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NorthernBio · 2 months ago

Senior Protein Scientist

Portage, MI, US

Full-time

Onsite

Senior Level

6+ years exp

Northern Bio is focused on advancing biopharmaceutical development, and they are seeking a Senior Protein Scientist responsible for planning, conducting, and analyzing protein assay method development and validation experiments. The role involves significant expertise in anti-drug antibody analysis and pharmacokinetic bioanalysis, ensuring compliance with regulatory guidelines and scientific practices.

Biotechnology

Responsibilities

Ability to develop, optimize, qualify, and validate new ADA assays in both pre-clinical and clinical laboratory environments

Ability to develop, optimize, qualify, and validate new assays to assess the pharmacokinetics of large-molecule drug candidates in both pre-clinical and clinical laboratory environments

The scientist must possess a strong understanding of biomarker and anti-drug-antibody (ADA) analysis and be able to execute assays within these areas under the guidance of the Study Director/Principle Investigator, in collaboration with other scientific staff leading the method development and validation procedures

Strong understanding of the FDA ADA guidance for Immunogenicity Testing of Therapeutic Protein Products. Must possess the ability to design assays that meet, or exceed, testing requirements outlined in the available guidance documents and provide scientific justification for deviating from the regulatory testing requirements

Strong understanding of the ICH M10 guideline for bioanalytical method validation and analysis of study samples. Must possess the ability to design assays that meet, or exceed, testing requirements outlined in the available guidance documents and provide scientific justification for deviating from the regulatory testing requirements

Conduct sample analysis of various biological matrices in support of pre-clinical and clinical studies for ADA, PK, and biomarker assays

Lead the department in onboarding new instrumentation and applications. This includes, but is not limited to, developing IQOQ documents and working with IT personnel on Computer System Validation (CSV) script development and execution, while simultaneously implementing SOPs and procedures on operation and maintenance

Study monitoring as a lead scientist and data review, as needed. The Senior Scientist is expected to have a full understanding of progress and status of method development and validation studies in their purview and relay this information to management and study directors in a timely and comprehensive manner

Ensures that unforeseen circumstances that may affect the quality and integrity of the laboratory study are noted when they occur, and corrective action is taken and documented

Interfacing with Sponsors, Vendors, Contributing Scientists, and Principal Investigators, as needed

Establish relationships with clients and secure trust through high quality scientific execution, with timely and accurate updates provided through sponsors meetings, method development summaries, and presentations. Responsible for providing scientific guidance and direction during interactions with clients, when necessary

Drive efficiencies through automation/new technologies in assay development, validation, sample preparation, analysis, and reporting

Write and review reports, methods, and SOPs

Maintain laboratory and freezer inventory, manage instrumentation maintenance and troubleshooting

Mentor and guide junior scientists and technicians

May serve as the Principal Investigator or Study Director for internal and external studies. Maintains the overall responsibility for the technical conduct of the study, interpretation, and reporting of results in accordance with regulatory agencies, protocols, amendments, methods, and standard operating procedures

All other duties as assigned

Qualification

ADA analysisFDA ADA guidanceICH M10 guidelineELISABioanalytical assay developmentLIMS familiarityMicrosoft WordMicrosoft ExcelMicrosoft OutlookAnalytical skillsProblem-solving skillsCommunication skillsTeamworkLeadership

Required

Strong understanding of biomarker and anti-drug-antibody (ADA) analysis

Strong understanding of the FDA ADA guidance for Immunogenicity Testing of Therapeutic Protein Products

Strong understanding of the ICH M10 guideline for bioanalytical method validation and analysis of study samples

Ability to develop, optimize, qualify, and validate new ADA assays in both pre-clinical and clinical laboratory environments

Ability to develop, optimize, qualify, and validate new assays to assess the pharmacokinetics of large-molecule drug candidates in both pre-clinical and clinical laboratory environments

Possess a strong understanding of biomarker and anti-drug-antibody (ADA) analysis and be able to execute assays within these areas under the guidance of the Study Director/Principle Investigator

Ability to design assays that meet, or exceed, testing requirements outlined in the available guidance documents and provide scientific justification for deviating from the regulatory testing requirements

Conduct sample analysis of various biological matrices in support of pre-clinical and clinical studies for ADA, PK, and biomarker assays

Lead the department in onboarding new instrumentation and applications, including developing IQOQ documents and working with IT personnel on Computer System Validation (CSV) script development and execution

Study monitoring as a lead scientist and data review, as needed

Ensures that unforeseen circumstances that may affect the quality and integrity of the laboratory study are noted when they occur, and corrective action is taken and documented

Interfacing with Sponsors, Vendors, Contributing Scientists, and Principal Investigators, as needed

Drive efficiencies through automation/new technologies in assay development, validation, sample preparation, analysis, and reporting

Write and review reports, methods, and SOPs

Maintain laboratory and freezer inventory, manage instrumentation maintenance and troubleshooting

Mentor and guide junior scientists and technicians

May serve as the Principal Investigator or Study Director for internal and external studies

Bachelor's degree or equivalent in a scientific related discipline

Minimum of 6 years of related experience

Experience with ELISA, MSD, Luminex, GLP-compliant bioanalytical assay development, validation, and sample analysis

Familiarity with LIMS, and large molecule bioanalysis is a huge plus

Experience with regulated studies and compliance guidelines for bioanalytical assays, including but not limited to the ICH M10 guideline for bioanalytical method validation and analysis

Computer skills required: Microsoft Word, Excel, Outlook

Excellent analytical and problem-solving skills

Excellent verbal and written communication skills; ability to design, interpret, and present complex scientific data in a team environment is required

Self-starter, able to prioritize work and work efficiently with minimal supervision

Collaboration

Teamwork

Leadership

Ability to lift and carry up to 50lbs

Ability to don and wear personal protective gear, including respirators

The person filling this position will spend approximately 20% in an office setting and 80% in the laboratory

There will be exposure to animal pathogens and chemicals

There will be handling of, and/or exposure to animal tissue and zoonotic organisms