Senior Associate Scientist jobs at Regeneron - 1233 jobs

**About This Role** Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.As the Lead, Clinical Pharmacology, Immunology, you will serve on program and study teams, providing strategic leadership in the development and execution of clinical pharmacology plans for drug candidates. You will integrate knowledge of clinical and quantitative pharmacology to optimize and provide rationale for dosage regimens Work with program and/or study teams to achieve program goals and provide deliverables in approved timeframes Maintain cutting edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology, and drug development precedent**Qualifications** 5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD) Ability to analyze and interpret PK and PK/PD data utilizing sound scientific principles Experience with designing and implementing relevant elements of clinical studies and/or dedicated Clinical Pharmacology studies Ability to develop Clinical Pharmacology strategy in the context of the broader development paradigm Knowledge of and ability to apply appropriate regulatory and ICH guidelines with regard to the acquisition, analysis, and interpretation of clinical pharmacology dataon experience with developing and implementing Quantitative Systems Pharmacology (QSP) models, and/or population PK, PKPD, exposure-response analyses Experience with Model Informed Drug Development (MIDD) paired meeting program is a plus Proficiency with use of PK/PD software packages such as Phoenix, R, NONMEM. Experience with Monolix and MATLAB is a plus Excellent oral and written communication skills for effective interactions in various environments including, but not limited to, multidisciplinary teams, regulatory agencies, scientific symposia, and advisory boards The base compensation range for this role is $144,000.00-$240,000.00. Base salary is determined by a combination of factors including, but not limited to, job-related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen's LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families *physical, financial, emotional,* and *social well-being*; including, but not limited to:* Medical, Dental, Vision, & Life insurances* Fitness & Wellness programs including a fitness reimbursement* Short- and Long-Term Disability insurance* A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)* Up to 12 company paid holidays + 3 paid days off for Personal Significance* 80 hours of sick time per calendar year* Paid Maternity and Parental Leave benefit* 401(k) program participation with company matched contributions* Employee stock purchase plan* Tuition reimbursement of up to $10,000 per calendar year* Employee Resource Groups participation We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. #J-18808-Ljbffr

Headquartered in Miami, Aldea is a next-generation AI company focused on voice-based clinical and expert applications. Our flagship product, Advisor, uses proprietary AI to scale the impact of world-class minds across personal development, finance, parenting, relationships, and more-with faster, more cost-effective performance than traditional models. As a multidisciplinary team of builders, researchers, and product thinkers, we value clear thinking, sharp writing, and strong intuition for what people need. This is a rare opportunity to join an early-stage startup that will help define a new category. About Aldea Aldea is a multi-modal foundational AI company reimagining the scaling laws of intelligence. We believe today's architectures create unnecessary bottlenecks for the evolution of software. Our mission is to build the next generation of foundational models that power a more expressive, contextual, and intelligent human-machine interface. The Role We are hiring a Foundational AI Research Scientist (LLMs) to pioneer next-generation large-language-model architectures. Your work will focus on designing, prototyping, and empirically validating efficient transformer variants and attention mechanisms that can scale to production-grade systems. You'll explore cutting‑edge ideas in efficient sequence modeling, architecture design, and distributed training-building the foundations for Aldea's next‑generation language models. This role is ideal for researchers who combine deep theoretical grounding with hands‑on systems experience. What You'll Do Research and prototype sub‑quadratic attention architectures to unlock efficient scaling of large language models. Design and evaluate efficient attention mechanisms including state‑space models (e.g., Mamba), linear attention variants, and sparse attention patterns. Lead pre‑training initiatives across a range of model scales from 1B to 100B+ parameters. Conduct rigorous experiments measuring the efficiency, performance, and scaling characteristics of novel architectures. Collaborate closely with product and engineering teams to integrate models into production systems. Stay at the forefront of foundational research and help shape Aldea's long‑term model roadmap. Minimum Qualifications Requires a Ph.D. in Computer Science, Engineering, or related field. 3+ years of relevant industry experience. Deep understanding of modern sequence modeling architectures including State Space Models (SSMs), Sparse Attention mechanisms, Mixture of Experts (MoE), and Linear Attention variants. Hands‑on experience pre‑training large language models across a range of scales (1B+ parameters). Expertise in PyTorch, Transformers, and large‑scale deep‑learning frameworks. Proven ability to design and evaluate complex research experiments. Demonstrated research impact through patents, deployed systems, or core‑model contributions. Nice to Have Experience with distributed training frameworks and multi‑node optimization. Knowledge of GPU acceleration, CUDA kernels, or Triton optimization. Publication record in top‑tier ML venues (NeurIPS, ICML, ICLR) focused on architecture research. Experience with model scaling laws and efficiency‑performance tradeoffs. Background in hybrid architectures combining attention with alternative sequence modeling approaches. Familiarity with training stability techniques for large‑scale pre‑training runs. Performance‑based bonus aligned with research and model milestones Equity participation Flexible Paid Time Off Comprehensive health, dental, and vision coverage #J-18808-Ljbffr

