fine-tuning strategies. Deep knowledge of representation learning, generative modeling (e.g., VAEs, diffusion models, masked transformers), and multi-modal learning. Experience integrating biological priors (e.g., pathways, ontologies, knowledge graphs) into model design. Passion for advancing healthcare through innovation in ML and computational biology. This opportunity needs to be based at Genentech in South San Francisco, and relocation benefits are available. The expected salary range for this position, based on the primary location of California, is $167,400 - 310,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. #J-18808-Ljbffr
    $167.4k-310.8k yearly 2d ago
  • Principal Scientist, Group Leader, Antibody Engineering

    Genentech 4.5company rating

    San Francisco, CA jobs

    The Position: The Opportunity We are seeking an exceptional Principal Scientist (Group Leader) to join our world-class Antibody Engineering Department, where we discover and engineer life-changing antibody drugs through pioneering science and technology. The successful candidate will lead a scientific team to enhance existing platforms and develop novel technologies to expand our pipeline of antibody-based drugs across therapeutic areas. You will focus on these areas Contribute to research at the interface between technology and biology Define important therapeutic problems in collaboration with Genentech's therapeutic areas Drive innovation to solve them through antibody engineering Our new Scientist/Group Lead will help shape the future of our antibody drug capabilities and will be expected to present their research externally and publish in peer-reviewed journals. The hire will work collaboratively in a multi-disciplinary team environment to design, validate, and advance next generation biologics that address major unmet medical needs into clinical development. We are seeking highly motivated and self-driven candidates with a passion for innovation, creativity, and commitment to translational science and drug development. Who You Are PhD in a biological science, complemented by postdoctoral training or 4+ years recent equivalent antibody engineering in academia, biotechnology and/or pharma. We encourage applications from candidates with extensive prior experience as well as those coming directly from exemplary postdoc careers. The successful candidate will have demonstrated a sustained record of productivity and substantive scientific contributions as determined by consistent high-impact publications, patent inventorship, and/or external presentations. Candidates need to be team-oriented, collegial, and have strong interpersonal and communication skills. Preferred Ideal applicants will excel in protein engineering methodologies and be well-versed in biology. Experience with engineering bi- or multi-specific antibody/protein formats is preferred. Experience with structure-based protein analysis is a plus. Research experience with antibodies is preferred but is not essential. Relocation benefits are available for this job posting. The expected salary range for this position based on the primary location of California is $143,200 to $265,900. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits #LI-KC2 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company\'s policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. #J-18808-Ljbffr
    $143.2k-265.9k yearly 3d ago
  • Principal Scientist - Quality Control Lead, Small Molecules

