Synectics Inc.
Job Description
As Principal Scientist PMed Operations Specialising in Biomarker Bioanalytical Platforms (BBP), you will lead planning activities across various scientific lab groups in BBP for all BBP-owned measures (Pharmacokinetics, Immunogenicity including ADA and NAb, PD Biomarkers, Diagnostic Biomarkers, and Exploratory Biomarkers) to support clinical study milestones.
You will act as an operations BBP contact for asset-driven clinical study/project teams on all planning activities, including analytical timelines, budgeting, and scientific coordination.
Lead planning activities across various scientific lab groups in BBP for all BBP owned measures to support clinical study milestones.
Coordinate the bioanalytical portion of clinical study support conducted in-house or at CROs, focusing on required clinical assay measure deliverables, resource and budgetary requirements, and protocol review for contract generation.
Oversee the coordination of assay requirements, reagent development, resource placement, and performance tracking for clinical studies.
Work with Project Managers to deliver an accurate project plan for clinical study assay measures, provide budget and resource forecasting, invoice approval, and keep the project plan live throughout the study.
Support the provision of productivity, resource, and capacity data and analysis for the Biomarker Platforms' Leadership Team.
Track progress, business performance, concern escalation, and issue resolutions on all BBP deliverables to study/project teams for both internally and externally.
Interface with scientific leads to determine CRO selection and provide invoice approvals for executed work.
Understand and meet the requirements of all relevant policies, SOPs, and external regulations, and comply with local codes of practice, guidelines, and laws.
Contribute to functional process and system improvements to ensure operational excellence.
Support biomarker or other activities as required.
Contribute to a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels through role modelling the values.
Provide regular study level status updates for areas of accountability/responsibility to key stakeholders as required.
Qualifications
Bachelor's or master's degree in Biological/Chemical/Pharmaceutical Sciences, Business, or Project Management.
Experience with clinical PK Bioanalysis, PD Biomarker, Exploratory Biomarker, Immunogenicity, and/or cellular assay delivery requirements.
At least 3 years of related experience.
Knowledge of the drug development process, especially of biotherapeutics, as it applies to technical, logistical, and regulatory requirements for PK bioanalytical, immunogenicity, PD biomarker, and exploratory biomarker assays across multiple technical platforms.
Experience representing the bioanalytical function and driving/delivering bioanalytical strategies and commitments to clinical study teams in a highly matrixed environment.
Experience coordinating multiple demands and timelines (> 6 assets or 30+ clinical studies), stakeholder influence, and managing expectations.
Excellent organizational, interpersonal, and written/verbal communication skills with internal and external partners.
Experience in working with leaders to define project/study strategies and deliverables.
Strong understanding of regulatory guidelines from health authorities and previous work experience of GLP, GCP, and/or GMP.
Strong understanding of clinical PK Bioanalysis, PD Biomarker, Exploratory Biomarker, Immunogenicity, and/or cellular assay technical limitations.
Benefits Healthcare Insurance:
Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance:
Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance:
Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus:
Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.
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As Principal Scientist PMed Operations Specialising in Biomarker Bioanalytical Platforms (BBP), you will lead planning activities across various scientific lab groups in BBP for all BBP-owned measures (Pharmacokinetics, Immunogenicity including ADA and NAb, PD Biomarkers, Diagnostic Biomarkers, and Exploratory Biomarkers) to support clinical study milestones.
You will act as an operations BBP contact for asset-driven clinical study/project teams on all planning activities, including analytical timelines, budgeting, and scientific coordination.
Lead planning activities across various scientific lab groups in BBP for all BBP owned measures to support clinical study milestones.
Coordinate the bioanalytical portion of clinical study support conducted in-house or at CROs, focusing on required clinical assay measure deliverables, resource and budgetary requirements, and protocol review for contract generation.
Oversee the coordination of assay requirements, reagent development, resource placement, and performance tracking for clinical studies.
Work with Project Managers to deliver an accurate project plan for clinical study assay measures, provide budget and resource forecasting, invoice approval, and keep the project plan live throughout the study.
Support the provision of productivity, resource, and capacity data and analysis for the Biomarker Platforms' Leadership Team.
Track progress, business performance, concern escalation, and issue resolutions on all BBP deliverables to study/project teams for both internally and externally.
Interface with scientific leads to determine CRO selection and provide invoice approvals for executed work.
Understand and meet the requirements of all relevant policies, SOPs, and external regulations, and comply with local codes of practice, guidelines, and laws.
Contribute to functional process and system improvements to ensure operational excellence.
Support biomarker or other activities as required.
Contribute to a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels through role modelling the values.
Provide regular study level status updates for areas of accountability/responsibility to key stakeholders as required.
Qualifications
Bachelor's or master's degree in Biological/Chemical/Pharmaceutical Sciences, Business, or Project Management.
Experience with clinical PK Bioanalysis, PD Biomarker, Exploratory Biomarker, Immunogenicity, and/or cellular assay delivery requirements.
At least 3 years of related experience.
Knowledge of the drug development process, especially of biotherapeutics, as it applies to technical, logistical, and regulatory requirements for PK bioanalytical, immunogenicity, PD biomarker, and exploratory biomarker assays across multiple technical platforms.
Experience representing the bioanalytical function and driving/delivering bioanalytical strategies and commitments to clinical study teams in a highly matrixed environment.
Experience coordinating multiple demands and timelines (> 6 assets or 30+ clinical studies), stakeholder influence, and managing expectations.
Excellent organizational, interpersonal, and written/verbal communication skills with internal and external partners.
Experience in working with leaders to define project/study strategies and deliverables.
Strong understanding of regulatory guidelines from health authorities and previous work experience of GLP, GCP, and/or GMP.
Strong understanding of clinical PK Bioanalysis, PD Biomarker, Exploratory Biomarker, Immunogenicity, and/or cellular assay technical limitations.
Benefits Healthcare Insurance:
Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance:
Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance:
Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus:
Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.
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