Working for Immunologix

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:

The Business Development (BD) Director is the foundation of the Immunologix Commercial Team. The BD Director is responsible for identifying and developing new business opportunities. expanding the Immunologix brand, driving the growth and expansion of the company’s services and growing the client base. The BD Director will develop a network of contacts to attract new clients, and research new market opportunities. The BD Director will actively seek and generate a qualified sales pipeline that progresses through the Immunologix sales process. The BD Director is responsible for researching and vetting appropriate companies and stakeholders within a defined territory.  This role combines strategic planning, client relationship management, and market analysis to identify new business opportunities, expand existing client relationships, and contribute to the company’s revenue growth. The ideal candidate will have a deep understanding of bioanalytical and biomarker methodologies, regulatory requirements, and industry trends, alongside strong experience in sales and business development.

Responsibilities:

• Strategic Planning and Market Analysis:
  • Develop and implement business development strategies that align with company goals and objectives.
  • Conduct market research to identify emerging trends, potential clients, and competitive landscape in bioanalytical and biomarker services.
  • Analyze client needs and service gaps to tailor the company’s offerings to meet market demands.
  • Develops and strengthens internal and external relationships that will lead to increased lead generation and market share.
• Client Relationship Management:
• Identifies and develops new business opportunities, builds, and maintains relationships with new and existing clients.
• Negotiates contracts and executes Statement of Work (SOW) for clients.
• • Act as the primary point of contact for clients, addressing their needs, providing solutions, and ensuring high levels of customer satisfaction.
• Sales and Revenue Growth:
• Aggressively prospects and generates qualified new leads that will lead to new business opportunities.
• Develops in-depth knowledge of company offerings to identify profitable business opportunities.
• Contacts key decision makers to schedule meetings and present Immunologix capabilities to prospective clients.
• Lead the sales process from initial contact through to contract negotiation and closing.
• Develop proposals, presentations, and pricing strategies tailored to client needs and aligned with company objectives.
• Meet or exceed sales targets, contributing to the company’s overall revenue growth.
• Develops and manages strategic partnerships to grow business.
• Evaluates existing partnerships and sales efforts with an eye toward building sustainable, long-term growth.
• Expands the profile and reach of the company and its brands.
• Provides advice on promotion strategies to garner new business.
• Cross-Functional Collaboration:
  • Work closely with scientific, operational, and marketing teams to ensure alignment of business development efforts with company capabilities and goals.
  • Provide input into the development of new services and products based on market demand and client feedback.
  • Collaborate with internal teams to ensure seamless onboarding and project execution for new clients.
• Ensures that Immunologix’ teams have clear understanding of client’s expectations (SOWs, overall conduct of studies, study specific requirements, timelines, deliverables etc.) by working with key stakeholders to collect client specific information, and communicating this information to Principal Investigators, and other Immunologix stakeholders as appropriate.
• Prepares and assists in gathering all documentation required for requests for proposals (RFPs).

• Additional Responsibilities:
  • Fosters and works to maintain an entrepreneurial growth culture throughout the company and across all teams and work functions.
  • Assists in presenting business or marketing opportunities to company executives and management.
  • Facilitate client meetings during industry conferences.
  • 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.
  • Other duties as assigned by Management of Immunologix Laboratories.

• The BD Director is a remote position and will require travel to clients, industry conferences and Immunologix Headquarters.
• The Business Development Director reports to the Chief Commercial Officer.

Required Knowledge, skills, and abilities:

• Min 5 years’ business development, or sales experience with a proven track record of successfully driving sales and building client relationships in the regulated bioanalytical and biomarker space.
• Possess excellent communications and negotiation skills, both verbal and written.
• Detail-oriented and persuasive
• 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 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.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong business acumen.
• Understands basic management approaches such as work scheduling, prioritizing and process execution.

Minimum required Education and experience:

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

MAJOR JOB FUNCTION:

Under minimal supervision, the Principal Investigator I conducts and manages regulated (e.g. GLP, GCP) and non-regulated PK, immunogenicity (ADA and NAb), and Biomarker studies. 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 bioanalytical studies, specifically PK, ADA, NAb, and Biomarker.

· 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.

· Communicate professionally with both internal and external individuals and groups.

· Clear and effective communication with Sponsors, providing a great client experience.

· 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.

· Familiarity with Watson LIMS

· 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

· Ph.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

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