    Gilead Sciences, Inc. 4.5company rating

    Research and development scientist job at Gilead Sciences

    Principal Scientist - Quality Control Lead, Small Molecules Job Description At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. The Principal Scientist, Quality Control (QC) Lead will be responsible for the strategic oversight and operational execution of cGMP analytical testing in support of small molecule clinical development programs. The role provides leadership for assigned programs across a range of QC activities, ensuring that testing, documentation, and data integrity standards meet regulatory requirements and project deliverables. The ideal candidate will bring deep technical expertise in analytical chemistry and cGMP operations, a strong understanding of phase-appropriate quality control strategies and requirements, and the ability to collaborate cross-functionally to enable successful delivery of clinical supply and development milestones. Quality Control Leadership & Strategy Define, implement, and continuously improve the QC strategy for small molecule clinical development programs in alignment with overall CMC and quality objectives. Serve as the point of contact for overall QC activities including method validation and transfer, reference materials, specifications, cGMP release testing, stability strategy and testing, and supervision of testing at external contract testing laboratories. Develop and maintain phase-appropriate QC strategies and processes to support manufacturing and regulatory submissions. Responsible for the management and approval of specifications, collaborating cross-functionally to establish scientifically sound and phase-appropriate specifications aligned with analytical capability, process understanding, and clinical and regulatory expectations. Represent QC on cross-functional product development teams, providing technical input and direction for analytical and quality decisions. Identify and drive opportunities for improvement in QC testing, workflows, data management, and compliance processes. Proactively identify and elevate potential QC risks, and communicate QC activities, risks, and issues to relevant stakeholders. Analytical Testing & Documentation Oversee and ensure compliant execution of QC testing for raw materials, intermediates, drug substance, and drug product. Ensure timely creation, review, and approval of QC documentation including test methods, protocols, reports, CoAs, and quality records. Provide QC oversight to contract testing laboratories, coordinating testing activities for on‑time delivery and confirming compliance with cGMP and data integrity expectations. Direct and oversee timely resolution of QC testing related investigations with comprehensive root‑cause analysis, risk assessment, and effective CAPAs. Compliance & Regulatory Affairs Ensure QC operations comply with cGMP, FDA, EMA, ICH, and other applicable regulations. Drive excellence in data integrity, documentation practices, and traceability across QC activities. Serve as a QC subject matter expert to draft and review CMC sections and supporting documents for regulatory filings and response to questions (RTQs). Cross‑Functional Collaboration Partner closely with Analytical Development, Manufacturing, Quality Assurance, Regulatory, and Supply Chain to ensure seamless coordination of analytical strategy and QC testing support throughout the product lifecycle. Support technology transfer and method implementation at internal and external laboratories. Provide QC input into product development and regulatory submission documentation. Basic Qualifications PhD or PharmD in a related field with 5+ years of experience. Master's Degree with 8+ years of experience. Bachelor's Degree with 10+ years of experience. Associate's Degree with 12+ years of experience. High School Degree with 14+ years of experience. Preferred Qualifications 10+ years of hands‑on and leadership experience in small molecule pharmaceutical analytical testing and quality control. Prior experience establishing analytical specifications and authoring CMC sections of regulatory submissions. Deep understanding of regulatory and phase‑appropriate QC expectations for clinical development. Demonstrated experience managing testing activities at external testing laboratories. Excellent scientific judgement, communication, cross‑functional collaboration, and influencing skills. Demonstrated ability to organize, plan, and execute multiple tasks with flexibility for changing priorities and plans. Must think critically and creatively and be able to work independently to determine appropriate strategy and resources for resolution of problems. Knowledge of medical devices and combination products. Gilead Core Values Integrity (Doing What's Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) The salary range for this position is: $195,670.00 - $253,220.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Equal Employment Opportunity 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 and other prohibited grounds specified in applicable federal, state and local laws. Applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. How to Apply Please apply via the Internal Career Opportunities portal in Workday. Job Details Job Requisition ID R0048430 Full Time Job Level: Associate 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
    $195.7k-253.2k yearly 5d ago
  • Principal Scientist, Quality Control Biologics (Microbiology)

    Gilead Sciences, Inc. 4.5company rating

    Research and development scientist job at Gilead Sciences

    Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Microbiology: The QC Microbiology Principal Scientist is vital role for the success of Clinical and Commercial Biologics and Small Molecule Quality Control . This individual provid e s support for strategic leadership and overs ight of daily microbiological operations . Responsibilities include managing clinical and commercial microbiological specification strategies ( for product, raw materials and critical reagents programs ) , analytical method validations, and the compendial review program. The role will contribute to monitoring QC test method execution and leading the microbiological lifecycle management of clinical/ commercial small molecules/ biologics API/ drug substances and drug products . Department : Global Quality Control - GQC-Biologics and Small Molecules Job Responsibilities : Experience with Biologics and/or Small Molecules Quality Control microbiology and extensive knowledge of industry best practices and trends. In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally. Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories. Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness. Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist. Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions. Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision. Demonstrated the ability to influence process and outcomes across functions. Willing to support future laboratory work . Qualification s : 10+ Years experience with BS OR 8+ Years with MS OR 5+ years of experience and PhD in Microbiolo gy, Chemistry, Biochemistry or related field. 2 + years of relevant experience in a GMP Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring. Deep knowledge and experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting microbiological trends in industry. Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems. Strong organizational and planning skills. Shows excellent verbal and written communication skills and collaborative interpersonal skills. Share: Job Requisition ID R0044329 Full Time/Part Time Full-Time Job Level Associate 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
    $126k-178k yearly est. 4d ago
  • Principal Scientist, Oncology Bioinformatics

