Principal Research Scientist jobs at Johnson & Johnson - 1342 jobs

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Discovery & Pre-Clinical/Clinical Development **Job Sub** **Function:** Multi-Family Pre-Clinical Development - Medtech **Job Category:** People Leader **All Job Posting Locations:** Cincinnati, Ohio, United States of America **Job Description:** We are searching for the best talent for a Principal Scientist, Nonclinical Surgery located in Cincinnati, OH. Purpose: Functioning as a primary surgeon, with a primary focus on cardiovascular procedures, to provide surgical expertise and technical leadership during research, development, and evaluation of surgical devices using animate, inanimate, and cadaveric models. Performing surgical research & testing which support development of products or procedures in standard and minimally invasive surgery (open, laparoscopic, and robotic). Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will: + Conducting and / or directing surgical investigations for product development and preclinical evidence generation. + Use scientific and surgical expertise to evaluate functionality, efficacy, and safety of medical devices during acquisition, licensure, discovery, development, and product change evaluations. + Provide biomedical expertise by making unbiased recommendations to ETHICON teams regarding new technologies and interaction of device concepts on living tissue. + Provide technical direction and execution within Preclinical Research for surgical investigation and development of medical devices. + Collaborating with Preclinical Research team to apply clinically relevant models for product evaluation, while meeting preclinical study design, execution, and timeline requirements. + Support the Preclinical Research team with the development of animal models. + Responsible for communicating business related issues or opportunities to next management level + For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable + Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures + Know & follow ETHICON policies & procedures related to work activities performed in area of responsibility. + Utilize interpersonal skills and collaboration to enhance team processes and drive surgical efficiency/quality within Preclinical Research, ETHICON, and J&J. + Function as key Preclinical Research team member by energetically supporting the goals of the department, ETHICON, and J&J by actively participating in and collaborating with the external scientific community. + Performs other duties assigned as needed Education: + A minimum of a Doctorate degree is highly preferred (DVM/VMD from an (AVMA) American Veterinary Medical Association accredited program; MD is also acceptable with significant preclinical experience) + Surgical residency training and board certification (DACVS) is preferred. + Certification as a Surgical Research Specialist (SRS) through the Academy of Surgical Research may also be considered based on experience level. + Demonstrated knowledge of surgical principles and theory is required, with specific training in cardiovascular procedures also required. + Demonstrated knowledge and experience in performing fluoroscopic angiography in large animals is required + Experience in executing preclinical and/or clinical studies, including GLP, with external contract research organizations is preferred. + Ability to work collaboratively with the preclinical research team is required. + Familiarity with Medical Device Product Development is preferred. + Knowledge of preclinical regulatory requirements for FDA and notified bodies outside the US is preferred. Required Skills & Experience: + Extensive knowledge of cardiovascular surgery as well as interventional procedures. + Deep knowledge of animal and human anatomy and physiology, as well as biological systems. + Demonstrated analytical problem-solving and decision-making skills. + Demonstrated surgical expertise during research, development, & evaluation by utilizing animate, inanimate and cadaveric models. + Ability to work as a technical leader, team member, and role model for preclinical staff. + Excellent communication skills - written/oral/listening. + Working with minimal supervision. + Ability to clearly document and communicate plans and results. + Possess the motivation and work ethic to successfully complete studies/surgical procedures on time and with high quality. + Able to manage multiple tasks and responsibilities. + Serve as a preclinical subject matter expert on technical/surgical evaluation concerning device performance. + Able to bring new scientific principles / innovative technical solutions to projects / studies. + Robust surgical technique & mastery of open and laparoscopic procedures spanning multiple animal models. Robotic surgical experience is desired, but not required. + Knowledge of regulations regarding medical device development and the utilization of live animals in preclinical research. Other: + This position is based in Cincinnati, OH, and requires up to 25% travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource.

