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:
Supply Chain Manufacturing
Job Sub Function:
Manufacturing Deployment
Job Category:
Professional
All Job Posting Locations:
New Brunswick, New Jersey, United States of America
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine
We are searching for the best talent for a Senior Scientist, Process Validation to be based New Brunswick, New Jersey. Alternative locations include Raritan, New Jersey.
Our Global Focus in Advanced Therapies
Advanced therapy medicinal products (ATMPs), including CAR-T and viral vector-based treatments, represent a transformative approach to patient care. As a global organization, we strive to harmonize validation strategies, ensuring consistency, compliance, and innovation throughout our manufacturing network.
The Process Validation Center of Excellence
The CoE provides strategic leadership for validation activities and governance standards to drive accountability across partners. We define standard processes, drive harmonization, and enable technology adoption to ensure robust, validated processes that meet regulatory expectations and deliver life-changing therapies to patients worldwide.
Role Summary
The Senior Scientist serves as a key member of the global Life Cycle Management team, responsible for developing, implementing, and governing validation strategies across the Advanced Therapies network. This role focuses on global alignment, standardization of validation approaches, and strategic oversight of Tech Transfer, PPQ campaigns, CPV programs, and digital readiness. This role partners closely with regional MSAT, R&D, Quality, Regulatory, and Engineering teams to ensure consistent, compliant, and innovative validation practices globally.
Operational Excellence & Governance
Define and maintain global Validation Master Plans and governance frameworks for ATMP processes.
Drive global implementation of risk-based validation approaches aligned with ICH Q8/Q9/Q10, Annex 15, and FDA/EMA guidance.
Author harmonized validation standards and templates across the global network.
Provide strategic oversight for PPQ campaigns implemented at multiple sites, ensuring consistency and compliance.
Support global CPV strategy, apply data analytics, statistical tools, and risk management principles to evaluate process capability and drive data-informed decisions.
Support lifecycle improvement initiatives and evaluate digital tools for process monitoring.
Partner with regional and site teams to assess validation readiness for new technologies and platforms.
Support and author regulatory submissions with globally aligned validation documentation and strategies.
Cross-Functional Leadership & Communication
Act as an inspiring leader, mentoring teams and influencing global validation policy and innovation.
Facilitate collaboration and communicate program goals, progress, risks, and results to senior leadership and technical teams with clarity and influence.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s)
United States -
Requisition Number: R-048421
Belgium - Requisition Number: R-049802
Ireland - Requisitions Number: R-049778
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Required Qualifications:
Education:
Bachelor's degree in biology, biotechnology, or related scientific field is required; advanced degree or equivalent experience preferred.
Skills & Experience:
7+ years proven experience within a regulated biologics or pharma industry
Experience in global process validation strategy, governance, and regulatory compliance for ATMPs.
Strong understanding of risk-based validation principles and Health Authority expectations.
Demonstrate the ability to work effectively in cross-functional environment and influence global teams
Preferred Qualifications:
Prior experience in cell culture or viral vector commercial manufacturing is highly desired.
Knowledge in statical process control and analytical data modeling.
Experience in digital solution implementation and deployment.
Knowledge in data management platforms and data governance
Other Requirements:
International travel to partner sites and global meetings, up to 20% of the time. Flexibility to work remotely when not travelling.
Language requirements - fluency in English required; additional languages preferred.
The anticipated compensation rage for this position is 94,000-144,500
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ********************
Required Skills:
Preferred Skills:
Agile Manufacturing, Business Process Design, Coaching, Communication, Critical Thinking, Good Manufacturing Practices (GMP), Innovation, Manufacturing Engineering, Manufacturing Flow Management, Manufacturing Processes, Plant Operations, Proactive Behavior, Problem Solving, Product Development Lifecycle, Production Operations, Profit and Loss Responsibility, Robotic Automation, Structural Fabrication, Sustainability
The anticipated base pay range for this position is :
94,000-144,500
Additional Description for Pay Transparency:
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
$72k-99k yearly est. Auto-Apply 27d ago
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Lead In Vitro Pharmacology Scientist - GPCR Drug Discovery
Crinetics Pharmaceuticals, Inc. 3.9
San Diego, CA jobs
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.
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$158k-197k yearly 1d ago
Sr. Principal Scientist
The University of Texas Md Anderson Cancer Center 4.3
Boston, MA jobs
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
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$136.8k-189.2k yearly 3d ago
Lead Scientist, In Vitro Antibody Display & Discovery
Eli Lilly and Company 4.6
San Diego, CA jobs
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.
