Working for Immunologix

Major Job Function:

The Business Development Associate (BDA) is the foundation of the Immunologix Commercial Team. The Business Development Associate is responsible for generating a qualified sales pipeline that progresses through the Immunologix sales process, resulting in new closed revenue for Immunologix. The BDA is responsible for researching and vetting appropriate companies and stakeholders within a defined territory.  The BDA contacts key stakeholders to schedule initial teleconferences for Business Development Directors (BD). The BDA assists in managing the info line, LinkedIn posts, and Statement of Work (SOW) proposal generation. This role is an entry level position with great growth potential.

Responsibilities:

• Proactively research companies that would be a good business fit for Immunologix.
• Aggressively prospect and generate new leads that will lead to new business opportunities.
• Contact key decision makers to schedule meetings.
• Facilitate client meetings during industry conferences for the Immunologix Commercial teams.
• Maintain general knowledge of all Immunologix services.
• Maintain accurate records of sales related activities in CRM system.
• Handle follow-up related to the sale and completion of contractual documents.
• Maintain sales documentation, including executed contracts, in QuickBase Informatics System and the Immunologix Corporate Network.
• Assist BD team in generation of client facing sales collateral including capabilities presentations, proposals, and Scopes of Work.
• Other duties as assigned by Management of Immunologix Laboratories.
• This role does not require travel. The BDA will work in person from Immunologix Headquarters and Report to the Director of Business Development.

Required Knowledge, skills, and abilities:

• Attention to detail and excellent communication skills, both verbal and written.
• Ability to gather and index information from publicly available sources such as corporate websites, investor reports and scientific forums.
• Skilled in business stakeholder research on LinkedIn Sales Navigator, ZoomInfo and other relevant systems.
• Demonstrated ability to work independently and with others.
• Fluent in Microsoft Word, Microsoft Excel, and other relevant software
• Knowledge of data logging in Salesforce.com or other Customer Relationship Management (CRM) platforms.
• Cloud-based database experience is preferred.
• Understand basic management approaches such as work scheduling, prioritizing and process execution.

Minimum required Education and experience:

• Associate or bachelor’s degree.
• A degree in Life Sciences or Business field is preferred.

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.

Major Job Function:

The senior scientist independently performs 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.  Provides training in scientific practices and serves as a scientific resource for all BDS scientists.

Responsibilities:

• Provides training and serves as a resource to scientific staff on bioanalytical and biomarker related issues and practices
• Develops and validates analytical test methods according to applicable SOPs, test methods and GLP practices.
• Oversees and independently performs sample analysis for client studies using appropriate test methods.
• 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).
• Conducts inventory maintenance, monitoring, and receiving of lab materials (consumables and reagents).
• Oversees the preparation of laboratory solutions and reagents following standardized procedures.
• Review and write SOPs as appropriate or assigned by BDS management
• Other duties assigned by BDS 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 and good communication skills
• Demonstrated ability to work independently and with others

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:

• 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

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.
• May fulfill other jobs/responsibilities as directed by management consistent with skill level and training.

Required Knowledge, skills, and abilities:

• Experience working in a GxP environment is required.
• 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.
• Study management experience including 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.

Minimum required Education and experience:

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

Physical requirements:

• Extended periods of standing or sitting
• Use of computers that involve repetitive hand motion