PK Scientist Job at iconplc

Scientist, LCMS PK Bioanalytical

An exciting opportunity is available for a Scientist to join the PK LCMS group i...

Location

United States , Andover

Salary:

79400.00 - 128500.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

MS with 4 to 6 years of relevant work experience, ideally mostly in industry (or BS/BA with 6 to 8 years of experience)
Expertise in development, characterization, and implementation of bioanalytical LCMS assays
Experience in the operation and troubleshooting of LCMS instrumentation and associated operating/data analysis software including Skyline, Analyst, Sciex OS and Xcalibur
Hands-on experience of biological sample preparation procedures for quantitative LCMS assays on biotherapeutics
Knowledge of writing scripts to set up methods for automated liquid handler system
Knowledge of protein biochemistry of therapeutic antibodies, fusion proteins or ADCs

Job Responsibility

Responsible for the development, qualification and implementation of PK/PD assays using mass spectrometry in support of discovery and preclinical projects
Works with group leads or other discovery and regulated bioanalytical team members and project team members to accomplish goals
Participates in technology development and implementation by exploring new workflows, including automation, high throughput sample preparation and instrumentation in protein quantitation, to expand the group’s PK LCMS bioanalytical capabilities
Participate in all phases of mass spectrometry laboratory operations including technology evaluations, the development of sample preparation and separation methods, data analysis, interpretation, reporting and follow up discussions with the project teams on utilizing the data in appropriate decision making
Ensure all tasks and responsibilities are carried out according to scientific and ethical standards e.g. responsible for electronic notebook record keeping
QC and peer review of data and reports

What we offer

401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
paid vacation, holiday and personal days
paid caregiver/parental and medical leave
health benefits to include medical, prescription drug, dental and vision coverage
bonus target of 7.5% of the base salary
Relocation assistance may be available

Fulltime

Senior Research Scientist – Pharmacokinetics

We are seeking a highly motivated Senior Research Scientist with a strong unders...

Location

Canada , Vancouver

Salary:

112000.00 - 132000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

Expert in the design, development, and phase-appropriate qualification/validation of LC/MS-MS bioanalytical assays to support preclinical and clinical development
Demonstrated expertise in authoring sections of regulatory submissions
Comfortable with non-compartmental data analysis (WinNonlin), and have a good understanding of PK parameters
8+ years of relevant industry experience in addition to a PhD in Biology, Pharmacology, or related discipline
candidates with a MSc and 10+ years of industry experience will also be considered
Genuinely curious and energized by working with teammates to discuss innovative ideas in a highly collaborative and fast paced environment
Excel in documentation and organizational skills and clearly communicate scientific and technical concepts both verbally and in writing

Job Responsibility

Leading external activities for establishing, qualifying, and validating ligand-binding assays and LC-MS/MS methods to support the preclinical and clinical development of novel ADC therapeutics, including measurement of drug concentration and anti-drug antibodies
Characterizing the ADME profile for ADC candidates, including assessing the drug-drug interaction (DDI) potential of released small molecule payloads
Leading the analysis, interpretation, and reporting of PK/ADME data to support regulatory filings (IND/CTA), including authoring and reviewing high-quality study reports, briefing packages, and regulatory documents
Collaborating with cross-functional project teams where you'll represent the PK function, and interacting externally with CROs or consultants
Training and mentoring scientists

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
Opportunity for flexible work arrangements
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship
Strong sense of community and connections through work, clubs, and socials

Fulltime

Scientist III

Scientist III- Full Time- Onsite; Whitesboro, New York- Large Molecule and Bioma...

Location

United States , Whitesboro

Salary:

75480.00 - 94350.00 USD / Year

iconplc

Expiration Date

Until further notice

Requirements

Atleast 5 years of working experience in biomarker space
Prior experience with ELISA, ELLA, ECLIA, MSD, etc.
Working experience with method development, method validation, and method transfer
Background in Biology, Microbiology, Chemistry, Biochemistry, etc. or degree in similar field
Experience/Exposure to working with large molecules

Job Responsibility

Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance
As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
Travel (approximately 5%) domestic and/or international
Conduct and document PK/PD data analysis activities within the PK, PD, M&S group
Provide status updates of work in progress and estimate time needed for various tasks
Build and great relationships with department members and clients to ensure optimal service and deliverables
Identify issues and/or problems as appropriate, and propose and help implement workable solutions
Work with the Project Manager to prepare timelines for all procedures/tasks/goals and their completion dates
Attend team meetings as appropriate
Prepare scientific publications to support endeavors in new science, and attend seminars and workshops to expand professional capabilities

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Bioanalytical Portfolio Scientist

In this vital role you will serve as the technical subject matter expert for out...