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$110.3k-187k yearly 5d ago
R&D Scientist
EPM Scientific 3.9
Chicago, IL jobs
Are you passionate about science and organization? We're looking for a hands-on scientist who can also drive project coordination across R&D and analytical initiatives. This role blends technical expertise with leadership in planning and communication.
What You'll Do
Track and manage R&D and analytical projects, ensuring timelines and priorities are met.
Maintain project dashboards and prepare concise progress updates for leadership.
Support formulation experiments, sample prep, and analytical testing (HPLC, dissolution, stability).
Collaborate with QA, Regulatory, and Operations to align deliverables.
Recommend process improvements and help implement standardized tools.
What We're Looking For
Education: Bachelor's or Master's in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
Experience: 3-6 years in pharmaceutical R&D, analytical chemistry, or formulation science.
Familiarity with HPLC and method development.
Strong organizational and communication skills.
Comfortable balancing lab work with coordination responsibilities.
Why Join Us
Competitive salary + comprehensive benefits.
Health, dental, vision coverage.
Retirement plan with company match.
Paid time off and holidays.
Collaborative, science-driven environment.
$70k-96k yearly est. 1d ago
Lead Scientist, In Vitro Antibody Discovery
Eli Lilly and Company 4.6
San Diego, CA jobs
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.
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$120k-159k yearly est. 1d ago
Senior ICS Cybersecurity Research Scientist
Hitachi Automotive Systems Americas, Inc. 3.9
Raleigh, NC jobs
A leading technology firm is seeking a Senior Cyber Security Research Scientist to develop security architecture for industrial control systems. This role involves advising R&D units on security weaknesses and monitoring the IT/OT security landscape. Candidates should have a doctorate or relevant master's degree, with experience in software development and excellent communication skills. Competitive benefits and opportunities for personal growth are offered.
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$65k-90k yearly est. 5d ago
Metallurgical R&D Scientist
HTI 4.3
Augusta, GA jobs
HTI is seeking a Metallurgical R&D Scientist for a brand-new facility in Augusta, GA. This is a great opportunity to work with a state-of-the-art facility and be an important contributor to the growing North American metals supply chain.
What They Offer
Full Medical, Dental, and Vision Benefits on Day 1
401(k) Match
EAP, LTD, STD, and Life Insurance
Competitive Vacation Package
12 Paid Holidays
Relocation Assistance Available
What You Need
Bachelor's Degree in Chemical Engineering, Materials Science, Metallurgy, or a related field
Minimum of 2 years of experience, ideally in R&D, materials analysis, or process engineering
Recent graduates with relevant project or lab experience may be considered
Strong understanding of non-ferrous metallurgy and metal extraction principles, especially copper metallurgy.
Knowledge of pyrometallurgical, hydrometallurgical, and/or electrometallurgical processes
Experience with:
Material characterization and analysis
Process troubleshooting and optimization
Failure analysis and root cause investigation
Familiarity with process simulation or thermodynamic modeling tools (FactSage, Thermo-Calc, HSC, etc.) is preferred but not required
Experience preparing or interpreting process flow diagrams, phase diagrams, and thermodynamic calculations
**Candidates must be eligible to work in the U.S. without sponsorship now AND in the FUTURE**
What Your Role Will Look Like
As the Metallurgical Research & Development Scientist, you will be integral to the development and enhancement of metallurgical processes, particularly in non-ferrous extractive metallurgy with a focus on copper. Collaborating with various departments, you will lead process improvement initiatives through simulation and modeling, contribute to R&D projects, and support the broader organization in achieving its production and efficiency goals.
Key Responsibilities
Collaborate closely with cross-functional teams, including Production, Supply Chain, and Maintenance, to develop and optimize metallurgical processes.
Design and improve processes through simulation, focusing on enhancing production efficiency and effectiveness.
Conduct research and development projects, such as developing new copper alloys and analyzing the impact of using different types of electronic waste.
Utilize process simulation software to model and simulate metallurgical processes, implementing improvements to existing operations.
Prepare detailed process flow diagrams and perform calculations related to mass balance, heat balance, and phase diagrams.
Support other departments by providing expertise on chemical and material compositions and addressing process-related questions.
Ensure compliance with environmental, health, and safety standards, contributing to the development of operating instructions and risk assessments.
Participate in the ongoing development of R&D labs on-site, with a focus on future process improvements and innovations.
