Toxicology Scientist Job at CK Group (Warrington)

Senior Research Scientist - Toxicology

We are looking for a dynamic and detail-oriented Senior Research Scientist to jo...

Location

Canada , Vancouver

Salary:

112000.00 - 150000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

PhD in Toxicology or a related field, and a minimum of 5-8 years of related industry experience supporting biologics development
candidates with a MSc and 10+ years of relevant experience will also be considered
extensive hands-on experience with in vitro and/or in vivo toxicology studies
demonstrated proficiency with nonclinical safety assessment of large molecules/ biologics
strong organizational, critical problem-solving, and analytical skills to assess complex datasets and propose strategic solutions
excellent scientific writing, communication, and collaboration skills to effectively lead scientific discussions and influence decision-making
DABT accreditation (highly desirable, but not required)

Job Responsibility

Leading the design, planning, and oversight of in vitro safety and/or in vivo toxicology studies, ensuring alignment with global regulatory guidelines and strategic company objectives
Serving as a subject matter expert (SME) for Nonclinical Safety within cross-functional project teams, actively representing the function in internal and external stakeholder meetings
Providing critical assessment of complex toxicology data, translating and communicating clear, actionable risk-benefit evaluations and strategic recommendations to project teams and executive leadership
Maintaining comprehensive and meticulous recording of nonclinical safety study data as required by Good Laboratory Practice (GLP)
Authoring and critically reviewing the in vitro safety, toxicology, and safety pharmacology sections of Regulatory documentation (such as INDs, CTAs, IBs, and BLAs)
Collaborating seamlessly with scientists across various matrixed teams at AbCellera to ensure high data quality and accelerate program advancement
Contributing to the development of our toxicology programs and performing as a nonclinical safety/toxicology representative as needed
Maintaining an active scan and synthesis of published toxicology literature and evolving regulatory guidance relevant to AbCellera’s product portfolio, translating insights into internal best practices

What we offer

Equity
annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
annual vacation
professional development opportunities
comprehensive health benefits
Scientific and technical mentorship
strong sense of community and connections through work, clubs, and socials

Fulltime

Principal Scientist - Toxicology

We are looking for an experienced, strategically minded Principal Scientist to j...

Location

Canada , Vancouver

Salary:

134000.00 - 168000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

PhD in Toxicology or a related field, with 8+ years of relevant industry experience supporting biologics development
MSc degree and 12+ years of directly applicable experience will also be considered
deep expertise in GLP-compliant nonclinical toxicology
hands-on experience with US FDA 21 CFR Part 58
strong working knowledge of FDA, ICH, and EMA nonclinical regulatory guidance
proven track record of designing, overseeing, and interpreting non-GLP and GLP toxicology studies in support of discovery and development programs
ability to lead scientific discussions and influence decision-making within highly matrixed, cross-functional teams
excellent scientific writing skills
strong organizational and prioritization skills
sound scientific judgment and critical problem-solving skills

Job Responsibility

Leading the planning, design, execution and interpretation of nonclinical toxicology programs in support of IND, CTA and BLA submissions, including general toxicity and reproductive and developmental toxicology studies
serving as the primary scientific interface with contract research organizations (CROs)
representing the Nonclinical Safety function as a core member of cross-functional discovery and development program teams
providing critical scientific assessment of toxicology data and communicating clear, actionable risk-benefit evaluations and recommendations
authoring and reviewing nonclinical safety sections of regulatory documents (INDs, CTAs, IBs, and BLAs)
driving the development and evolution of integrated nonclinical safety strategies across AbCellera’s therapeutic portfolio
maintaining scientific leadership by staying current with advances in toxicology science

What we offer

Equity
annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
annual vacation
professional development opportunities
comprehensive health benefits
scientific and technical mentorship

Fulltime

Research Scientist II - Toxicology

We are looking for a dynamic and detail-oriented Research Scientist II to join o...

