Working for Immunologix

We are seeking an exceptional scientist to join the Method Development (Sci II/III), Critical Reagent (Sci I/II/III), Cell-based assay (Sci I/II/III), or Production (Sci I/II) teams with a motivation to bring life-changing medicines faster to the patients that need them.  The individual will play a key role on project teams to generate in vitro data that support all stages of Development (preclinical and clinical). The successful candidate will effectively communicate (verbally and written) to project teams on the development and conduct of assays to support PK, PD, ADA, Nab, Biomarker, and cell-and-gene therapy studies.  For senior level roles, the scientist will utilize all available resources to make scientifically driven decisions that progress projects faster by designing, troubleshooting, interpreting assay data, and presenting their work to project teams or cross-functionally and by ensuring team alignment before moving forward.  The successful individual will create and support company and individual continuous improvement initiatives and seek learning opportunities for personal career development, knowledge, and growth.

MAJOR JOB FUNCTION:

Under general supervision the laboratory scientist I performs routine bioanalytical test methods to support method development, validation, and sample analysis per relevant SOPs and test methods. Prepares and reports the results to bioanalytical Principal Investigator and/or supervisor.

Key words: Bioanalytical method development, PK, ADA, nAB, Cell-based, ELISA, MSD, ELLA, RT-PCR, Flow Cytometry, and/or Cell culture.  Other desired skills include FPLC, Octet, critical reagent conjugations and characterization.

RESPONSIBILITIES:

• Conduct lab operations according to applicable SOPs, test methods and GLP practices.
• Follow good documentation practices per GLP guidelines and applicable SOPs.
• Record documentation per appropriate format (e.g. controlled form, notebook, logbook).
• Assist in inventory maintenance, monitoring, and receiving of lab materials (consumables and reagents).
• Prepare laboratory solutions and reagents following standardized procedures.
• Monitor the laboratory areas for cleanliness.
• Ability to complete documentation in support of bioanalytical test methods that maintains with relevant SOPs and lab practices.
• Knowledge of laboratory procedures, practices, and applicable SOPs.
• Ability to analyze and interpret results of assigned test methods.
• Attention to detail and good communication skills
• Demonstrated ability to work independently and with others
• Ability to use routine laboratory software such as Microsoft Word, Microsoft Excel, Softmax, Discovery Workbench, and other relevant software.
• Author SOPs and test methods.
• Other duties assigned by management

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

• Ability to complete documentation in support of bioanalytical test methods that maintains with relevant SOPs and lab practices.
• Knowledge of laboratory procedures, practices, and applicable SOPs.
• Ability to analyze and interpret results of assigned test methods.
• Attention to detail and appropriately identify and escalate issues
• Excellent verbal and written communication skills
• Communicate timely and effectively with all levels of the organization
• Demonstrated ability to work independently and with others
• Team-based project execution in a matrix organization is highly desired.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

• High School diploma or equivalent with 4-6 years of laboratory experience
• Bachelor's degree in Biology, Biochemistry, or related field with 2-4 years of relevant laboratory experience
• Master's degree (or higher) in Biology, Biochemistry, or related field with 0-2 years of relevant laboratory experience

We are seeking an exceptional scientist to join the Method Development (Sci II/III), Critical Reagent (Sci I/II/III), Cell-based assay (Sci I/II/III), or Production (Sci I/II) teams with a motivation to bring life-changing medicines faster to the patients that need them.  The individual will play a key role on project teams to generate in vitro data that support all stages of Development (preclinical and clinical). The successful candidate will effectively communicate (verbally and written) to project teams on the development and conduct of assays to support PK, PD, ADA, Nab, Biomarker, and cell-and-gene therapy studies.  For senior level roles, the scientist will utilize all available resources to make scientifically driven decisions that progress projects faster by designing, troubleshooting, interpreting assay data, and presenting their work to project teams or cross-functionally and by ensuring team alignment before moving forward.  The successful individual will create and support company and individual continuous improvement initiatives and seek learning opportunities for personal career development, knowledge, and growth.

MAJOR JOB FUNCTION:

Under minimal supervision the laboratory scientist II performs routine bioanalytical test methods to support method development, validation, and sample analysis per relevant SOPs and test methods. Prepares, reports, and presents the results to bioanalytical Principal Investigator and/or supervisor.

Key words: Bioanalytical method development, PK, ADA, nAB, Cell-based, ELISA, MSD, ELLA, RT-PCR, Flow Cytometry, and/or Cell culture.  Other desired skills include FPLC, Octet, critical reagent conjugations and characterization.

