Senior Director CMC BiologicalsSNAPSHOT:Are you looking for an opportunity to join a cutting-edge companion diagnostics team that’s developed new companion diagnostics products? THEN READ ON! Our client’s technology is being harnessed and supported through a major University Research partner and the Series ‘A’ funding has exceeded all expectations. The person will be responsible for managing the CMC deliverables for all ADC’s in the organizations product offering. Additionally, the applicant will manage CMC for all non-clinical and clinical studies.Immediate fast-track opportunity for a Senior Director CMC Biologics in LA, CA, who possesses:Undergraduate/Graduate degree in life sciences or Chemical/Biological engineering with 10+ years of experience in the biotech industry. The level of the position will depend on the candidate’s experience and level of education.3-5 years of relevant experience Antibody Drug Conjugates is highly desirable. Direct or indirect supervisory experience leading small teams is preferred.Experience with analytical development input to IND, BLA and other regulatory filingsAnalytical method qualification and transfer experience in both early stage (clinical manufacturing) and late stage (commercial enabling) to external partners is required.Experience working external CTL relationships as well as working in internal manufacturing operations is highly desirable.Demonstrated evidence of on-time execution.Ability to effectively lead complex projects with a cross-functional internal/external team.Solid understanding of the fundamentals of ICH and other industry guidelines supporting method development, qualification, and transfer, with a proven ability to assimilate data and growing product knowledge into the broader aspects of CMC development and lifecycle management.Familiarity with and constant attention to the evolving landscape through literature review/publication, conference attendance, industry working group leadership, etc.Ability to troubleshoot complex method investigations combining technical, compliance and business considerations working with cross functional teams.Strong technical foundation in biologics or cell/gene therapy manufacturing process and technology.Ability to effectively communicate complex technical content to a range of audience in oral and written formats.Ability to focus on short term delivery and at the same time directional focus on the long-term goals.Ability and willingness to roll up the sleeves and be hands-on and flexible while we are building the team.Key Responsibilities Include:Direct technical and laboratory activities focused on method development, qualification, and analytical strategy for ADC productsAdvance scientific understanding of biologics products by directing studies aimed at deepening product understandingEstablish collaborative working relationships between Analytical Development, Research, and Quality Control departments both internally and at external CDMOsDevelop scientifically sound and phase appropriate methods to release and characterize productsLead all aspects of method development, transfer, characterization, validation, and investigations requiredSupport product development to ensure timely and robust data analysis; establish control strategy, and incorporation within Tech Ops functionsCollaborate with internal SMEs and CDMOs to automate methods and improve method performancePosition Offers:Base Salary of $180-210KMedical/Dental/VisionPTO/Vacation TimeMore benefits to be shared upon startIf you’d like to explore, send us your resume to admin@snapstaffing.com and we’ll follow up with you right away!

Senior Manager/Director Project ManagementSNAPSHOT:Are you looking for an opportunity to join a cutting-edge companion diagnostics team that’s developed new companion diagnostics products? THEN READ ON! Our client’s technology is being harnessed and supported through a major University Research partner and the Series ‘A’ funding has exceeded all expectations. In this role, the successful applicant will be highly skilled in project management, with an ability to facilitate decision making based on timeline scenario planning and risk assessment. The role reports directly to the head of the Project Management Organization and will support both the company pipeline and the development of companion diagnostics. The Senior Manager/Director Project Management will collaborate closely as a member of a cross-functional team including Discovery, CMC, Clinical Operations, QA, and G&A. Immediate fast-track opportunity for a Senior Manager/Director Clinical Supply Chain in LA, CA, who possesses:Bachelor’s degree in sciences or related field with 4-6+ years pharmaceutical or biotech industry experience in project management ORMS/MBA with 3+ years of pharmaceutical or biotech industry experience in project managementComfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing prioritiesAble to think critically and demonstrate troubleshooting and problem-solving skills.Excellent written, analytical, and oral communication skillsProficiency in Microsoft Office Suite (Outlook, Word, PowerPoint, etc.) and Microsoft Project and/or Smartsheet is required. Strong understanding of drug development and interdependencies. Knowledge in Discovery Research, cGMP manufacturing, Process Development, Clinical development, or Regulatory requirements for biologics and/or medical devices is a strong plus.PMP certifiedStrong interpersonal skills with ability to work effectively across matrix teamsMust be highly organized, proactive, efficient, and agile.Must exhibit high emotional intelligence, with demonstrated ability to successfully negotiate through challenging situations, difficult conversations, and ambiguous assignments.Skillful at building trust and team cohesion, with demonstrated track record of driving and leading teams, and influencing colleagues at all levels of the organization to achieve company goals.Key Responsibilities Include:Provide integrated project management support for early and late stage projects across the portfolio by creating and maintaining comprehensive project schedules, facilitating cross-functional communication and collaboration, and proactively identifying risks to timelinesDemonstrate a clear understanding of project interdependencies and critical path and ensure project milestones are met on time and in full.Track and support regulatory filings and agency responses, ensuring functional leads (discovery research, CMC, and non-clinical) meet deliverables. Maintain documentation of regulatory gaps and implementation of solutions to translate best practices across the portfolio.Support budget analysis across functions and pipeline through detailed tracking of POs and collaboration with G&AOrganize, facilitate, and co-lead team meetings. Develop agendas, prepare minutes, track actions, maintain a risk register, and distribute key project information in a timely manner.Facilitate companion diagnostic development and lab startup activities by ensuring implementation of CAP/CLIA validation requirements through PMA submissionPosition Offers:Base Salary of $130-155KMedical/Dental/VisionPTO/Vacation TimeMore benefits to be shared upon startIf you’d like to explore, send us your resume to admin@snapstaffing.com and we’ll follow up with you right away!