$52k-74k yearly est. 1d ago
Sr. Scientist - Beverages
Kerry 4.7
Clark, NJ jobs
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
We are seeking a highly skilled and innovative RD&A Scientist to join our Beverage team. This role is responsible for developing and optimizing beverage formulations across various formats including sparkling, still, juice, and functional beverages. The ideal candidate will bring deep technical expertise, strong sensory capabilities, and a collaborative mindset to drive product innovation and meet customer expectations.
Key responsibilities
Develop and prepare beverage formulations, syrups, and concentrates at lab and pilot plant scale.
Test and refine formulations to meet specific taste profiles and regulatory standards.
Customize beverage ingredients independently or within cross-functional teams.
Calculate calories and understand the role of sweeteners and nutrients in formulations.
Facilitate sample shipments for internal and external stakeholders.
Support beverage and taste development under GMP and safety standards.
Manage multiple tasks and deadlines with speed and accuracy.
Master formulation techniques for RTD (Ready-to-Drink) and RTM (Ready-to-Make) formats.
Apply exceptional sensory skills to define and discriminate flavor profiles under tight timelines.
Demonstrate a deep understanding of beverage processing techniques and nutritional value calculations.
Communicate formulation concepts effectively in commercial settings with customers.
Apply mathematical skills to work with dilutions, percentages, and ppm calculations.
Exhibit self-motivation and resourcefulness in solving complex formulation challenges.
Qualifications and skills
Bachelor's Degree in Food Science, Biology, Chemistry, or a related Applied Science.
Minimum of 5 years of experience in beverage development and formulation.
Strong scientific and analytical aptitude.
Proficiency in Microsoft Office; experience with SAP is a plus.
Excellent problem-solving skills and ability to work independently and collaboratively.
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).
Beware of scams online or from individuals claiming to represent us. A Kerry employee will not solicit candidates through a non-Kerry email address or phone number. In addition, Kerry does not currently utilise video chat rooms (e.g., Google Hangouts) to conduct interviews. Refuse any request that asks you to provide payment to participate in the hiring process (e.g., purchasing a “starter kit,” investing in training, or something similar). Kerry will not ask you to pay any money at any point in the hiring process with the exception of reimbursable travel expenses. In addition, any payments made by Kerry will be from official firm accounts bearing the Kerry name.
$75.6k-123.4k yearly 3d ago
Global Head of Data & Quantitative Science Delivery
Takeda 4.7
Boston, MA jobs
A global leader in biopharmaceuticals seeks a Head of Design & Delivery for Data & Quantitative Sciences to spearhead innovations in R&D technology. This role involves shaping a strategic product roadmap across data science, managing a global team, and ensuring compliance in product development. Candidates should possess significant experience in pharmaceutical R&D technology, with strong leadership and communication skills. A competitive compensation package is offered, including salary and benefits.
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$91k-125k yearly est. 2d ago
Sr. RD&A Scientist - Beverages
Kerry 4.7
Beloit, WI jobs
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
Kerry is seeking a Research, Development and Application Senior Scientist for a key role supporting the growth of the North American Beverage market. This position is based at the KERRY Global Technology & Innovation Centre in Beloit, Wisconsin, USA, reporting to the RD&A Director/Manager and is responsible for executing on the business strategy by creating market relevant and differentiated products that meet the requirements of customers and consumers, utilizing Kerry's broad and industry leading portfolio of technologies.
This role is part of a team of RD&A Scientists and Technicians that are responsible for the development of powder and liquid beverage concepts.
Strong communication and leadership skills are critical as the day-to-day activities involve significant cross-functional collaboration with Flavorists, Nutrition Scientists, Regulatory, Marketing, Sales, and Finance.
Key responsibilities
Lead formulation and concept development from end-to-end on internal and customer projects within North America for the Beverage market.
Use sound commercial and technical awareness of ingredients, processes, end use market and customer requirements to deliver on project objectives, across powder beverages and liquid beverage product formats.
Develop innovative solutions to help grow customers and Kerry's market share within cost parameters and manufacturing capabilities while ensuring all new products are legal within country of use.
Manage Pilot Plant validation work and facilitate first production trials of new products internally and with third part manufacturers.
Build strong relationships with customer contacts via clear communication, on-site and virtual visits, presentations and supporting trials when required.
Support sales and business representatives during customer calls through technical presentations and product demonstrations.
Work within cross-functional teams to optimize the strengths of Kerry and deliver the best Taste and Nutrition experience for our customers.