A biopharmaceutical company in San Diego seeks a Principal Scientist to lead an in vitro pharmacology team. Candidates should have a Ph.D. and over 8 years in drug discovery, particularly with GPCRs. Responsibilities include designing assays, managing a team, and collaborating on research projects. The competitive salary ranges from $158,000 to $197,000, with comprehensive benefits including health insurance and PTO. #J-18808-Ljbffr

The role will be responsible for all operations involved with routine manufacturing and quality control testing of radiopharmaceuticals produced in Aktis' GMP laboratory (Boston, MA), including but not limited to the list below. This role will report to the Director of Clinical Trial Manufacturing. Salary Range: $136,800.00 To $189,200.00 Annually Responsibilities Manual and automated production of radiopharmaceuticals in a GMP facility QC testing of radiopharmaceuticals Execution and upkeep of the facilities' environmental monitoring program Accurate and timely preparation and completion of manufacturing and Quality control records (Batch Records, Forms, Logbooks, etc.) Process/analytical method validation for clinical manufacturing Operation and maintenance of equipment in the GMP facility Preparation of products for shipment to other sites Drafting, reviewing and updating GMP documentation including SOPs Upkeep and maintenance of inventory in the GMP Facility Maintenance of the GMP facility including assisting with radioactive waste stream management Perform contamination wipe tests and surveys Performing and maintenance of the facilities' environmental monitoring program Leading manufacturing process and analytical method qualification activities Contribute to writing CMC sections for submission to regulatory agencies Maintain KPI and internal reports Supporting external tech transfer activities Required Skills Proficient with aseptic operations and environmental monitoring Proficient with QC methodologies (HPLC, GC, MS, Gamma Spec, etc.) Proficient with assembly and interpretation of analytical data Expertise with troubleshooting analytical and production equipment High attention to detail and organizational skills to enable working in a fast-paced environment Ability to work in an ISO7 environment with full gowning Adhere to stringent cleanroom protocols and maintain a high level of hygiene Perform precise aseptic manipulations in a restrictive environment Awareness of FDA and EU GMP requirements Ability to lift 60lbs Expertise with GMP radiopharmaceutical manufacturing and quality control Minimum, B.Sc. with 10+ years or M.Sc. with 7+ years of experience in the pharma industry or equivalent research experience Comprehensive knowledge of GMP manufacturing and quality control workflows Excellent verbal, written, and organizational skills Strong desire to be part of a mission‐oriented company leading transformative change for patients Proven demonstration of transparent communication and fostering open and diverse debate Ability to work with agility and manage ambiguity Personifies positive energy and exemplifies respect #J-18808-Ljbffr