Headquartered in Miami, Aldea is a next-generation AI company focused on voice-based clinical and expert applications. Our flagship product, Advisor, uses proprietary AI to scale the impact of world-class minds across personal development, finance, parenting, relationships, and more-with faster, more cost-effective performance than traditional models. As a multidisciplinary team of builders, researchers, and product thinkers, we value clear thinking, sharp writing, and strong intuition for what people need. This is a rare opportunity to join an early-stage startup that will help define a new category. About Aldea Aldea is a multi-modal foundational AI company reimagining the scaling laws of intelligence. We believe today's architectures create unnecessary bottlenecks for the evolution of software. Our mission is to build the next generation of foundational models that power a more expressive, contextual, and intelligent human-machine interface. The Role We are seeking a Foundational AI Research Scientist (Speech) to advance the frontier of speech understanding and generation. You will lead applied research in speech-to-text (STT), text-to-speech (TTS), and speech-to-speech modeling, designing architectures and training strategies that redefine fidelity, controllability, and efficiency in voice-based systems. This role blends deep research expertise with strong engineering intuition. You'll drive end-to-end experimentation-from model design and training-pipeline setup to empirical validation-and help translate breakthroughs into production-grade systems. What You'll Do Research and prototype novel architectures for STT, TTS, and speech-to-speech modeling. Design and execute experiments validating new methods for scalability, performance, and quality. Collaborate cross-functionally with engineering teams to integrate research into real-world products. Stay current with foundational research in speech processing and generative modeling. Minimum Qualifications Requires a Ph.D. in Computer Science, Engineering, or related field 3+ years of relevant industry experience Demonstrated experience in training or researching TTS, STT, or speech-to-speech models. Deep understanding of modern sequence modeling architectures including State Space Models (SSMs), Sparse Attention mechanisms, Mixture of Experts (MoE), and Linear Attention variants Proven experience with pre-training foundational models from scratch on large-scale datasets. Track record of working with massive multi-modal datasets (audio, text, and speech corpora at scale). Deep expertise in PyTorch, Transformers, and modern deep-learning frameworks. Ability to translate complex research ideas into high-performance, maintainable code. Evidence of research excellence through impactful technical contributions. Nice to Have Experience with voice-based AI applications or multi-speaker synthesis. Publication record in top-tier venues (ICML, NeurIPS, ICLR, ICASSP, Interspeech). Background in cross-lingual or multilingual speech systems. Experience with data curation, filtering, and quality assessment pipelines for speech data. Performance-based bonus aligned with research milestones Equity participation Comprehensive health, dental, and vision coverage #J-18808-Ljbffr

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

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

A multi-modal foundational AI company is seeking a Foundational AI Research Scientist to lead research on large-language-model architectures. The role involves designing and validating new transformer variants and attention mechanisms for production systems. Ideal candidates will have a Ph.D. and 3+ years of industry experience in AI research, with deep knowledge of sequence modeling architectures and pre-training of large models. The position offers a competitive salary, flexible PTO, and comprehensive benefits. #J-18808-Ljbffr

A pioneering AI company based in San Francisco seeks a Foundational AI Research Scientist (Speech) to drive advancements in speech understanding and generation. This role requires a Ph.D. and extensive experience in TTS and STT systems. Responsibilities include prototyping architectures, executing validation experiments, and collaborating with engineering teams. The ideal candidate will have deep expertise in modern sequence modeling and a proven track record with large-scale datasets. A strong engineering intuition and the ability to translate complex ideas into maintainable code are essential. #J-18808-Ljbffr

A pioneering AI technology company in San Francisco seeks a Foundational AI Research Scientist (Speech) to advance speech understanding and generation. The role involves leading research in STT, TTS, and speech-to-speech modeling, requiring a Ph.D. and substantial experience in training foundational models. Candidates should possess deep expertise in modern sequence modeling architectures and a history of impactful research contributions. The company offers flexible paid time off and comprehensive health coverage. #J-18808-Ljbffr

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

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

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

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

* 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

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

An innovative AI startup in San Francisco is looking for a Foundational AI Research Scientist to pioneer next-generation large-language-model architectures. Ideal candidates will have a deep understanding of sequence modeling architectures, expertise in PyTorch, and experience in pre-training large language models. Join a dynamic team to help shape the future of intelligent human-machine interfaces. #J-18808-Ljbffr

A biotechnology company in San Diego is seeking a Senior Principal Scientist specializing in DMPK Translational PKPD Modeling. The role involves developing mechanistic PK/PD models, leading drug discovery project teams, and collaborating with diverse research disciplines. Candidates must hold a PhD in Biochemistry or related field and possess substantial industry experience in pharmacokinetics. The position offers a competitive salary range of $156,900 to $214,000 with additional benefits including bonuses, retirement plans, and comprehensive health coverage. #J-18808-Ljbffr

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

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

A global healthcare company is hiring a Senior Medical Science Liaison for Solid Tumor Oncology in the Northeast. This role involves developing territory plans, engaging with KOLs, and addressing educational needs in the field. Candidates should have a doctorate and 2+ years of MSL experience, with a preference for oncology expertise. The position offers a competitive salary range, annual performance bonus, and a comprehensive benefits package including health insurance and retirement plans. #J-18808-Ljbffr