Working for Immunologix

Major Job Function:

Bioanalytical Laboratory Director to manage large molecule bioanalytical laboratory operations and lead lab team in the development, validation, and implementation of immunoassays in support of pre-clinical and clinical studies.

Responsibilities:

• Provide scientific expertise to develop and validate PK, Immunogenicity and Neutralizing antibody immunoassays (ELISA, MSD, etc.).
• Lead laboratory team and oversee daily laboratory operations pertaining to assay development, validation, sample analysis activities.
• Troubleshoot assays and procedures and advise team members, as needed.
• Manage lab operations, including hands-on-training, review of study data, and other applicable bioanalytical lab functions.
• Oversee the generation of bioanalytical study documents including assay development summaries and test methods.
• Interact with QA to ensure lab operations (e.g., equipment qualification/maintenance, personnel training, SOPs and controlled forms, documentation and recordkeeping, archiving) are in compliance with applicable GLP/GCP regulations, guidances and BDS SOPs.
• Interact with management and clients in planning new projects and test procedures.
• Participate in client visits and audits, as needed.
• Attend and present at scientific conferences.
• Other duties as assigned by Executive Management of Immunologix Laboratories.

Requirements:

• At least 10 years’ experience in regulated environment, CRO, biotech or pharmaceutical company.
• Hands-on supervisory experience on immunoassay development, validation, and sample analysis.
• Knowledge of applicable GLP and GCP regulations and bioanalytical guidelines.
• Prior experience with Watson LIMS.
• Knowledge of key software used to support operations including Microsoft.
• Must be organized and be able to multi-task in a dynamic working environment.
• Excellent verbal and written communication skills.
• Ability to work independently and within teams.

Minimum Required Education and Experience:

• Bachelor’s degree in Biology, Biochemistry, or related field with 10-12 years of relevant laboratory experience
• Master’s degree in Biology, Biochemistry, or related field with 8-10 years of relevant laboratory experience
• D. in Biology, Biochemistry, or related field with 6-8 years or relevant laboratory experience

Physical Requirements:

• Ability to lift 50 pounds and climb ladders.
• Extended periods of standing or sitting.
• Ability to work in small spaces.
• In-person work required.

Major Job Function:

Senior level Scientist to manage the cell-based assay development lab. Must effectively communicate (verbally and written), both internally to project teams and externally to clients, on the development and conduct of assays that support ongoing cell therapy studies. Need to 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 to cross-functional groups. Create and support company and individual continuous improvement initiatives and seek learning opportunities for personal career development, knowledge, and growth. Need to provide training in scientific practices and serve as a senior scientific resource for all Immunologix laboratory scientists.

Responsibilities:

• Provides scientific training and mentoring to cell lab staff.
• Lead laboratory team and oversee daily laboratory operations pertaining to assay development, validation, sample analysis activities
• Develops and validates robust analytical methods according to applicable SOPs and GLP practices.
• Oversee and independently perform cell-based assay development, validation, and sample analysis.
• Independently design, execute, and interpret experiment results while displaying appropriate scientific discretion.
• Follow good documentation practices per GLP guidelines and applicable SOPs.
• Evaluates laboratory practices, training, and relevant SOPs and recommends changes that improve the quality and scientific rigor.
• Record documentation per appropriate format (e.g. controlled form, notebook, logbook).
• Present and discuss experimental results with cross-functional project teams, clients, or externally at scientific conferences.
• Review and/or write applicable laboratory SOPs.
• Perform equipment IQ/OQ/PQ as needed.
• Interact with management and clients in planning new projects and test procedures.
• Participate in client visits and audits, as needed.
• Attend and present at scientific conferences.
• Other duties as assigned by Executive Management of Immunologix Laboratories.

Requirements:

• At least 10 years’ experience in regulated environment, CRO, biotech or pharmaceutical company.
• Hands-on supervisory experience on immunoassay development, validation, and sample analysis.
• Knowledge of applicable GLP and GCP regulations and bioanalytical guidelines.
• Prior experience with Watson LIMS.
• Knowledge of key software used to support operations including Microsoft.
• Must be organized and be able to multi-task in a dynamic working environment.
• Excellent verbal and written communication skills.
• Ability to work independently and within teams.

Minimum Required Education and Experience:

• Bachelor’s degree in Biology, Biochemistry, or related field with 10-12 years of relevant laboratory experience
• Master’s degree in Biology, Biochemistry, or related field with 8-10 years of relevant laboratory experience
• D. in Biology, Biochemistry, or related field with 6-8 years or relevant laboratory experience

Physical Requirements:

• Ability to lift 50 pounds and climb ladders.
• Extended periods of standing or sitting.
• Ability to work in small spaces.
• In-person work required.

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:

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.