    Gilead Sciences, Inc. 4.5company rating

    Research and development scientist job at Gilead Sciences

    * Extensive hands-on experience in analyzing and interpreting RNA-Seq (bulk and single cell), WES, WGS, ATAC-Seq, CITE-Seq, and TCR-Seq data is required. The experience in analyzing other omics data (e.g., spatial transcriptome, Chip-Seq, MeRIP-seq, NanoString, multiplex qPCR, HT screening data sets) is a plus.* Strong statistics knowledge, such as probability theory, univariate and multi-variable analysis, unsupervised and supervised analysis, regression analysis, survival analysis, feature selection, and power analysis. Excellent oral and written communication skills. Demonstrated capability to synthesize scientific questions into a coherent research effort and efficiently communicate scientific findings across different functional teams and present analysis results to project review teams and senior leader committees. A proactive and self-motivated scientist with a strong work ethic and scientific rigor; ability to work in a dynamic environment and manage multiple projects in parallel and adapt to changing priorities. Demonstrated track record of producing high-quality scientific results as an individual contributor and a team member.* A PhD in bioinformatics, computational biology, biostatics, cancer genomics, or a related field with 8+ years of relevant work experience in pharmaceutical/biotech inudstry.* Excellent interpersonal and communication skills that foster collaboration and teamwork.* Good understanding of cancer biology, immunology, molecular and cell biology.* Proficiency in R, Python, Perl, JAVA, or C/C++ programming languages.* Proficiency in high performance computing and cloud computing environments. Outstanding track record of scientific and technical proficiency, evidenced by high quality publications in peer-reviewed journals.* 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. #J-18808-Ljbffr
    $126k-178k yearly est. 2d ago
  • Principal Scientist, Analytical Ops

    Gilead Sciences, Inc. 4.5company rating

    Research and development scientist job at Gilead Sciences

    United States - California - Foster City Clinical Development & Clinical Operations Regular Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life‑threatening illnesses worldwide. The Principal Scientist in Biologics Analytical Development (Pivotal and Commercial) will be responsible for leading analytical development activities encompassing analytical project leadership and development of analytical methods. Additionally, they will be responsible for ensuring that product quality targets and specifications are established for the projects they lead based on robust patient‑centric considerations throughout pivotal development. Through these activities they will play an instrumental role in ensuring successful regulatory filing strategies. Responsibilities Provide leadership to a group of analytical development scientists Mentor and guide scientists in their roles Set clear expectations and prioritization of work packages Manage workload and resources effectively Develop analytical control strategies for drug substance and drug product, ensuring patient‑centric considerations are incorporated Develop robust analytical methods for drug substance and drug product appropriate for pivotal and commercial programs Design and execution of scientifically sound and regulatory compliant method bridging strategies Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ensure timely delivery and successful commercialization of the late‑stage Biologics portfolio Exhibit comprehensive knowledge of cGMP practices and requirements Act as a key member of the extended Analytical Development leadership team to shape late‑stage development strategies Demonstrate comprehensive knowledge in key analytical CMC strategic areas including CQAs, separations methods, method bridging, reference standard, comparability, and specifications Drive for the adoption of novel and state‑of‑the‑art analytical technologies and approaches Manage and mentor talent to help cultivate a world class Biologics AD organization Basic Qualifications Bachelor's Degree and Ten Years' Experience Masters' Degree and Eight Years' Experience PhD and Five Years' Experience Preferred Qualifications Ph.D. with 5+ years or M.S. with 9+ years or B.S. with a minimum of 11+ years in Analytical Chemistry or related fields of industrial experience in biologics analytical development. Extensive experience with analytical method development and control strategies of biologics products. Well versed in separation techniques (e.g. UHPLC, CE‑SDS, iCIEF, CEX) commonly used for biologics analytical development Subject matter expert in establishing comprehensive control strategies for biologics products Expertise in the development/qualification of various assays, including for purity and process related impurities Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product. Proven track record in drafting regulatory documentation at all stages, including IND, BLA, and PAS filings. Demonstrated ability of building strong collaborations with other CMC functions. Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross‑functional engagement and influence, program management. Ability to build high performing teams and to set clear and measurable goals for staff and prioritize projects and resources. 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. #J-18808-Ljbffr
    $126k-178k yearly est. 4d ago
  • Principal Scientist, QC Microbiology (Biologics)

    Gilead Sciences, Inc. 4.5company rating

    Research and development scientist job at Gilead Sciences

    A leading biopharmaceutical company in Foster City is seeking a Principal Scientist for Quality Control in Microbiology. This full-time position involves overseeing microbiological operations critical to the success of clinical and commercial products. Ideal candidates will have over 10 years of experience and a strong background in GMP principles and microbiological testing. The role demands excellent problem-solving and communication skills, contributing to ensuring compliance with industry standards. #J-18808-Ljbffr
    $126k-178k yearly est. 4d ago
  • Associate Director/Principal Scientist