RESPONSIBILITIES:

• Conduct laboratory work to develop and validate analytical test methods according to applicable SOPs, test methods and GLP practices.
• Perform sample analysis for client studies with minimal supervision.
• Follow good documentation practices per GLP guidelines and applicable SOPs.
• Participate in instrument qualification, maintenance, training, and drafting SOPs
• Record documentation per appropriate format (e.g. controlled form, notebook, logbook).
• Conduct inventory maintenance, monitoring, and receiving of lab materials (consumables and reagents).
• Prepare laboratory solutions and reagents following standardized procedures.
• Review and write SOPs as appropriate or assigned by Immunologix Laboratories management
• Monitor the laboratory areas for cleanliness.
• Authors SOPs and test methods
• Mentor junior scientists on scientific critical thinking skills
• Other duties assigned by management

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

• Ability to complete documentation in support of bioanalytical test methods that maintains with relevant SOPs and lab practices.
• Knowledge of laboratory procedures, practices, and applicable SOPs.
• Ability to analyze, interpret, and present results of assigned test methods.
• Attention to detail and appropriately identify and escalate issues
• Excellent verbal and written communication skills
• Demonstrated ability to work independently and with others
• Communicate timely and effectively with all levels of the organization
• Team-based project execution in a matrix organization is highly desired.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

• High School diploma or equivalent with 6-8 years of laboratory experience
• Bachelor’s degree in Biology, Biochemistry, or related field with 4-6 years of laboratory experience
• Master’s degree in Biology, Biochemistry, or related field with 2-4 years of relevant laboratory experience
• Ph.D. in Biology, Biochemistry, or related field with 0-2 years of relevant laboratory experience

We are seeking an exceptional scientist to join the Method Development (Sci II/III), Critical Reagent (Sci I/II/III), Cell-based assay (Sci I/II/III), or Production (Sci I/II) teams with a motivation to bring life-changing medicines faster to the patients that need them.  The individual will play a key role on project teams to generate in vitro data that support all stages of Development (preclinical and clinical). The successful candidate will effectively communicate (verbally and written) to project teams on the development and conduct of assays to support PK, PD, ADA, Nab, Biomarker, and cell-and-gene therapy studies.  For senior level roles, the scientist will utilize all available resources to make scientifically driven decisions that progress projects faster by designing, troubleshooting, interpreting assay data, and presenting their work to project teams or cross-functionally and by ensuring team alignment before moving forward.  The successful individual will create and support company and individual continuous improvement initiatives and seek learning opportunities for personal career development, knowledge, and growth.

MAJOR JOB FUNCTION:

The laboratory scientist III independently performs routine bioanalytical test methods to support method development, validation, and sample analysis per relevant SOPs and test methods. Prepares, reports, and presents the results to bioanalytical Principal Investigator and/or supervisor.

Key words: Bioanalytical method development, PK, ADA, nAB, Cell-based, ELISA, MSD, ELLA, RT-PCR, Flow Cytometry, and/or Cell culture.  Other desired skills include FPLC, Octet, critical reagent conjugations and characterization.

RESPONSIBILITIES:

• Develops and validates analytical test methods according to applicable SOPs, test methods and GLP practices.
• Independently performs sample analysis for client studies using appropriate test methods.
• Follow good documentation practices per GLP guidelines and applicable SOPs.
• Performs instrument qualification, maintenance, training, and drafting SOPs.
• Record documentation per appropriate format (e.g. controlled form, notebook, logbook).
• Conducts inventory maintenance, monitoring, and receiving of lab materials (consumables and reagents).
• Prepares laboratory solutions and reagents following standardized procedures.
• Review and write SOPs as appropriate or assigned by BDS management
• Monitor the laboratory areas for cleanliness.
• Authors SOPs and test methods
• Mentor junior scientists on scientific critical thinking skills
• Leads and serves on continuous improvement teams to support key initiatives
• Other duties assigned by management

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

• Ability to independently complete documentation in support of bioanalytical test methods that maintains with relevant SOPs and lab practices.
• Expertise and knowledge of laboratory procedures, practices, and applicable SOPs.
• Knowledge of industry practices for relevant bioanalytical analysis.
• Ability to analyze, interpret, and present results of assigned test methods.
• Attention to detail
• Excellent verbal and written communication skills and appropriately identify and escalate issues
• Demonstrated ability to work independently and with others
• Communicate timely and effectively with all levels of the organization
• Team-based project execution in a matrix organization is highly desired.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

• High School diploma or equivalent with 8-10 years of laboratory experience
• Bachelor's degree in Biology, Biochemistry, or related field with 6-8 years of relevant laboratory experience
• Master's degree in Biology, Biochemistry, or related field with 4-6 years of relevant laboratory experience
• Ph.D. in Biology, Biochemistry, or related field with 2-4 years of relevant laboratory experience.