RESEARCH ASSOCIATE(IHC) – Los Angeles, CASNAPSHOT:Are you looking for an opportunity to join a cutting-edge companion diagnostics team that’s developed new companion diagnostics products? THEN READ ON! Our client’s technology is being harnessed and supported through a major University Research partner and the Series ‘A’ funding has exceeded all expectations. As the project progresses you will transition from training onsite within the University lab to a brand-new state of the art facility. Immediate fast-track opportunity for a Research Associate in LA, CA, who possesses:Bachelor’s Degree in chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution OR Associate’s degree in a laboratory science (chemical or biological science) or medical laboratory technology from an accredited institution Ability to function effectively in a global scientific and cultural arena.Excellent interpersonal communication and organizational skills.Continuous quality improvement mindset and attention to detail.Comfortable in a fast-paced small company environment.Proficient in using MS Office Suite and other relevant software tools.Desirable experience with immunohistochemical (IHC) staining and use of a microscope.Desirable experience with Design Control, Product Development or Manufacturing around Medical/Diagnostics devices.Experience in cancer biology is helpful.Key Responsibilities Include:Unlicensed laboratory personnel provide general laboratory assistance and conduct routine experiments in accordance with laboratory and safety protocols, under the direct and constant supervision of the Laboratory Director and/or Clinical Laboratory Scientist.“Direct and constant supervision” means personal observation and critical evaluation of the activity of unlicensed laboratory personnel by a physician and surgeon or personnel licensed during the entire time that the unlicensed laboratory personnel are engaged in the duties specified below.Some examples of IHC specific activities conducted under supervision are:Section blocks and bake slidesLabel blocks or unstained sectionsProcess tissues by embedding in paraffin or performing microtomyStain, cover slip, label slidesStain a Hematoxylin-and-eosin (H&E) sectionPerform immunohistochemistry (IHC)Photograph IHC and/or scan slides using an automated slide scannerFollowing the laboratory’s standard operating procedures (SOPs) for specimen handling and processing, test analyses, reporting, and maintaining records of patient results with supervision.Assist in preventive maintenance and troubleshooting of equipment.Assist in the performance of quality control procedures.Position Offers:Base Salary of $55-90KMedical/Dental/VisionPTO/Vacation Time More benefits to be shared upon startIf you’d like to explore, send us your resume to admin@snapstaffing.com and we’ll follow up with you right away!

Clinical Lab Scientist(Generalist License)SNAPSHOT:Are you looking for an opportunity to join a cutting-edge companion diagnostics team that’s developed new companion diagnostics products? THEN READ ON! Our client’s technology is being harnessed and supported through a major University Research partner and the Series ‘A’ funding has exceeded all expectations. As the project progresses you will transition from training onsite within the University lab to a brand-new state of the art facility. Immediate fast-track opportunity for a Clinical Lab Scientist in LA, CA, who possesses:Bachelor’s Degree in chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution OR Associate’s degree in a laboratory science (chemical or biological science) or medical laboratory technology from an accredited institution Licensed in the state of California to perform low to high complexity testing without direct supervision (Valid Generalist License Required). Excellent interpersonal communication and organizational skills.Ability to multitask and work under pressure with tight deadlines.Continuous quality improvement mindset and attention to detail.Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.Ability to function effectively in a global scientific and cultural arena.Work independently under general supervision. Exercises judgment within defined practices and policies.Proficient in using MS Office Suite, Adobe Acrobat, SharePoint, Veeva Vault and other relevant tools.Desirable experience with immunohistochemical (IHC) staining and use of a microscope.Desirable experience with Design Control, Product Development or Manufacturing around Medical/Diagnostics devices.Experience in cancer biology is helpful.Key Responsibilities Include:Test clinical laboratory specimens according to laboratory policies and procedures and assures that all quality control criteria have been met prior to reporting of test results. Following the laboratory’s standard operating procedures (SOPs) for specimen handling and processing, test analyses, reporting, and maintaining records of patient results.Supports clinical trial activities, including preparation of study and training materials for the study personnel.Administers quality control and is responsible for the operation, maintenance, calibration, and troubleshooting of instruments to ensure proper function and support clinical sample testing via IHC. Adhering to the laboratory’s Quality Control policies with proper communication and documentation of all Quality Control activities, including corrective actions, protocol deviations, instrument and procedural calibrations, and instrument maintenance.Being able to identify problems that may adversely affect test performance and results by troubleshooting the issue and notifying the appropriate supervisor.Performing inventory management and reagent qualification.Contribute to development of process documentation including, SOPs, Work Instructions, and Best Practices related to Companion Diagnostics.Prepares laboratory and assists with audits and inspections.CLS supervises unlicensed personnel, as well as trains all staff (licensed and unlicensed) in all laboratory functions, inclusive of competency assessment.May supervise one or more research assistants/associates.Position Offers:Base Salary of $95-125KMedical/Dental/VisionPTO/Vacation Time More benefits to be shared upon startIf you’d like to explore, send us your resume to admin@snapstaffing.com and we’ll follow up with you right away!