Location

Canada , Vancouver

Salary:

100000.00 - 125000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

PhD in Toxicology or related biological science field and a minimum of 2-5 years of related experience in an academic or industry environment
candidates with a MSc and 7+ years of relevant experience will also be considered
hands-on experience with in vitro and/or in vivo toxicology studies
strong desire to learn and develop proficiency with nonclinical safety assessment of large molecules/biologics
strong analytical and problem-solving skills
excellent communication and collaboration skills

Job Responsibility

Designing, planning, and supporting the execution of in vitro and/or in vivo toxicology studies as needed, adhering to the appropriate regulatory guidelines and communicating toxicology study results internally
Updating and maintaining proper recording of nonclinical safety study data, as required by Good Laboratory Practice (GLP)
Assisting with the authoring of toxicology sections of Regulatory documentation
Collaborating with scientists across various teams at AbCellera to ensure high data quality and that studies meet the company’s objectives
Contributing to the development of our toxicology programs and participating as a nonclinical safety/toxicology representative as needed
Maintaining an active scan of published toxicology data relevant to AbCellera’s product portfolio, and continuously expanding your knowledge base

What we offer

Equity
annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
annual vacation
professional development opportunities
comprehensive health benefits
scientific and technical mentorship

Fulltime

Assoc Scientist I-2

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Serve as a verifier of biocompatibility information documented in protocols, reports, toxicology risk assessments, BEP/BER or materials in the material database
Maintain the Material Database in Team Center Unified (TcU) and serve as the system administrator Validating software updates made to the material database
Generation of purchase orders for work performed at the external laboratories
Employ appropriate techniques/methods to execute routine assignments successfully and independently within negotiated deadlines
Maintain knowledge of relevant regulatory and biocompatibility requirements in accordance with ISO 10993 series of standards for device registration and global compendia for drug registrations
Recommend appropriate designs, techniques, and processes for a specified sequence of tasks where needed
Have a working knowledge and understanding of Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP) and related regulations and guidance
Receiving and handling samples for testing, coordinating sample shipments to external laboratories

Job Responsibility

Serve as a verifier of biocompatibility information documented in protocols, reports, toxicology risk assessments, BEP/BER or materials in the material database
Maintain the Material Database in Team Center Unified (TcU) and serve as the system administrator Validating software updates made to the material database
Generation of purchase orders for work performed at the external laboratories
Employ appropriate techniques/methods to execute routine assignments successfully and independently within negotiated deadlines
Maintain knowledge of relevant regulatory and biocompatibility requirements in accordance with ISO 10993 series of standards for device registration and global compendia for drug registrations
Recommend appropriate designs, techniques, and processes for a specified sequence of tasks where needed
Have a working knowledge and understanding of Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP) and related regulations and guidance
Receiving and handling samples for testing, coordinating sample shipments to external laboratories

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Assoc Scientist I

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Perform biological risk assessments to determine biocompatibility testing required to demonstrate product safety
Document risk assessments in Baxter qualified systems such as Team Center Unified (TCU), Trackwise 8, Electronic Laboratory Notebook (ELN)
Generate protocols and reports for biocompatibility testing
Manage biocompatibility testing at external laboratories within budget and according to project landmarks
Serve as a study monitor for studies placed at external laboratories and review protocols and reports
Summarize biocompatibility testing in technical documents that may be used for regulatory filing
Develop knowledge and understanding of ISO 10993 series of standards for executing biological assays and toxicological risk assessments per ISO 10993-17 for medical devices
Develop knowledge of global compendia (EX: USP, EP, JP etc) supporting container closure systems registered as drugs
Author BEP/BER for regulatory submissions
Have a working knowledge and understanding of Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP) and related regulations and guidance

Job Responsibility

Perform biological risk assessments to determine biocompatibility testing required to demonstrate product safety
Document risk assessments in Baxter qualified systems such as Team Center Unified (TCU), Trackwise 8, Electronic Laboratory Notebook (ELN)
Generate protocols and reports for biocompatibility testing
Manage biocompatibility testing at external laboratories within budget and according to project landmarks
Serve as a study monitor for studies placed at external laboratories and review protocols and reports
Summarize biocompatibility testing in technical documents that may be used for regulatory filing
Develop knowledge and understanding of ISO 10993 series of standards for executing biological assays and toxicological risk assessments per ISO 10993-17 for medical devices
Develop knowledge of global compendia (EX: USP, EP, JP etc) supporting container closure systems registered as drugs
Author BEP/BER for regulatory submissions
Have a working knowledge and understanding of Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP) and related regulations and guidance