Location

United States

Salary:

109020.15 - 147497.85 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 2 years of regulated commercial scientific laboratory experience OR Bachelor's degree and 4 years of regulated commercial scientific laboratory experience OR Associate's degree and 8 years of regulated commercial scientific laboratory experience OR High school diploma / GED and 10 years of regulated commercial scientific laboratory experience

Job Responsibility

Serve as the technical subject matter expert for outsourced methods and is responsible to ensure adequate method validation and optimal method performance at CROs
Provides scientific and technical oversight for the transfer, validation, and execution for pharmacokinetic (PK) assays, ensuring adherence to sponsor requirements and current regulatory guidance on bioanalytical assays (e.g. FDA, ICH, EMEA, NMPA)
Leads the transfer and validation of PK assays at external CROs using ligand-binding, ELISA, ECL, LC-MS/MS and hybrid methodologies
Collaborates closely with internal bioanalytical subject matter experts to understand critical attributes of the PK method to ensure successful assay transfer and validation
Monitors assay performance over time and provides input for troubleshooting and continuous improvement efforts
Accountable for method lifecycle management, including review of method validation plans, protocols, reports, and qualification/bridging of reagents and reference material
Reviews analytical data, method protocol, validation/sample analysis plans, reports, and other study documentation for scientific accuracy and consistency with GLP/GCP documentation standards and current regulatory guidance
Works with cross functional partners from CROs to navigate issue resolution and escalation utilizing the governance structure
Provides subject matter expertise during supplier evaluation and monitoring activities
Follows and contributes to guidance documents and SOPs

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Global Development Product Lead

Leads multiple cross functional oncology product teams from pre-clinical candida...

Location

United States , La Jolla; Cambridge; Bothell; South San Francisco; New York City

Salary:

295900.00 - 478800.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

MD or MD-PhD with 10+ years of industry experience in oncology drug development is preferred, track record in oncology clinical research including early phase drug development
Clinical oncology experience: Board certification in oncology preferred
Significant industry leadership experience in clinical, translational or basic research in biomedical sciences or one of the disciplines related to drug development
Understanding of related disciplines (e.g., biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)
Demonstrated scientific productivity (publications, abstracts, etc.)
Proven scientific writing skills and good communication skills
Proven leadership skills with ability to defend the clinical plan at governance meetings is essential
Capacity to adapt to a fast-paced and changing environment
Demonstrated history of effective leadership
including cross functional and matrixed teams, managing direct reports when applicable, and experience in seeking and maintaining alignment with cross-functional leaders

Job Responsibility

Leads multiple (~2-4) cross functional oncology product teams from pre-clinical candidate nomination (CAN) through Phase 1-2 clinical development and proof of concept (POC) stages
In close collaboration with functional experts on the product teams, drives the effective integration of an end-to-end cross functional molecule strategy and risk mitigation plan and ensures delivery of data-driven milestones through successful risk identification and mitigation
Support clinical trials and the development strategy for early development assets and lead development programs across multiple functions within Pfizer Oncology, as well as represent the program with the external clinical community
Develop clinical development plan from first in human clinical trial to proof-of-concept, including assessment of appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans
To ensure the cross-functional components of the product plans including clinical expertise are provided to project teams, including medical monitoring of clinical trials
Substantial support of CDP development and diligence for external innovation activities
Lead key enterprise level cross-functional workstreams to accelerate R&D decision making
Lead, develop and execute strategic development for early development assets
Ensure timely execution and delivery of product milestones within budget
Communicate with executive management and governance committees to address program needs and provide recommendations

What we offer

Participation in Pfizer’s Global Performance Plan with a bonus target of 30.0% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility

Fulltime

Scientist / Senior Scientist, DMPK

An exciting opportunity is available for an enthusiastic and highly-skilled Scie...