Study methods to improve quality of products such as flavour, colour, texture, nutritional value, as well as physical, chemical, and microbiological composition.
Qualifications and skills
BSc/MSc/PhD in Food Science, Food Engineering, or related field.
5+ years of hands-on experience in product development, preferably beverages products.
Experience working with 'functional ingredients' is a plus - probiotics, adaptogens, botanical extracts, etc.
Working knowledge of the beverage market in North America.
Proven success in product development resulting in successful market launch.
Curiosity and a willingness to push creative boundaries.
Strong team-player, with excellent interpersonal, organizational, communication and project management skills.
Knowledgeable about food chemistry, sensory, microbiology, food packaging systems and food engineering.
The pay range for this position is 75,602- 123,432 in Annual Salary. Kerry typically does not hire an individual at the top or near the top of the range, as we are a pay-for-performance company, and this range is set to continue to reward performance annually while in role. Compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate within the above range may be influenced by a variety of factors including skills, qualifications, experience, and internal equity. Kerry offers a competitive benefits package, including medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, Employee Share Plan, Life, disability, and accident insurance, and tuition reimbursement. This job posting is anticipated to expire on Dec 27, 2025.
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).
Beware of scams online or from individuals claiming to represent us. A Kerry employee will not solicit candidates through a non-Kerry email address or phone number. In addition, Kerry does not currently utilise video chat rooms (e.g., Google Hangouts) to conduct interviews. Refuse any request that asks you to provide payment to participate in the hiring process (e.g., purchasing a “starter kit,” investing in training, or something similar). Kerry will not ask you to pay any money at any point in the hiring process with the exception of reimbursable travel expenses. In addition, any payments made by Kerry will be from official firm accounts bearing the Kerry name.
$80k-108k yearly est. 5d ago
Food Scientist - Dairy flavor
Kerry 4.7
Beloit, WI jobs
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
We are seeking a passionate and technically skilled Dairy Scientist to join our R&D team. In this role, you will leverage your expertise in dairy science, food technology, microbiology or related fields to develop, optimize, and support innovative dairy products and solutions. You will collaborate closely with cross-functional teams-including product development, process engineering, and commercial teams-to deliver high-quality, market-leading dairy flavors.
Key responsibilities
Develop and optimize flavor formulations for a variety of dairy products (e.g., yogurt, cheese, beverages, desserts) through the use of cultures, enzymes, materials and processes.
Lead application trials and pilot plant runs to validate new concepts and processes.
Collaborate with customers and internal teams to understand requirements and deliver tailored solutions.
Troubleshoot formulation and processing challenges, providing technical support to both internal stakeholders and customers.
Stay current with industry trends, new ingredients, and processing technologies relevant to dairy applications.
Document and communicate findings, protocols, and recommendations clearly and effectively.
Support commercialization efforts by scaling up successful prototypes and assisting with plant trials.
Ensure all work complies with food safety, quality, and regulatory standards.
Qualifications and skills
Bachelor's or Master's degree in Food Science, Dairy Science, Chemical Engineering, Microbiology or a related field.
3+ years of experience in dairy product development or applications (internships and co-ops considered).
Strong knowledge of dairy ingredients, processing technologies, and product functionality.
Hands-on experience with pilot plant equipment and laboratory analysis.
Excellent problem-solving skills and attention to detail.
Strong communication and teamwork abilities.
Ability to manage multiple projects and adapt to changing priorities.
Willingness to travel as needed (up to 20%)}
Experience working directly with customers or in a B2B environment.
Familiarity with regulatory requirements for dairy products.
The typical hiring range for this role is $91,311 to $149,080 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).
Beware of scams online or from individuals claiming to represent us. A Kerry employee will not solicit candidates through a non-Kerry email address or phone number. In addition, Kerry does not currently utilise video chat rooms (e.g., Google Hangouts) to conduct interviews. Refuse any request that asks you to provide payment to participate in the hiring process (e.g., purchasing a “starter kit,” investing in training, or something similar). Kerry will not ask you to pay any money at any point in the hiring process with the exception of reimbursable travel expenses. In addition, any payments made by Kerry will be from official firm accounts bearing the Kerry name.
$47k-73k yearly est. 1d ago
Principal Scientist - Quality Control Lead, Small Molecules
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
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
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$195.7k-253.2k yearly 2d ago
Associate Director/Principal Scientist
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
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.
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$116k-163k yearly est. 1d ago
Principal Scientist, Quality Control Biologics (Microbiology)
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
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.