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Assoc Scientist I

This is where new knowledge is discovered. Baxter's Research and Development tea...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Perform biological risk assessments to determine biocompatibility testing required to demonstrate product safety
Document risk assessments in Baxter qualified systems such as Team Center Unified (TCU), Trackwise 8, Electronic Laboratory Notebook (ELN)
Generate protocols and reports for biocompatibility testing
Manage biocompatibility testing at external laboratories within budget and according to project landmarks
Serve as a study monitor for studies placed at external laboratories and review protocols and reports
Summarize biocompatibility testing in technical documents for regulatory filing
Develop knowledge and understanding of ISO 10993 series of standards for executing biological assays and toxicological risk assessments per ISO 10993-17 for medical devices
Develop knowledge of global compendia (EX: USP, EP, JP etc.) supporting container closure systems registered as drugs
Author BEP/BER for regulatory submissions
Have a working knowledge and understanding of Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP) and related regulations and guidance

Job Responsibility

Perform biological risk assessments to determine biocompatibility testing required to demonstrate product safety
Document risk assessments in Baxter qualified systems such as Team Center Unified (TCU), Trackwise 8, Electronic Laboratory Notebook (ELN)
Generate protocols and reports for biocompatibility testing
Manage biocompatibility testing at external laboratories within budget and according to project landmarks
Serve as a study monitor for studies placed at external laboratories and review protocols and reports
Summarize biocompatibility testing in technical documents for regulatory filing
Develop knowledge and understanding of ISO 10993 series of standards for executing biological assays and toxicological risk assessments per ISO 10993-17 for medical devices
Develop knowledge of global compendia (EX: USP, EP, JP etc.) supporting container closure systems registered as drugs
Author BEP/BER for regulatory submissions
Have a working knowledge and understanding of Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP) and related regulations and guidance

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Assoc Scientist I

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Perform biological risk assessments to determine biocompatibility testing required to demonstrate product safety
Document risk assessments in Baxter qualified systems such as Team Center Unified (TCU), Trackwise 8, Electronic Laboratory Notebook (ELN)
Generate protocols and reports for biocompatibility testing
Manage biocompatibility testing at external laboratories within budget and according to project landmarks
Serve as a study monitor for studies placed at external laboratories and review protocols and reports
Summarize biocompatibility testing in technical documents for regulatory filing
Develop knowledge and understanding of ISO 10993 series of standards for executing biological assays and toxicological risk assessments per ISO 10993-17 for medical devices
Develop knowledge of global compendia (EX: USP, EP, JP etc.) supporting container closure systems registered as drugs
Author BEP/BER for regulatory submissions
Have a working knowledge and understanding of Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP) and related regulations and guidance

Job Responsibility

Perform biological risk assessments to determine biocompatibility testing required to demonstrate product safety
Document risk assessments in Baxter qualified systems such as Team Center Unified (TCU), Trackwise 8, Electronic Laboratory Notebook (ELN)
Generate protocols and reports for biocompatibility testing
Manage biocompatibility testing at external laboratories within budget and according to project landmarks
Serve as a study monitor for studies placed at external laboratories and review protocols and reports
Summarize biocompatibility testing in technical documents for regulatory filing
Develop knowledge and understanding of ISO 10993 series of standards for executing biological assays and toxicological risk assessments per ISO 10993-17 for medical devices
Develop knowledge of global compendia (EX: USP, EP, JP etc.) supporting container closure systems registered as drugs
Author BEP/BER for regulatory submissions
Have a working knowledge and understanding of Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP) and related regulations and guidance

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Assoc Scientist I-2

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Serve as a verifier of biocompatibility information documented in protocols, reports, toxicology risk assessments, BEP/BER or materials in the material database
Maintain the Material Database in Team Center Unified (TcU) and serve as the system administrator Validating software updates made to the material database
Generation of purchase orders for work performed at the external laboratories
Employ appropriate techniques/methods to execute routine assignments successfully and independently within negotiated deadlines
Maintain knowledge of relevant regulatory and biocompatibility requirements in accordance with ISO 10993 series of standards for device registration and global compendia for drug registrations
Recommend appropriate designs, techniques, and processes for a specified sequence of tasks where needed
Have a working knowledge and understanding of Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP) and related regulations and guidance
Receiving and handling samples for testing, coordinating sample shipments to external laboratories

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

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Toxicology Scientist

Job Description

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