    Gilead Sciences, Inc. 4.5company rating

    Research and development scientist job at Gilead Sciences

    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
  • Lead Target Discovery Scientist - In Vitro Biology

    Amgen Sa 4.8company rating

    Thousand Oaks, CA jobs

    A leading biotech company in Thousand Oaks seeks a Senior Principal Scientist to lead a team focused on in vitro modeling for target discovery. This role involves collaboration across therapeutic areas and implementing innovative technologies. Candidates should have a doctorate and extensive experience in a related field. Competitive compensation, flexible work models, and a comprehensive benefits package are offered. #J-18808-Ljbffr
    $125k-173k yearly est. 4d ago
  • Technical Development Scientist 3

    Genentech 4.5company rating

    South San Francisco, CA jobs

    ** A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Genentech, a member of the Roche Group! This position is part of Genentech's Individualized Medicines Team in Pharma Cell and Gene Therapy Group (PTC) responsible for the process development, manufacture and supply of personalized immunotherapies in collaboration with our global partners. **The Opportunity** We are seeking an exceptional, highly motivated, and technically talented individual to join the Product Attribute Sciences (PAS) team within Analytical Development & Quality Control (ADQC) of the Cell and Gene Therapy unit. PAS is responsible for developing and implementing characterization methods to enable in-depth product understanding and inform the design and refinement of the control system, including QTPP & CQAs, for all cell therapy programs. This is a lab-based role contributing to developing characterization methods (e.g. flow cytometry, ELISA, RT-qPCR/dd PCR, and cell-based potency assays), design and execution of experiments to understand mechanism-of-action (MoA), and generate data to inform decisions to support cell therapy drug development. The ideal candidate will have a background in cell biology, immunology, stem cell biology or related field and will be able to provide scientific and technical judgment as part of a team responsible for delivering high quality cell therapy products to patients. Integrity, accountability, and strong dedication to the patients we serve are critical to this role. **Keywords** Cell therapy, immunology, cell biology, stem cell biology, chimeric antigen receptors (CAR), RT-qPCR, dd PCR, flow cytometry, cell-based assays/bioassay, potency assays, immunofluorescence, method development **Responsibilities** + Develop, implement, and execute testing for assays with a wide range of readouts, including flow cytometry, ELISA, dd PCR/RT-qPCR, cell-based assays/bioassays, etc. + Independently or with minimal supervision design and execute experiments focused on identifying drivers of MoA for cell therapy drug products. + Generate high-quality data to enable data-driven decision making in support of cell therapy drug development. + Characterize cell therapy drug products by cell surface marker expression, molecular biology techniques & cell-based assays/bioassays. + Ability to work with primary cell culture. + Support data analysis/management and maintain accurate records of research using electronic lab notebook (ELN) platform. + Write development/technical reports, SOPs and test procedures. **Who You Are** **Qualifications** + Individuals with excellent experimental skills and proven scientific accomplishments. The level of the position will depend on research experience and education. + B.S./M.S. degree in the Biological Sciences such as immunology, cell biology, stem cell biology or a related discipline. + 6+ years of relevant lab-based experience in industry or academia with a focus on CMC/technical development of cell and gene therapy products. + Strong familiarity with ICH Guidelines with related Method Development experience is preferred. + High level of proficiencies in flow cytometry and cell-based assays/bioassays are required. + Extensive experience in working with primary cells is required. + Proficient in statistical analysis and data visualization to support decision-making + Strong scientific and technical thinking with the desire to learn and troubleshoot challenges. + Highly collaborative mindset with strong communication skills (both verbal and written), and the ability to effectively present data, write reports and document test procedures. + High ethical integrity and scientific rigor. Relocation benefits are available for this job posting. The expected salary range for this position based on the primary location of South San Francisco, CA is $113,900 - 211,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits (**************************************************** Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
    $113.9k-211.5k yearly 6d ago
  • Scientist 3, Discovery Oncology