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Job Requisition ID R0044329
Full Time/Part Time Full-Time
Job Level Associate Director
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$126k-178k yearly est. 1d ago
Principal Scientist, QC Microbiology (Biologics)
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
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.
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$126k-178k yearly est. 1d ago
Principal Scientist, Analytical Ops
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
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.
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$126k-178k yearly est. 1d ago
Lead Target Discovery Scientist - In Vitro Biology
Amgen Sa 4.8
Thousand Oaks, CA jobs
A leading biotech company in Thousand Oaks seeks a Senior Principal Scientist to lead a team focused on in vitro modeling for target discovery. This role involves collaboration across therapeutic areas and implementing innovative technologies. Candidates should have a doctorate and extensive experience in a related field. Competitive compensation, flexible work models, and a comprehensive benefits package are offered.
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$125k-173k yearly est. 1d ago
Senior Oncology Bioinformatics Scientist
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
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.
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$88k-133k yearly est. 4d ago
Primary Toxicologist - MedTech Surgery, Inc.
Johnson & Johnson 4.7
Scientist job at Johnson & Johnson
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:
Nonclinical Safety
Job Category:
Scientific/Technology
All Job Posting Locations:
Cincinnati, Ohio, United States of America
Job Description:
About Surgery
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech
We are searching for the best talent for a Primary Toxicologist. This role will work a Flex/Hybrid schedule with 3 days per week on-site & must be based within a commutable distance of Cincinnati, OH. Relocation assistance is available to qualified candidates.
Purpose: The Primary Toxicologist will make vital contributions to Front End Innovation, New Product Development, and Life Cycle Management. They are responsible for working with project teams and cross-functional partners on material-centric aspects of our products to ensure patient safety, regulatory compliance, and manufacturing consistency.
You will be responsible for:
* Evaluating medical device products for safety in compliance with internal procedures, US and international regulations, and ISO 10993.
* Serving as the sponsor for applicable GLP and non-GLP studies, ensuring the studies are of high quality, completed on time, and comply with regulations and procedures.
* Assisting in the design and implementation of biocompatibility evaluations, toxicology risk assessments, and procedures for Ethicon and across Johnson & Johnson MedTech.
* Reviewing, interpreting, and summarizing toxicological and material chemistry raw data from reports.
* Applying technical expertise to solve complex biocompatibility problems, utilizing ingenuity and business experience.
* Ensuring appropriate documentation is established and maintained to support that the biocompatibility and toxicity testing meets all US and international test requirements per ISO, FDA (US Food and Drug Administration), and GLP (Good Laboratory Practices) regulations.
* Collaborating closely and providing consultative technical expertise to cross-functional partners, including Research & Development, Clinical Affairs, Regulatory Affairs, Surgical R&D, and Supplier Management.
Qualifications / Requirements:
* Minimum of a Master's degree in Biology, Chemistry, Biomedical Engineering, or a closely related scientific field required. Ph.D. in toxicology or closely related scientific field strongly preferred.
* At least of 1-3+ years of professional experience in biocompatibility assessment and evaluation in medical device, pharmaceutical, and/or consumer products required.
* Ability to work collaboratively as a team member across various functions in a challenging and changing environment.
* Experience working in a regulated environment of medical device safety and supporting product submission and audit.
* Proven experience with project management skills, leading safety evaluation for multiple projects, managing priorities and time management.
* Skilled verbal and written communication of issues and technical concepts in a clear, concise manner.
* Proactive, self-motivated performer in an unsupervised environment.
* Proficient use of the Microsoft Office suite (Word, Excel, PowerPoint, Outlook).
* Experience supporting product registration is multiple global markets preferred.
* Strong knowledge of biocompatibility assessment methods for medical devices and previous knowledge of how to conduct and assist in the interpretation of in vitro, ex vivo, and in vivo studies preferred.
* Familiarity with medical device product development and design controls preferred
* Requires up to 10% travel, domestic and international 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 & 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 contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource.
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Required Skills:
Preferred Skills:
Biocompatibility, Clinical Toxicology, Collaborating, Detail-Oriented, Laboratory Experiments, Process Control, Process Hazard Analysis (PHA), Process Oriented, Report Writing, Safety Audits, Safety Investigations, Safety-Oriented, Scientific Research, Technical Writing, Technologically Savvy, Toxicology, Toxicology Research, Troubleshooting
The anticipated base pay range for this position is :
$76,000.00 - $121,900.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year