Working for Immunologix
Immunologix Laboratories is continuously seeking highly motivated and skilled scientists to enhance our Translational Sciences drug development expertise as well as staff our laboratory at all degree levels BA/BS, Ph.D. in a biological science
Fulfilling
A Rewarding Path
- Drug development experience in bioanalytical and biomarker
- Immunoassay development and validation
- Cell-based assay development and validation
- Good documentation skills consistent with GLP requirements
- CRO laboratory experience
Job Opportunities
MAJOR JOB FUNCTION:
We are seeking a highly driven and motivated scientist to join our Flow Cytometry lab. This individual will play a key role on project teams to generate in vitro data that support all stages of pharmaceutical development. The successful candidate will 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. This 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 to cross-functional groups. The successful individual will create and support company and individual continuous improvement initiatives and seek learning opportunities for personal career development, knowledge, and growth. This individual will provide training in scientific practices and serve as a senior scientific resource for all Immunologix laboratory scientists.
Responsibilities:
- Provides scientific training and mentoring to lab staff
- Develops and validates robust analytical methods according to applicable SOPs and GLP practices
- Oversee and independently perform flow cytometry method 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
Required Knowledge, skills, and abilities:
- Demonstrated expertise in flow cytometry and mammalian cell culture
- Functional expertise in multi-color flow cytometry analyses, gating, compensation, and staining
- Ability to complete documentation in support of bioanalytical test methods in accordance with relevant SOPs and lab practices.
- Attention to detail and ability to 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:
- 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
- Ph. D. in Biology, Biochemistry, or related field with 6-8 years or relevant laboratory experience
Major Job Function:
Provide dedicated scientific partnership and resource to advise, develop, and implement integrated bioanalytical and biomarker strategies and solutions for innovator development programs ranging from discovery to post-market. Work collaboratively across the Translational team to provide our clients with exceptional expertise. This position is fully remote.
Responsibilities:
- Reporting directly to the Head of Translational Sciences.
- Providing bioanalytical and biomarker strategies for multiple novel therapeutic programs, including scientific oversight of assay development & validation, study sample testing and data interpretation.
- Hands-on oversight of method development projects within Immunologix Laboratories (PK, immunogenicity and biomarkers), including reagent generation, LBA and cell-based assay development and assay life cycle management.
- Authoring of relevant clinical and regulatory documents, including written and in-person interactions with health authorities.
- Other duties as assigned by Management of Immunologix Laboratories
Required Knowledge, Skills, and Abilities:
- Develop and implement bioanalytical strategies, including immunogenicity risk assessments, in support of biologics drug development programs that include novel modalities for which regulatory paths have not yet been established
- Provide expert oversight of development and validation of drug concentration (PK) and immunogenicity (ADA and Nab) assays
- Expert interpretation of immunogenicity data, with specific focus on clinical impact and ability to clearly communicate findings to multiple audiences, including health authorities
- Develop and implement biomarker strategies for all therapeutic modalities, with a focus on decision enabling strategies that efficiently progress client projects to key milestones
- Provide expert oversight of development and validation of all associated biomarker assays ensuring methods meet their context of use; oversight of study sample analysis with data interpretation that integrates an understanding of biology, pre-analytical & analytical considerations
- Commitment to team-based collaboration, working seamlessly with broader Translational and Laboratory teams to provide highest quality scientific product for clients
- Present work internally and at national and international meetings, creating content that advances thinking in bioanalytical and biomarker communities; publish relevant manuscripts
- Serve as expert internal resource to advise on all Translational and Laboratory projects
Minimum required Education and Experience:
- PhD or equivalent and 15+ years drug development experience in bioanalytical and/or biomarker sciences with experience in GLP and GCP environments
- Flow cytometry experience in support of cell and gene therapy as well as target engagement and PD biomarkers is a plus
- Excellent verbal and written communications with demonstrated impact internally, externally and with health authorities
- Strong track record of performance in a team environment where focus is on the scientific deliverable and not individual recognition
- Demonstrated ability to think critically, with proven track record of developing fit-for-purpose strategies that deliver impeccable science without unnecessary expenditure of resources
- Ability to build strong relationships, collaborate effectively and influence without authority
- Proven track record of simultaneously leading multiple scientific projects, prioritizing appropriately and delivering on timelines
- Demonstrated ability to quickly absorb new information, develop an understanding of new modalities and disease indications and quickly identify critical questions to be addressed
- Exceptional skill in mentoring scientists to think critically and creatively
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 findings
- Address minor QA findings such as formatting and grammatical corrections
- Create draft responses to QA audits
- Write drafts of bioanalytical reports
- Manage day to day sample analysis needs such as requesting samples, regressing data, and submitting table generation requests
- Other duties as assigned by Immunologix Management
- Monitor milestones in Raptor
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:
- 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 oral and written communication skills, and ability to multitask with excellent time management
- Must work effectively within teams and with clients to meet objectives under time constraints
- Knowledge of key software used to support bioanalytical analysis including Watson LIMS, Microsoft Excel, Microsoft Word, and others
- Demonstrated ability to work independently and with others
MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
- High School diploma with 2-4 years of relevant experience
- Bachelor's degree in Biology, Biochemistry, or related field with 0-2 years of relevant laboratory experience
PHYSICAL REQUIREMENTS:
- Extended periods of standing or sitting
- Use of computers that involve repetitive hand motion
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.
Please send your resume and completed application to apply@immunologixlabs.com to apply for one of the above job openings.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.