    Genentech 4.5company rating

    South San Francisco, CA jobs

    ** **The Opportunity** The Department of Discovery Oncology at Genentech is excited to announce an opportunity for a lab-based Scientist with a strong interdisciplinary background. This position will be part of the RAS-MAPK Signaling and Intervention Strategies Laboratory, which focuses on understanding oncogenic signaling mechanisms and developing novel therapeutic strategies targeting the Ras/MAPK pathway. The ideal candidate will have deep expertise in cell biology and oncogenic signaling pathways. This position will focus on discovering new targets and mechanisms of action in oncogenic signaling. The successful candidate will integrate molecular biology, cell biology, and protein biochemistry to investigate differences in signaling mechanisms in normal and cancer cells. Working closely with drug discovery project teams, translational medicine, and clinical development teams, you will help identify new therapeutic hypotheses and advance discovery and development of transformative medicines. Key responsibilities include: + Interdisciplinary Collaboration: Work closely with internal experts across computational, research biology, and drug discovery disciplines to develop hypotheses and model systems that drive innovative therapeutic strategies. This will primarily be a wet-lab-based position. + Supporting drug discovery projects: Perform cell biology and biochemistry experiments to characterize drug-like molecules and investigate their mechanisms of action. + Translational Impact: Generate high-quality, original research that advances our understanding of cancer biology as well as contributing to the development of new therapies for oncologic indications. **Who You Are** + Educational Background: Ph.D. in Biochemistry, Cell Biology, or a closely related field. Postdoctoral experience is preferred, but not essential. + Experience: Your record should reflect sustained high-impact publications and/or patents, and substantial progress on projects that have deepened our understanding of cancer biology. + Technical Expertise: Demonstrated expertise in cell biology techniques including transfection and stable cell line generation, organoid culture, CRISPR/Cas9 gene editing and screening; Demonstrated expertise in molecular biology techniques including IP, qPCR, western blots, FACS, IHC, RNAseq, ChIP-seq and analysis; cancer research, and biochemistry. **Preferred** + Experience in the RAS-MAPK signaling pathway and induced proximity is a plus. + Experience with or interest in leveraging AI/ML to accelerate research is a plus. A fearless scientist who tackles difficult problems, continuously develops new skills, and applies any technique or method necessary to advance our understanding of human cancers and discover new intervention strategies. If you are excited about working in a fast-paced, science-focused, and multi-disciplinary environment to uncover novel therapeutic targets for cancer and drive transformative medicines, we encourage you to apply. This role offers a unique opportunity to make a significant impact at the forefront of research and drug discovery at Genentech. Relocation benefits are available for this posting. The expected salary range for this position based on the primary location of California is $103,400 - $192,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. **Benefits (****************************************************** Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
    $103.4k-192k yearly 27d ago
  • Scientist 3, Discovery Oncology

    Genentech 4.5company rating

    South San Francisco, CA jobs

    The Opportunity The Department of Discovery Oncology at Genentech is excited to announce an opportunity for a lab-based Scientist with a strong interdisciplinary background. This position will be part of the RAS-MAPK Signaling and Intervention Strategies Laboratory, which focuses on understanding oncogenic signaling mechanisms and developing novel therapeutic strategies targeting the Ras/MAPK pathway. The ideal candidate will have deep expertise in cell biology and oncogenic signaling pathways. This position will focus on discovering new targets and mechanisms of action in oncogenic signaling. The successful candidate will integrate molecular biology, cell biology, and protein biochemistry to investigate differences in signaling mechanisms in normal and cancer cells. Working closely with drug discovery project teams, translational medicine, and clinical development teams, you will help identify new therapeutic hypotheses and advance discovery and development of transformative medicines. Key responsibilities include: * Interdisciplinary Collaboration: Work closely with internal experts across computational, research biology, and drug discovery disciplines to develop hypotheses and model systems that drive innovative therapeutic strategies. This will primarily be a wet-lab-based position. * Supporting drug discovery projects: Perform cell biology and biochemistry experiments to characterize drug-like molecules and investigate their mechanisms of action. * Translational Impact: Generate high-quality, original research that advances our understanding of cancer biology as well as contributing to the development of new therapies for oncologic indications. Who You Are * Educational Background: Ph.D. in Biochemistry, Cell Biology, or a closely related field. Postdoctoral experience is preferred, but not essential. * Experience: Your record should reflect sustained high-impact publications and/or patents, and substantial progress on projects that have deepened our understanding of cancer biology. * Technical Expertise: Demonstrated expertise in cell biology techniques including transfection and stable cell line generation, organoid culture, CRISPR/Cas9 gene editing and screening; Demonstrated expertise in molecular biology techniques including IP, qPCR, western blots, FACS, IHC, RNAseq, ChIP-seq and analysis; cancer research, and biochemistry. Preferred * Experience in the RAS-MAPK signaling pathway and induced proximity is a plus. * Experience with or interest in leveraging AI/ML to accelerate research is a plus. A fearless scientist who tackles difficult problems, continuously develops new skills, and applies any technique or method necessary to advance our understanding of human cancers and discover new intervention strategies. If you are excited about working in a fast-paced, science-focused, and multi-disciplinary environment to uncover novel therapeutic targets for cancer and drive transformative medicines, we encourage you to apply. This role offers a unique opportunity to make a significant impact at the forefront of research and drug discovery at Genentech. Relocation benefits are available for this posting. The expected salary range for this position based on the primary location of California is $103,400 - $192,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $103.4k-192k yearly 27d ago
  • Scientist 3, Discovery Oncology