MAJOR JOB FUNCTION:

Under minimal supervision, the Principal Investigator I conducts and manages regulated (e.g. GLP, GCP) and non-regulated bioanalytical studies, representing the Sponsor as Principal Investigator. Ensures the bioanalytical studies meet all the requirements of the study protocol, Immunologix Laboratories SOPs and appropriate regulations. Ensures the scientific integrity of the study documentation, data, and report are of the highest quality and in compliance with appropriate regulations via quality processes as they pertain to the conduct of bioanalytical studies.

RESPONSIBILITIES:

• Regulatory and scientific oversight of regulated and non-regulated bioanalytical studies.

• Analysis, interpretation, and approval of study data.

• Primary point of contact for Sponsor and/or Study Director

• Preparation and/or review of Sample Analysis Plans (SAP) and validation plans, and ensure studies are followed according to the plans and applicable SOPs.

• New project initiation including but not limited to: setting up Sponsor and study specific files Watson LIMS study design, sponsor meetings and updates to Master Schedule.

• Preparation and creation of analytical batches, data reduction, data review and preparation of final analytical reports that are written according to SOPs and ready for QC/QAU review.

• Ensure all study personnel are trained on applicable SOPs, protocols and amendments.

• Maintain metrics to track workflow. Assist in the development and maintenance of review schedules and functional area metrics as applicable.

• Preparation and review of SOP, BP, or protocol deviation documentation; associated corrective actions and prompt notification of the Study Director and/or Sponsor.

• In coordination with Lab Management, Method Development/Validation, QC, QA and Reagent Groups for ensure that adequate resources are available for proper execution of the assay schedule.

• Scheduling and coordination with QC of study review, addressing finding promptly, with corrective actions.

• Scheduling and coordination with QAU of audit events, including in-process audits address and correct issues arising from quality assurance audits promptly, with corrective actions.

• Coordinate with Management, method development and validation staff to troubleshoot methods as needed including conduct and reporting of laboratory investigations.

• Sponsor interactions including maintenance of meeting minutes, critical Sponsor communication documentation and timely transfer of data and records.

• Responsible for updating report and project tracking to ensure timelines are being met.

• Contribute to writing and review of SOPs.

MAJOR JOB FUNCTION:

Under general supervision, the Project Coordinator supports regulated (e.g. GLP, GCP) and non- regulated bioanalytical studies and works directly with the Bioanalytical Principal Investigator.

Supports bioanalytical studies to ensure they meet all the requirements of the study protocol, Immunologix SOPs, and appropriate regulations.

RESPONSIBILITIES:

• Supports regulated and non-regulated bioanalytical studies to ensure they are compliant with all relevant regulatory regulations.
• Address QC
• Address minor QA findings such as formatting and grammatical
• Create draft responses to QA
• Write drafts of bioanalytical
• Manage day to day sample analysis needs such as requesting samples, regressing data, and submitting table generation
• Other duties as assigned by Immunologix
• Monitor milestones in

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

• Knowledge of laboratory procedures, practices, and applicable
• Knowledge of industry practices for relevant bioanalytical
• Ability to analyze, interpret, and present results of assigned test
• Attention to detail, excellent oral and written communication skills, and ability to multitask with excellent time
• Must work effectively within teams and with clients to meet objectives under time
• Knowledge of key software used to support bioanalytical analysis including Watson LIMS, Microsoft Excel, Microsoft Word, and
• Demonstrated ability to work independently and with

MAJOR JOB FUNCTION:

With general supervision, conduct quality control (QC) review and evaluation of laboratory results, documentation and reports for completeness, accuracy and compliance with appropriate processes and regulations. Provide material support to the Bioanalytical Principal Investigators including, but not limited to, review of data tables.

RESPONSIBILITIES:

• Actively participate in the Quality Management System.
• Participate in end-user support and act as system owner for the Immunologix Laboratories electronic Quality Management System.
• Generate data tables to support bioanalytical studies.
• Work with Bioanalytical PI to respond to internal and external audits.
• Understand and follow all procedures and processes required for work performed.
• Conduct operations according to applicable SOPs, test methods and appropriate regulatory requirements (e.g. GLP) and good documentation practices.
• Review study data and documentation to ensure completeness, accuracy and compliance with appropriate regulations and processes.
• Evaluate and suggest improvements to processes, forms and templates to improve efficiency, completeness and accuracy.
• Record documentation per appropriate format (e.g. controlled form, notebook, logbook).
• Effectively communicate with management and other laboratory personnel to provide feedback and to prioritize based on business needs.
• Follow good documentation practices per GLP guidelines and applicable SOPs.
• Other duties as assigned by Management

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

• Knowledge of laboratory procedures, practices, and applicable SOPs.
• Ability to complete documentation in a GLP compliant manner in accordance with relevant SOPs and laboratory practices.
• Attention to detail and good communication skills.
• Demonstrated ability to work independently and with others.
• Ability to use routine software such as Microsoft Word, Excel, and other relevant software.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

• High School diploma with 2-4 years of laboratory experience.
• Associate degree or equivalent with 1-2 years of laboratory experience.
• Bachelor’s degree in Life Sciences or related field with 0-2 years of relevant laboratory experience.