Principal Scientist, Innovation Management, Fremont CADescription As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Principal Scientist, Innovation Management will act as a primary expert for upstream/drug substance development and manufacturing with a unique blend of expertise in biopharmaceutical upstream processes, digitalization, and data science. This role will identify and evaluate emerging technologies and companies that can enhance biopharmaceutical manufacturing. The incumbent will provide scientific and technical leadership to the team on both internal and external projects. Duties & Responsibilities Ensures direct report (intern & co-ops) safety, training, and supervision. Responsible for effective management of a team of technical experts. This is an individual contributor Role. Upstream/Drug Substance Development and Manufacturing: Leads the development and optimization of upstream processes for biopharmaceutical production. Oversees cell culture operations, including media development, bioreactor design, and scale-up processes. Ensures compliance with regulatory standards and quality control measures. Collaborates with cross-functional teams to integrate upstream processes with downstream and analytical development. Digitalization and Data Science: Implements digital tools and data analytics to enhance process understanding and control. Develops and applies predictive models for process optimization and troubleshooting. Utilizes machine learning and AI to drive continuous improvement in manufacturing processes. Manages data integrity and ensures robust data management practices. Scouting Technologies and Companies: Identifies and evaluates emerging technologies and companies that can enhance biopharmaceutical manufacturing. Conducts due diligence and feasibility assessments for potential technology acquisitions or partnerships. Collaborates with global teams to integrate new technologies into existing processes. Stays abreast of industry trends and advancements to maintain a competitive edge. Leadership and Team Collaboration: Provides scientific and technical leadership to the upstream development team. Mentors and develops team members, fostering a collaborative and high-performance culture. Manages project timelines, budgets, and resources effectively. Represents the company at industry conferences and scientific meetings. Requirements BS with ten-plus (10+) years' experience in Chemical/Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field. OR MS with six-plus (6+) years' experience in Chemical/Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field. OR PhD with three-plus (3+) years' experience in Chemical/Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field. Thorough knowledge of biotechnology process development methodologies such as cell culture, aseptic techniques, bioreactor operation and development, column chromatography, filtration, and UFDF. Knowledge of GMP biopharmaceutical manufacturing, including process validation and commercial manufacturing support. Four-plus (4+) years' experience in late-stage process development preferred. Two-plus (2+) years' experience leading in a matrixed environment preferred. Two-plus (2+) years' experience in data science, Machine learning, and statistical analysis skills Excellent verbal and written communication skills. Good documentation and presentation skills. Proven skills building and maintaining productive relationships with organizational partners such as Manufacturing and Quality. Ability to troubleshoot and challenge status quo processes and influence in a team environment. Ability to communicate complex results (e.g. hybrid models) to both internal and external stakeholders. Eligibility Requirements Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Compensation Data This position offers a base salary typically between ($115,000) and ($181,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. Please reach out Talent Acquisition or your HR Business Partner for more information. #J-18808-Ljbffr

A global biopharmaceutical company is looking for a Principal Scientist in Innovation Management. The role involves the development of upstream processes, oversight of biopharmaceutical production, and integration of digital tools in manufacturing. Candidates must have significant experience in biopharmaceutical manufacturing and possess strong leadership capabilities. This exciting opportunity advocates for collaboration, innovation, and a commitment to high-quality standards in a dynamic working environment. #J-18808-Ljbffr

A leading global healthcare firm in San Diego is seeking a highly motivated scientist to contribute to biotherapeutics development. The successful candidate will discover and engineer antibodies, oversee experiments, and utilize various molecular biology techniques. Applicants should have at least 6 years of relevant experience and a strong background in flow cytometry. This position offers competitive compensation ranging from $110,250 to $187,000 along with comprehensive benefits. #J-18808-Ljbffr

A global healthcare leader in San Diego seeks a highly motivated scientist to contribute to the discovery and development of biotherapeutics. The role involves discovering and optimizing antibodies, utilizing flow cytometry, and requires strong skills in molecular biology and biochemistry. Ideal candidates should have significant industry experience and be detail-oriented, with excellent communication skills. Competitive compensation and benefits include a flexible benefits package and bonus potential. #J-18808-Ljbffr

Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment. About the role This role encompasses leading a descriptive sensory panel and maintaining an end-use market as a sensory lead. The position requires strong leadership, technical expertise in sensory science, and the ability to collaborate cross-functionally to support business objectives through high-quality sensory insights. Key responsibilities • Lead and manage a trained sensory panel of 8-16 individuals using the Spectrum Descriptive Analysis (SDA) method. • Develop and implement project-specific training and calibration plans. • Facilitate training, calibration, and testing sessions in compliance with SDA methodology. • Define and maintain reference materials for all attributes of interest. • Monitor and evaluate panel performance; address underperformance through retraining and recalibration. • Maintain panel size through recruitment, screening, and fit-for-purpose assessments. Sensory Testing & Methodology • Design and execute sensory testing using SDA, temporal, and discrimination methods. • Analyze data using relevant sensory software and interpret panel performance metrics. • Communicate findings to sensory leads and project stakeholders. Project Collaboration & Execution • Meet with stakeholders to understand business objectives and define sensory goals. • Collaborate with sensory project leads to select appropriate methodologies and testing logistics. • Coordinate with technicians and technologists to ensure timely preparation of test materials and references. Strategic Sensory Leadership • Act as the sensory lead for an end-use market, maintaining a pipeline of internal and customer-facing projects. • Design, organize, and execute sensory studies aligned with business objectives. • Analyze and interpret test results, providing actionable insights and next steps. • Stay current with sensory science developments and adopt new techniques to enhance capabilities. Qualifications and skills Skills & Competencies: • Expertise in sensory science, particularly descriptive analysis and SDA methodology. • Strong leadership and team management skills. • Proficiency in sensory data analysis tools and statistical interpretation. • Excellent communication skills for both technical and non-technical audiences. • Ability to collaborate across functions including R&D, marketing, and business development. Experience & Qualifications: • Bachelor's, Master's, or PhD in Food Science, Sensory Science, or a related field. • Prior experience leading and managing sensory panels is essential. • Experience with Spectrum Descriptive Analysis is highly preferred. • Familiarity with temporal and discrimination testing methods. • Occasional travel (approximately once a month) may be required for customer visits or panel-related activities. The typical hiring range for this role is $75,602 to $123,432 annually and is based on several factors including but not limited to education, work experience, certifications, location, etc. In addition to your pay, Kerry offers benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and retirement contribution (all benefits and incentives are subject to eligibility requirements). Kerry is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law. Kerry will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen. Additional information can be found at: Know Your Rights: Workplace Discrimination is Illegal (dol.gov).

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

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 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 of 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. Additional Key ResponsibilitiesLeadership Mentor a lab‑based scientific team, advancing their projects and careers. Serve as a scientific and technical thought leader throughout the Research organization. Collaborate across functions to guide interdisciplinary projects, with experts in oncology, immune‑oncology, protein engineering, chemistry, translational medicine, biomarkers and clinical development. Identify project risks and mitigate effectively, while communicating with project teams and other leaders. Innovation and Scientific Acumen Proactively ideate to accelerate early‑stage discovery activities, enhance understanding of disease mechanisms, and develop new technologies and novel targeting modalities. Develop expertise in relevant scientific fields and the external landscape, including the scientific literature, conference proceedings and competitive programs. As an in‑house expert, propose creative and rigorous research to discover, validate and understand targets. Think critically and creatively, emphasizing nimble decision making that balances risk‑taking with thoughtful experimentation within the strategic/competitive context to fuel a differentiated pre‑clinical pipeline. Contribute expertise to multidisciplinary due diligence teams to evaluate and recommend partnerships and acquisitions. Contribute to research reports, INDs and patent filings. Establish an external presence through peer‑reviewed publications, conference presentations and external collaborations. Knowledge, Experience and Skills Ph.D. degree and 5+ years of experience in tumor biology, drug discovery, target identification and technology development, with post‑doctoral training highly preferred. Strong track record of impact in scientific field, including first‑ or senior‑author publications in peer‑reviewed journals and conference presentations. Strong knowledge base in cancer genomics and oncogenic signaling. Broad technical skillset of cutting‑edge methods and models of cancer, in vitro and in vivo, with experience in biochemically analyzing protein (and protein‑nucleic acid) complexes a plus. Demonstrated success in leading research teams to productive, creative, data‑driven decisions. Team‑centric mindset, with proven managerial excellence and ability to motivate skilled team members from diverse backgrounds. Excellent communication and interpersonal skills. 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. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives, 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, gender identity or expression, veteran status, disability or other protected characteristics. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. Gilead Sciences will not discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Employees who have access to the compensation information of others as part of essential job functions cannot disclose such pay except in response to a formal complaint, investigation, or as otherwise permitted by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. We promote and support diversity, equity and inclusion. Job Requisition ID R0049196 Job Level Associate Director Full Time/Part Time Full‑Time Remote Type Onsite Required #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

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

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

* 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

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

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

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