    Genentech 4.5company rating

    South San Francisco, CA jobs

    The Opportunity The Department of Discovery Oncology at Genentech is excited to announce an opportunity for a lab-based Scientist with a strong interdisciplinary background. This position will be part of the RAS-MAPK Signaling and Intervention Strategies Laboratory, which focuses on understanding oncogenic signaling mechanisms and developing novel therapeutic strategies targeting the Ras/MAPK pathway. The ideal candidate will have deep expertise in cell biology and oncogenic signaling pathways. This position will focus on discovering new targets and mechanisms of action in oncogenic signaling. The successful candidate will integrate molecular biology, cell biology, and protein biochemistry to investigate differences in signaling mechanisms in normal and cancer cells. Working closely with drug discovery project teams, translational medicine, and clinical development teams, you will help identify new therapeutic hypotheses and advance discovery and development of transformative medicines. Key responsibilities include: Interdisciplinary Collaboration: Work closely with internal experts across computational, research biology, and drug discovery disciplines to develop hypotheses and model systems that drive innovative therapeutic strategies. This will primarily be a wet-lab-based position. Supporting drug discovery projects: Perform cell biology and biochemistry experiments to characterize drug-like molecules and investigate their mechanisms of action. Translational Impact: Generate high-quality, original research that advances our understanding of cancer biology as well as contributing to the development of new therapies for oncologic indications. Who You Are Educational Background: Ph.D. in Biochemistry, Cell Biology, or a closely related field. Postdoctoral experience is preferred, but not essential. Experience: Your record should reflect sustained high-impact publications and/or patents, and substantial progress on projects that have deepened our understanding of cancer biology. Technical Expertise: Demonstrated expertise in cell biology techniques including transfection and stable cell line generation, organoid culture, CRISPR/Cas9 gene editing and screening; Demonstrated expertise in molecular biology techniques including IP, qPCR, western blots, FACS, IHC, RNAseq, ChIP-seq and analysis; cancer research, and biochemistry. Preferred Experience in the RAS-MAPK signaling pathway and induced proximity is a plus. Experience with or interest in leveraging AI/ML to accelerate research is a plus. A fearless scientist who tackles difficult problems, continuously develops new skills, and applies any technique or method necessary to advance our understanding of human cancers and discover new intervention strategies. If you are excited about working in a fast-paced, science-focused, and multi-disciplinary environment to uncover novel therapeutic targets for cancer and drive transformative medicines, we encourage you to apply. This role offers a unique opportunity to make a significant impact at the forefront of research and drug discovery at Genentech. Relocation benefits are available for this posting. The expected salary range for this position based on the primary location of California is $103,400 - $192,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $103.4k-192k yearly Auto-Apply 26d ago
  • Distinguished Scientist, Discovery Chemistry

    Genentech 4.5company rating

    South San Francisco, CA jobs

    ** A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Genentech, a member of the Roche Group. **The Opportunity** We have an exciting opportunity for an experienced scientific leader and medicinal chemist to join our Small Molecule Drug Discovery Chemistry Department at Genentech in South San Francisco, CA. The successful candidate will be responsible for leading drug discovery project teams through various stages of therapeutic target identification, druggability, preferred mode-of-action assessment, hit-finding enablement, hit-to-lead, and lead optimization in a multi-disciplinary, team-based culture. They will have particularly deep expertise in the early stages of drug discovery projects and would be working closely with therapeutic area leaders to evaluate potential targets. The position will entail responsibilities for influencing drug discovery practices and interacting directly with various functions such as Biochemical and Cellular Pharmacology, Drug Metabolism and Pharmacokinetics, Pharmaceutical Sciences, Safety Sciences, and Structural Biology. **Who You Are** + You will have a Ph.D. with 15+ years of medicinal chemistry experience in industry in the design and synthesis of analogs for molecular targets by applying state-of-the-art structure-driven and property-based design principles with deep experience in establishing and implementing successful partnerships with contract research organizations (CROs). + You will demonstrate a strong record of accomplishments as noted by significant and creative contributions to the success of small-molecule projects. + Lead, mentor, and provide career development for department staff and influence medicinal chemistry teams. + You will convey strong verbal and written communication skills and an ability to work collaboratively in teams. **Preferred** + Particular enthusiasm for mentoring colleagues across a wide range of experiences and disciplines is desired. The expected salary range for the Distinguished Scientist position based on the primary location of South San Francisco, CA is $196,100 - $364,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits (**************************************************** Relocation benefits are approved for this posting. \#LI-KC2 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
    $125k-166k yearly est. 60d+ ago
  • Distinguished Scientist, Discovery Chemistry