Location

United States , San Francisco Bay Area; San Diego

Salary:

132500.00 - 247200.00 USD / Year

Altos Labs

Expiration Date

Until further notice

Requirements

PhD in Chemistry, Biology, Pharmaceutical Sciences, or a related field and 3+ years of relevant work experience
Strong fundamental knowledge of DMPK and ADME
Working knowledge of ADME assays and bioanalysis, leveraged to design studies and interpret data
Ability to evaluate in vitro-in vivo correlation of drug candidates across preclinical species
Ability to generate NCA and compartmental PK models
general knowledge of mechanistic modeling concepts (e.g., PBPK)
Ability to communicate DMPK results in a timely, clear, and impactful manner to non-DMPK scientists
Exceptional organizational skills, attention to detail, time management, and ability to work independently and collaboratively
Willingness to gain new knowledge and apply it to support multiple therapeutic modalities

Job Responsibility

Serve as the DMPK representative on cross-disciplinary preclinical project teams, providing strategic and data-driven DMPK guidance to advance portfolio programs
Plan, manage, and oversee ADME and PK studies executed with external CRO partners
Partner with Medicinal Chemistry to develop ADME- and PK-driven SAR strategies to optimize candidate properties and progression
Collaborate with Pharmacology and the internal DMPK bioanalysis group to design, execute, and interpret preclinical PK/PD, target engagement, and efficacy studies
Calculate the projected efficacious human dose to support IND-enabling development and regulatory submissions
Provide DMPK support to early-stage, pre-portfolio discovery programs, helping shape strategy and experimental plans
Advise and train the DMPK bioanalysis team to support internalization and implementation of select ADME assays
Stay current on emerging DMPK science and best practices through literature review and participation in relevant scientific meetings

Fulltime

Scientific Associate Director - Pharmacokinetics and Drug Metabolism

In this vital and exciting role, you will oversee Pharmacokinetics and Drug Meta...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

PhD in Pharmacokinetics, Pharmaceutical Sciences, Engineering, or related fields with equivalent professional degrees and 12+ years of experience in the Biotechnology/Pharmaceutical Industry
Solid technical experience with the application of SM in vitro/in vivo ADME and pharmacokinetics fundamentals to drug discovery projects
Ability to drive the progression of SM discovery and development within project teams
Expertise with in vitro ADME, in vivo ADME, PK/PD etc
Experience in supporting preclinical components of regulatory documentations
Excellent interpersonal, technical, and communication skills
Past experience as a laboratory scientist in a pharma or biotech environment
Excellent written and oral communication skills, attention to detail and accuracy, and interpersonal skills
Record of scientific contributions through peer-reviewed articles and external presentations

Job Responsibility

Lead/mentor a team of scientists involved in ADME characterization of small molecules
Directly responsible for leading a team of scientists involved in undertaking mechanistic in vitro ADME assays
Develop/implement novel tools to efficiently support mechanistic ADME work
Oversee activities/establish workflows for small molecule bioanalytical and ADME screening teams
Serving as a subject matter expert of small molecule ADME to support the programs and recommend strategies to PKDM project team representatives to reduce/mitigate risks due to metabolism
Collaborate with scientists across our PKDM scientific community
Leveraging specialized ADME/PK skills such as in vitro ADME, in vivo ADME, biotransformation, PK/PD, to impact project progression and decision-making
Contributing to the analysis of pre-clinical ADME and PK data for IND and NDA filings and documenting these analyses in appropriate reports
Building close relationships with partner functions

New

IT Training Lead

The IT Training Lead will drive technology learning and user adoption across the...

Location

United States , Delray Beach

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Experience in IT training, instructional design, technical enablement, or learning and development
Strong knowledge of Microsoft 365
Excellent communication, facilitation, and content development skills
Ability to translate technical concepts into practical, user-friendly training.

Job Responsibility

Design, develop, and deliver IT training programs in instructor-led, virtual, and self-paced formats
Take lead in the Microsoft Copilot and AI training strategy, including onboarding, advanced use cases, responsible AI usage, and ongoing enablement
Partner with IT leadership to support new technology rollouts, system upgrades, and digital transformation initiatives
Create and maintain training content, including videos, guides, tutorials, and job aids
Identify skill gaps and develop targeted learning solutions to improve adoption and productivity
Gather feedback and measure training effectiveness to continuously improve programs.

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PK Scientist

Job Description

Job Responsibility

Requirements

What we offer

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