PHYSICAL REQUIREMENTS:

• Use of personal protective equipment for extended periods of time.
• Extended periods of standing or sitting.
• Use of laboratory equipment which may involve repetitive motion.

Major Job Function:

Directs business and high-level project management process for assigned key clients on behalf of Immunologix Laboratories. Main roles are to constantly ensure transparent communication, project milestones and delivery, and expand business collaborations with assigned clients by acquiring new programs and adding service solutions. Primary owner, administrator, and developer for to Immunologix informatics platform (RAPTOR), with supporting active collaboration with laboratory logistics and management.

Responsibilities:

• Primary point of contact for business and operations for assigned key clients. Drives all routine and ad-hoc meetings and communications between clients and operations/PIs.
• Ensures that Immunologix’ teams have clear understanding of client’s expectations (SOWs, overall conduct of studies, study specific requirements, timelines, deliverables etc.) by collecting client specific information, updates, and pain points and communicating this information to Principal Investigators, Sample Management, Laboratory Managers and VPs, Business management, CEO, and other Immunologix stakeholders as appropriate.
• Leads the overall project portfolio from assigned clients. Ensures complete intake process logistics, award, and kick-off activities transition to Principal Investigators for efficient execution. Although there are no employees to directly manage for this position, skillful team coordination and interdependence is at the core of this position. The PI’s priorities need to be managed carefully to ensure full alignment with clients’ expectations.
• Issues proposals/quotations to clients. Leads all MSA, SOW and Work Scope Change activities for the client.
• Issues monthly update reports to management. Report primarily on status of current studies, challenges, new studies from existing and new molecule programs.
• Primary owner, administrator, and developer for to Immunologix informatics platform (RAPTOR). Work with platform provider (Metrendalytics), host (Quickbase), and all key internal stakeholders to ensure efficient and complete implementation, training, adherence, and maintenance of the system.  Supporting active collaboration with laboratory logistics and management.
• Other duties as assigned by Management of Immunologix Laboratories
• Reports to Executive Director, Business Development.

Required Knowledge, skills, and abilities:

• 2 years client account management experience, life sciences preferred
• Attention to detail and good communication skills
• Demonstrated ability to work independently and with others
• Fluent in Microsoft Word, Microsoft Excel, and other relevant software
• com or other Customer Relationship Management (CRM) platform
• Cloud-based database experience is preferred

Minimum required Education and experience:

• Associates or bachelor’s degree. Degree in Life Sciences or Business field is preferred.

Physical requirements:

• Potential office/hybrid to be determined.

Major Job Function:

Initiate, develop, and submit to Business Development client-ready Statement Of Work (SOW) proposals.  Intake initial project information from Business Development (BD)/Translational Sciences, followed by draft and presentation at SOW triage meetings.  Make all final adjustments and provide to BD stakeholders for submission to client.

Responsibilities:

• Train and master SOW development process in cloud-based Quickbase informatics system: Salesforce.com Opportunities, SOW Overview, Responsibilities, Service Rates, Pass-through sections, Terms, and Templates.
• Initiate and develop SOW proposals via intake process from Business Development.
• Schedule and attend SOW Triage meetings for proposals. Update all pertinent SOW details as needed.
• Submit client-ready SOW proposals to BD representative.
• Receive signed/completed agreements from BD, file in cloud-based Quickbase informatics system and company network.
• Train and master Work Scope Change process (WSC). Receive WSC requests via cloud-based informatics system application, prepare, and submit to BD representative.
• Update/correct Service Rates and Terms as needed.
• Other duties as assigned by Management of Immunologix Laboratories.
• Reports to Executive Director of Business Development.

Required Knowledge, skills, and abilities:

• Attention to detail and good communication skills
• Demonstrated ability to work independently and with others
• Fluent in Microsoft Word, Microsoft Excel, and other relevant software
• com or other Customer Relationship Management (CRM) platform
• Cloud-based database experience is preferred

Minimum required Education and experience:

• Associates or bachelor’s degree. Degree in Life Sciences or Business field is preferred.

Physical requirements:

• Potential office/hybrid to be determined.