    Genentech 4.5company rating

    South San Francisco, CA jobs

    A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Genentech, a member of the Roche Group. The Opportunity We have an exciting opportunity for an experienced scientific leader and medicinal chemist to join our Small Molecule Drug Discovery Chemistry Department at Genentech in South San Francisco, CA. The successful candidate will be responsible for leading drug discovery project teams through various stages of therapeutic target identification, druggability, preferred mode-of-action assessment, hit-finding enablement, hit-to-lead, and lead optimization in a multi-disciplinary, team-based culture. They will have particularly deep expertise in the early stages of drug discovery projects and would be working closely with therapeutic area leaders to evaluate potential targets. The position will entail responsibilities for influencing drug discovery practices and interacting directly with various functions such as Biochemical and Cellular Pharmacology, Drug Metabolism and Pharmacokinetics, Pharmaceutical Sciences, Safety Sciences, and Structural Biology. Who You Are * You will have a Ph.D. with 15+ years of medicinal chemistry experience in industry in the design and synthesis of analogs for molecular targets by applying state-of-the-art structure-driven and property-based design principles with deep experience in establishing and implementing successful partnerships with contract research organizations (CROs). * You will demonstrate a strong record of accomplishments as noted by significant and creative contributions to the success of small-molecule projects. * Lead, mentor, and provide career development for department staff and influence medicinal chemistry teams. * You will convey strong verbal and written communication skills and an ability to work collaboratively in teams. Preferred * Particular enthusiasm for mentoring colleagues across a wide range of experiences and disciplines is desired. The expected salary range for the Distinguished Scientist position based on the primary location of South San Francisco, CA is $196,100 - $364,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Relocation benefits are approved for this posting. #LI-KC2 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $125k-166k yearly est. 60d+ ago
  • Distinguished Scientist, Discovery Chemistry

    Genentech 4.5company rating

    South San Francisco, CA jobs

    A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Genentech, a member of the Roche Group. The Opportunity We have an exciting opportunity for an experienced scientific leader and medicinal chemist to join our Small Molecule Drug Discovery Chemistry Department at Genentech in South San Francisco, CA. The successful candidate will be responsible for leading drug discovery project teams through various stages of therapeutic target identification, druggability, preferred mode-of-action assessment, hit-finding enablement, hit-to-lead, and lead optimization in a multi-disciplinary, team-based culture. They will have particularly deep expertise in the early stages of drug discovery projects and would be working closely with therapeutic area leaders to evaluate potential targets. The position will entail responsibilities for influencing drug discovery practices and interacting directly with various functions such as Biochemical and Cellular Pharmacology, Drug Metabolism and Pharmacokinetics, Pharmaceutical Sciences, Safety Sciences, and Structural Biology. Who You Are You will have a Ph.D. with 15+ years of medicinal chemistry experience in industry in the design and synthesis of analogs for molecular targets by applying state-of-the-art structure-driven and property-based design principles with deep experience in establishing and implementing successful partnerships with contract research organizations (CROs). You will demonstrate a strong record of accomplishments as noted by significant and creative contributions to the success of small-molecule projects. Lead, mentor, and provide career development for department staff and influence medicinal chemistry teams. You will convey strong verbal and written communication skills and an ability to work collaboratively in teams. Preferred Particular enthusiasm for mentoring colleagues across a wide range of experiences and disciplines is desired. The expected salary range for the Distinguished Scientist position based on the primary location of South San Francisco, CA is $196,100 - $364,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Relocation benefits are approved for this posting. #LI-KC2 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $125k-166k yearly est. Auto-Apply 60d+ ago
  • Process Development Associate - Large Molecule Release Testing

    Amgen 4.8company rating

    Thousand Oaks, CA jobs

    **Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Process Development Associate - Large Molecule Release Testing** **What you will do** Let's do this! Let's change the world! Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization is responsible for defining the critical quality attributes of Amgen's therapies and advancing innovative analytical tools to support their development. Within AS, the Large Molecule Release Testing (LMRT) team in the Pre-Pivotal Biologics Attribute Sciences function supports release and stability testing of toxicology and clinical batches in a phase-appropriate GMP environment. The LMRT team collaborates closely with cross-functional partners to support analytical method co-development, co-qualification, and method transfer activities. **Key responsibilities for the PD Associate role include:** + Cell culture maintenance, reagents/media/buffer preparation, and relevant support. + Routine laboratory maintenance such as restocking, ordering, and assistance in safety actions and audit readiness. + Performing cell-based assays, binding assays, ELISA and qPCR assays etc. + Generating robust and reliable data, organizing and reporting data in a validated system under minimal direction. + Supporting method hand-off and troubleshooting. + Maintaining and updating monthly Work Order (WO) tracking for PM and calibration activities using Maximo. + Managing critical reagent extensions by reviewing monthly needs, submitting requests with supporting assay data, and updating COA. + Managing reagents freezer inventory through detailed manual counts and maintenance of inventory tracking records. + Coordinating monthly pipette calibration, including collection, verification of WO closure, and initiation of HLEE investigations for out-of-tolerance results. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The lab-based professional we seek is a scientist with the following qualifications. **Basic Qualifications:** + High school diploma / GED and 4 years of Scientific experience OR + Associate's degree and 2 years of Scientific experience OR + Bachelor's degree **Preferred Qualifications:** + B.S. or M.S. Degree in Cell Biology, Molecular Biology, Biomedical Engineering, Biochemistry or related technical subject area + Demonstrated ability in the biotech industry, including but not limited to GxP regulations. + Experience in cell culture, cell-based bioassay, immunoassays, and qPCR etc. + Experience developing, qualifying, and testing analytical methods. + Excellent documentation skills, including an understanding of GxP requirements. + Excellent communication (oral and written) skills and attention to detail. **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: + A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans + Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. **Sponsorship** Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
    $72k-87k yearly est. 5d ago
  • Process Development Associate - Large Molecule Release Testing

    Amgen 4.8company rating

    Thousand Oaks, CA jobs

    Career CategoryScientificJob Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Process Development Associate - Large Molecule Release Testing What you will do Let's do this! Let's change the world! Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization is responsible for defining the critical quality attributes of Amgen's therapies and advancing innovative analytical tools to support their development. Within AS, the Large Molecule Release Testing (LMRT) team in the Pre-Pivotal Biologics Attribute Sciences function supports release and stability testing of toxicology and clinical batches in a phase-appropriate GMP environment. The LMRT team collaborates closely with cross-functional partners to support analytical method co-development, co-qualification, and method transfer activities. Key responsibilities for the PD Associate role include: Cell culture maintenance, reagents/media/buffer preparation, and relevant support. Routine laboratory maintenance such as restocking, ordering, and assistance in safety actions and audit readiness. Performing cell-based assays, binding assays, ELISA and qPCR assays etc. Generating robust and reliable data, organizing and reporting data in a validated system under minimal direction. Supporting method hand-off and troubleshooting. Maintaining and updating monthly Work Order (WO) tracking for PM and calibration activities using Maximo. Managing critical reagent extensions by reviewing monthly needs, submitting requests with supporting assay data, and updating COA. Managing reagents freezer inventory through detailed manual counts and maintenance of inventory tracking records. Coordinating monthly pipette calibration, including collection, verification of WO closure, and initiation of HLEE investigations for out-of-tolerance results. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The lab-based professional we seek is a scientist with the following qualifications. Basic Qualifications: High school diploma / GED and 4 years of Scientific experience OR Associate's degree and 2 years of Scientific experience OR Bachelor's degree Preferred Qualifications: B.S. or M.S. Degree in Cell Biology, Molecular Biology, Biomedical Engineering, Biochemistry or related technical subject area Demonstrated ability in the biotech industry, including but not limited to GxP regulations. Experience in cell culture, cell-based bioassay, immunoassays, and qPCR etc. Experience developing, qualifying, and testing analytical methods. Excellent documentation skills, including an understanding of GxP requirements. Excellent communication (oral and written) skills and attention to detail. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 82,898.00 USD - 92,522.00 USD
    $72k-87k yearly est. Auto-Apply 8d ago

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